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): June 3, 2016
SHIRE PLC
(Exact Name of Registrant as Specified in Its Charter)
Jersey, Channel Islands |
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0-29630 |
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98-0601486 |
(State or Other Jurisdiction of
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(Commission File Number) |
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(I.R.S. Employer
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5 Riverwalk, Citywest Business Campus, Dublin
24, Republic of Ireland
(Address of Principal Executive Offices)
Registrants telephone number, including area code: +353 1 429 7700
(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 Instruction A.2.):
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))
Item 1.01. Entry into a Material Definitive Agreement.
On June 3, 2016, Shire plc ( Shire ) entered into a Second Supplemental Indenture (the Second Supplemental Indenture ) to the Indenture, dated June 23, 2015, between Baxalta Incorporated, a Delaware corporation and a wholly-owned subsidiary of Shire ( Baxalta ) and The Bank of New York Mellon Trust Company, N.A., as trustee (the Trustee ) (as supplemented by the First Supplemental Indenture, dated June 23, 2015 (the First Supplemental Indenture ), the Indenture ), relating to the guarantee by Shire of the outstanding notes issued by Baxalta under the Indenture, consisting of $375,000,000 aggregate principal amount of its floating rate senior notes due 2018 (the Floating Rate Notes ), $375,000,000 aggregate principal amount of its 2.000% senior notes due 2018 (the 2018 Notes ), $1,000,000,000 aggregate principal amount of its 2.875% senior notes due 2020 (the 2020 Notes ), $500,000,000 aggregate principal amount of its 3.600% senior notes due 2022 (the 2022 Notes ), $1,750,000,000 aggregate principal amount of its 4.000% senior notes due 2025 (the 2025 Notes ) and $1,000,000,000 aggregate principal amount of its 5.250% senior notes due 2045 (the 2045 Notes and together with the 2018 Notes, the 2020 Notes, the 2022 Notes and the 2025 Notes, the Fixed Rate Notes ). The Fixed Rate Notes and the Floating Rate Notes are collectively hereinafter referred to as the Notes , and each of the Floating Rate Notes, the 2018 Notes, the 2020 Notes, the 2022 Notes, the 2025 Notes and the 2045 Notes are hereinafter referred to as a series of Notes.
Under the terms of the Second Supplemental Indenture, Shire fully and unconditionally guarantees to the holders of each series of the Notes and to the Trustee the full and punctual payment when due, whether at stated maturity, by acceleration or otherwise, of the principal of, premium, if any, on and interest on each series of Notes and any other amounts due and payable under the Indenture, subject to any applicable grace period or notice requirement or both.
The foregoing descriptions of the Indenture, the First Supplemental Indenture and the Second Supplemental Indenture do not purport to be complete and are qualified in their entirety by reference to the Indenture, the First Supplemental Indenture, and the Second Supplemental Indenture, which are filed as Exhibits 4.1, 4.2 and 4.3, respectively, to this Current Report on Form 8-K, each of which are incorporated by reference into this Item 1.01.
Item 2.01. Completion of Acquisition or Disposition of Assets.
As previously disclosed, on January 11, 2016, Shire entered into an Agreement and Plan of Merger (the Merger Agreement ) with Baxalta and BearTracks, Inc., a Delaware corporation and a wholly-owned subsidiary of Shire ( Merger Sub ), pursuant to which, upon the terms and subject to the conditions thereof, Merger Sub was merged with and into Baxalta (the Merger ), with Baxalta surviving as a wholly-owned subsidiary of Shire.
At the effective time (the Effective Time ) of the Merger on June 3, 2016, each outstanding share of Baxalta common stock, par value $0.01 per share (each a Share ) (other than: (i) Shares held by Baxalta as treasury stock, (ii) any Shares owned by Shire, Merger Sub or any other direct or indirect wholly-owned subsidiary of Shire, and (iii) Shares held by Baxalta stockholders who have properly exercised appraisal rights with respect to such Shares in accordance with Section 262 of the General Corporation Law of the State of Delaware) was canceled and converted into the right to receive, in each case without interest and subject to any applicable withholding taxes: (i) $18.00 in cash and (ii)(a) 0.1482 of a Shire ADS or (b) if a Baxalta stockholder validly elected, 0.4446 of a Shire ordinary share in lieu of such fraction of a Shire ADS described in (ii)(a) above.
Dyax Corp. ( Dyax ), a wholly-owned subsidiary of Shire, paid approximately $12.37 billion in cash and Shire issued approximately 305.2 million Shire ordinary shares in the aggregate in consideration in the Merger.
Shires wholly-owned subsidiary Shire Acquisitions Investments Ireland Limited ( SAIIL ) indirectly provided Dyax with the necessary funds to fund the aggregate cash consideration through borrowings under the $18.0 billion bridge facilities agreement with, among others, Barclays Bank PLC and Morgan Stanley Bank International Limited, acting as mandated lead arrangers and book runners (the January 2016 Facilities Agreement ), to which SAIIL acceded as an additional borrower and additional guarantor on April 1, 2016. The January 2016 Facilities Agreement comprises two credit facilities: (i) a $13.0 billion term loan facility which, subject to a one year extension option exercisable at Shires option, matures on January 11, 2017 ( January 2016 Facility A ) and (ii) a $5.0 billion revolving loan facility which, subject to a one year extension option exercisable at Shires option, matures on January 11, 2017. The January 2016 Facility A was used to finance the cash consideration payable and certain costs related to the Merger.
The foregoing description of the Merger and the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the Merger Agreement, which is filed as Exhibit 2.1 to the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (the SEC ) by Shire on January 11, 2016, and which is incorporated herein by reference.
Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
As previously disclosed, on January 11, 2016, Shire entered into the January 2016 Facilities Agreement. As of April 1, 2016, SAIIL acceded to the January 2016 Facilities Agreement as an additional guarantor and an additional borrower. In connection with the consummation of the Merger, on May 31, 2016, SAIIL delivered a utilization request providing for the drawdown of an amount equal to $12.39 billion under the January 2016 Facility A. Further information regarding the January 2016 Facilities Agreement is set forth in Shires Current Report on Form 8-K filed on January 11, 2016, which is incorporated herein by reference. The information about the Indenture, the First Supplemental Indenture and the Second Supplemental Indenture in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
As previously disclosed, upon completion of the Merger and pursuant to the terms of the Merger Agreement, Gail D. Fosler and Albert P.L. Stroucken, each of whom were members of the board of directors of Baxalta, have been appointed to the board of directors of Shire. No determination has been made as to any board committees on which Ms. Fosler and Mr. Stroucken may serve.
Ms. Fosler and Mr. Stroucken will receive compensation in accordance with Shires Remuneration Policy for non-executive directors. No shares will be granted to either Ms. Fosler or Mr. Stroucken on their appointment as a director, but 25% of the fees payable to each of Ms. Fosler and Mr. Stroucken under the Remuneration Policy will be payable in the form of shares.
Neither Ms. Fosler nor Mr. Stroucken is a party to a transaction with Shire which would require disclosure under Item 404(a) of Regulation S-K. Each of Ms. Fosler and Mr. Stroucken are eligible to participate in any compensation and benefit plans applicable to directors of Shire.
Item 7.01. Regulation FD Disclosure.
On June 3, 2016, Shire issued a press release announcing the consummation of the Merger. A copy of the press release is attached as Exhibit 99.1 hereto.
The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act ), or otherwise subject to the liabilities under that section and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing. In addition, Exhibit 99.1 contains statements intended as forward-looking statements that are subject to the cautionary statements about forward-looking statements set forth in such exhibit.
Although Shire, as a foreign private issuer, is not subject to Regulation FD, Shire has elected to furnish voluntarily the information herein under Item 7.01.
Item 9.01. Financial Statements and Exhibits.
(a) Financial Statements of Business Acquired.
The audited consolidated financial statements of Baxalta as of December 31, 2015 and 2014, and for the three years ended December 31, 2015, as well as the unaudited consolidated financial statements of Baxalta as of and for the three months ended March 31, 2016 and 2015, are filed herewith as Exhibit 99.2 and Exhibit 99.3 respectively, to this Current Report on Form 8-K.
(b) Pro Forma Financial Information.
Shire and Baxaltas unaudited pro forma condensed combined financial information as of and for the three months ended March 31, 2016 and the year ended December 31, 2015, is filed herewith as Exhibit 99.4 to this Current Report on Form 8-K.
(d) Exhibits.
Exhibit No. |
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Description |
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2.1 |
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Agreement and Plan of Merger, dated as of January 11, 2016, among Shire plc, BearTracks, Inc. and Baxalta Incorporated (incorporated herein by reference to Exhibit 2.1 to the Current Report on Form 8-K filed by Shire plc on January 11, 2016). |
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4.1 |
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Indenture between Baxalta Incorporated and The Bank of New York Mellon Trust Company, N.A., as Trustee, dated as of June 23, 2015 (incorporated herein by reference to Exhibit 4.1 to the Current Report on Form 8-K filed by Baxalta Incorporated on June 23, 2015). |
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4.2 |
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First Supplemental Indenture, to the Indenture dated as of June 23, 2015, between Baxalta Incorporated and The Bank of New York Mellon Trust Company, N.A., as Trustee, dated as of June 23, 2015 (incorporated herein by reference to Exhibit 4.2 to the Current Report on Form 8-K filed by Baxalta Incorporated on June 23, 2015). |
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4.3 |
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Second Supplemental Indenture, to the Indenture dated as of June 3, 2016, between Baxalta Incorporated, Shire plc and The Bank of New York Mellon Trust Company, N.A., as Trustee, dated as of June 3, 2016. |
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23.1 |
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Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm to Baxalta Incorporated. |
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99.1 |
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Press Release issued by Shire plc dated June 3, 2016 announcing the consummation of the merger. |
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99.2 |
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Audited Consolidated Financial Statements of Baxalta Incorporated as of and for the year ended December 31, 2015. |
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99.3 |
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Unaudited Consolidated Financial Statements of Baxalta Incorporated as of and for the three months ended March 31, 2016 and March 31, 2015. |
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99.4 |
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Unaudited Pro Forma Condensed Combined Financial Information of Shire plc and Baxalta Incorporated as of and for the three months ended March 31, 2016, and for the year ended December 31, 2015. |
EXHIBIT INDEX
Exhibit No. |
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Description |
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2.1 |
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Agreement and Plan of Merger, dated as of January 11, 2016, among Shire plc, BearTracks, Inc. and Baxalta Incorporated (incorporated herein by reference to Exhibit 2.1 to the Current Report on Form 8-K filed by Shire plc on January 11, 2016). |
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4.1 |
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Indenture between Baxalta Incorporated and The Bank of New York Mellon Trust Company, N.A., as Trustee, dated as of June 23, 2015 (incorporated herein by reference to Exhibit 4.1 of the Current Report on Form 8-K filed by Baxalta Incorporated on June 23, 2015). |
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4.2 |
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First Supplemental Indenture, to the Indenture dated as of June 23, 2015, between Baxalta Incorporated and The Bank of New York Mellon Trust Company, N.A., as Trustee, dated as of June 23, 2015 (incorporated herein by reference to Exhibit 4.2 of the Current Report on Form 8-K filed by Baxalta Incorporated on June 23, 2015). |
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4.3 |
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Second Supplemental Indenture, to the Indenture dated as of June 3, 2016, between Baxalta Incorporated, Shire plc and The Bank of New York Mellon Trust Company, N.A., as Trustee, dated as of June 3, 2016. |
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23.1 |
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Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm to Baxalta Incorporated. |
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99.1 |
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Press Release issued by Shire plc dated June 3, 2016 announcing the consummation of the merger. |
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99.2 |
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Audited Consolidated Financial Statements of Baxalta Incorporated as of and for the year ended December 31, 2015. |
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99.3 |
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Unaudited Consolidated Financial Statements of Baxalta Incorporated as of and for the three months ended March 31, 2016 and March 31, 2015. |
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99.4 |
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Unaudited Pro Forma Condensed Combined Financial Information of Shire plc and Baxalta Incorporated as of and for the three months ended March 31, 2016, and for the year ended December 31, 2015. |
Exhibit 4.3
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BAXALTA INCORPORATED,
as Issuer,
SHIRE PLC,
as Guarantor,
and
THE BANK OF NEW YORK MELLON TRUST COMPANY, N.A.,
as Trustee
SECOND SUPPLEMENTAL INDENTURE
DATED as of June 3, 2016
TO THE INDENTURE
DATED as of June 23, 2015
FLOATING RATE SENIOR NOTES DUE 2018
2.000% SENIOR NOTES DUE 2018
2.875% SENIOR NOTES DUE 2020
3.600% SENIOR NOTES DUE 2022
4.000% SENIOR NOTES DUE 2025
5.250% SENIOR NOTES DUE 2045
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Second Supplemental Indenture (this Second Supplemental Indenture ), dated as of June 3, 2016, among Shire plc, a Jersey public company (the Shire Parent Guarantor ), Baxalta Incorporated, a Delaware corporation (the Company ), and The Bank of New York Mellon Trust Company, N.A., as trustee under the Indenture referred to below (the Trustee ).
W I T N E S S E T H
WHEREAS, the Company has heretofore executed and delivered to the Trustee an indenture, dated as of June 23, 2015 (the Base Indenture ), amended, supplemented and modified by a supplemental indenture thereto, dated as of June 23, 2015 (the First Supplemental Indenture ), providing for the establishment of six series of securities known as the: (i) Floating Rate Senior Notes due 2018 (the Floating Rate Notes ), (ii) 2.000% Senior Notes due 2018 (the 2018 Notes ), (iii) 2.875% Senior Notes due 2020 (the 2020 Notes ), (iv) 3.600% Senior Notes due 2022 (the 2022 Notes ), (v) 4.000% Senior Notes due 2025 (the 2025 Notes ) and (vi) 5.250% Senior Notes due 2045 (the 2045 Notes, collectively with the 2018 Notes, the 2020 Notes, the 2022 Notes and the 2025 Notes, the Fixed Rate Notes, and the Fixed Rate Notes together with the Floating Rate Notes, the Securities ), the form, substance, terms, provisions and conditions of which were set forth in the Base Indenture and the First Supplemental Indenture (the Base Indenture, as amended, supplemented and modified by the First Supplemental Indenture or otherwise from time to time, shall be referred to herein as the Indenture );
WHEREAS, BearTracks, Inc., a wholly owned subsidiary of the Shire Parent Guarantor, merged with and into the Company, with the Company being the continuing Person under Section 12.02 of the Indenture (the Merger ), and the Company became a wholly owned subsidiary of the Shire Parent Guarantor;
WHEREAS, the Shire Parent Guarantor has agreed to execute and deliver to the Trustee this Second Supplemental Indenture pursuant to which the Shire Parent Guarantor shall fully and unconditionally guarantee all of the Companys obligations under the Securities and the Indenture on the terms and conditions set forth herein;
WHEREAS, pursuant to Section 11.01 of the Indenture, the parties hereto are authorized to execute and deliver this Second Supplemental Indenture and all conditions and requirements necessary to make this Second Supplemental Indenture a valid and binding agreement of the Company and the Shire Parent Guarantor have been duly performed and complied with; and
WHEREAS , the Company has furnished the Trustee with an Officers Certificate and an Opinion of Counsel, provided for under Sections 1.02 and 11.05 of the Indenture, stating that the execution of this Second Supplemental Indenture is authorized or permitted by the Indenture, that this Second Supplemental Indenture constitutes the valid and legally binding obligation of the Company and the Shire Parent Guarantor, subject to
certain customary exceptions stated therein, and that all conditions precedent to the execution and delivery of this Second Supplemental Indenture have been complied with; and the Company has delivered to the Trustee a Board Resolution authorizing the execution and delivery of this Second Supplemental Indenture;
NOW THEREFORE, in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto mutually covenant and agree for the benefit of each other and for the equal and ratable benefit of the Holders of the Securities as follows:
Section 1. Capitalized Terms . Capitalized terms used herein without definition shall have the meanings assigned to them in the Indenture.
Section 2. Agreement to Guarantee . The Shire Parent Guarantor hereby fully and unconditionally guarantees to the Holders from time to time of the Securities and to the Trustee the full and punctual payment when due, whether at stated maturity, by acceleration or otherwise, of the principal of, premium, if any, on and interest on each series of Securities and any other amounts due and payable with respect to the Securities under Section 7.07 of the Indenture (collectively, the Obligations ), according to the terms of the Securities and as set forth in the Indenture, as applicable, in each case subject to any applicable grace period or notice requirement or both (the Shire Parent Guarantee ). The Shire Parent Guarantee constitutes a guarantee of payment and not of collection.
Section 3. Guarantee Absolute . The Shire Parent Guarantor guarantees that the Obligations will be paid strictly in accordance with the terms of the Indenture and the Securities, regardless of any law, regulation or order now or hereafter in effect in any jurisdiction affecting any of such terms or the rights of Holders of the Securities with respect thereto. The liability of the Shire Parent Guarantor under the Shire Parent Guarantee shall be absolute and unconditional irrespective of:
(a) any lack of validity or enforceability of the Indenture, the Securities or any other agreement or instrument relating thereto;
(b) any change in the time, manner or place of payment of, or in any other term of, all or any of the Obligations, or any other amendment or waiver of or any consent to departure from the Indenture; or
(c) any other circumstance which might otherwise constitute a defense available to, or a discharge of, the Company or a guarantor (other than a defense of payment in full).
The obligation of the Shire Parent Guarantor to make any payment hereunder may be satisfied by causing the Company to make such payment.
Section 4. Termination of Shire Parent Guarantee . The Shire Parent Guarantee shall automatically terminate and be released, and the obligations of the Shire Parent Guarantor under the Shire Parent Guarantee shall cease to exist, with respect to a
particular series of Securities, upon payment in full of the Obligations with respect to such series of Securities.
Section 5. Reinstatement . The Shire Parent Guarantor hereby agrees that the Shire Parent Guarantee provided hereunder shall continue to be effective or be reinstated, as the case may be, if at any time, payment, or any part thereof, of any obligations or interest thereon is rescinded or must otherwise be restored by a Holder of the Securities to the Company upon the bankruptcy or insolvency of the Company.
Section 6. Waiver; Subrogation; Ranking .
(a) The Shire Parent Guarantor hereby waives all setoffs and counterclaims, notice of acceptance of this Shire Parent Guarantee, diligence, presentment, demand of payment, filing of claims with a court in the event of merger or insolvency or bankruptcy of the Company, any right to require a proceeding filed first against the Company, protest or notice with respect to the Securities or the indebtedness evidenced thereby and all demands whatsoever.
(b) The Shire Parent Guarantor shall be subrogated to all rights of the Trustee or the Holders of any Securities against the Company in respect of any amounts paid to the Trustee or such Holder by the Shire Parent Guarantor pursuant to the provisions of the Shire Parent Guarantee; provided, however, that the Shire Parent Guarantor waives any right to enforce, or to receive any payments arising out of, or based upon, such right of subrogation until all Obligations shall have been paid in full. The Shire Parent Guarantor acknowledges that it will receive direct and indirect benefits from the Merger and that the waiver set forth in this Section 5(b) is knowingly made in contemplation of such benefits.
(c) The Shire Parent Guarantor covenants and agrees that its obligation to make payments of the Obligations hereunder constitutes a senior unsecured, unsubordinated obligation of the Shire Parent Guarantor ranking pari passu with all existing and future senior indebtedness of the Shire Parent Guarantor and senior in right of payment to all existing and future subordinated indebtedness of the Shire Parent Guarantor.
Section 7. Remedies . The rights of the Holders of the Securities to enforce or institute any action under the Shire Parent Guarantee, or to direct the Trustee to do so, shall be subject to the terms of the Indenture (including Article VI thereof). The Shire Parent Guarantor hereby agrees that, in the event of a default in payment of principal (or premium, if any) or interest on any Securities whether at stated maturity, by acceleration or otherwise, legal proceedings may be instituted by the Trustee on behalf of, or by, the Holder of such Securities, subject to the terms and conditions set forth in the Indenture, directly against the Shire Parent Guarantor to enforce the Shire Parent Guarantee without first proceeding against the Company.
Section 8. Transfer of Interest . The Shire Parent Guarantee shall be binding upon the Shire Parent Guarantor and its successors and assigns, and shall inure to the benefit of and be enforceable by any Holder of Securities, the Trustee, and by their respective successors, transferees and assigns, pursuant to the terms hereof. The Shire
Parent Guarantee shall not be deemed to create any right in, or to be in whole or in part for the benefit of, any other person.
Section 9. Amendment . Notwithstanding anything to the contrary in the Indenture, with the consent (evidenced as provided in Section 9.01 of the Indenture) of the Holders of not less than a majority of the aggregate principal amount of the Outstanding Securities of any series affected, the Company and the Shire Parent Guarantor, when authorized by or pursuant to a resolution of its respective Board of Directors, and the Trustee may from time to time and at any time enter into an indenture or indentures supplemental to the Indenture (which shall, but only to the extent applicable, conform to the provisions of the Trust Indenture Act as shall be in force at the date of execution of such supplemental indenture or indentures) for the purpose, with respect to Securities of such series, of adding any provisions to or changing in any manner or eliminating any of the provisions of this Second Supplement Indenture (including, but not limited to, the Shire Parent Guarantee).
Section 10. Governing Law . THIS SECOND SUPPLEMENTAL INDENTURE SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK, WITHOUT REGARD TO THE PROVISIONS THEREOF RELATING TO CONFLICT OF LAWS.
Section 11. Waiver of Jersey Customary Rights. The Shire Parent Guarantor irrevocably and unconditionally abandons and waives any right which it may have at any time under the existing or future laws of Jersey:
(a) whether by virtue of the droit de discussion or otherwise to require that recourse be had by any Holder or the Trustee to the assets of any other person before any claim is enforced against the Shire Parent Guarantor in respect of the obligations assumed by it under this Second Supplemental Indenture or the Indenture; and
(b) whether by virtue of the droit de division or otherwise to require that any liability under any guarantee or indemnity contained in this Second Supplemental Indenture or the Indenture be divided or apportioned with any other person or reduced in any manner whatsoever.
Section 12. No Recourse Against Others . A director, officer, employee, stockholder, partner or other owner of the Shire Parent Guarantor, as such, shall not have any liability for any obligations of the Shire Parent Guarantor under this Second Supplemental Indenture, including the Shire Parent Guarantee, or for any claim based on, in respect of or by reason of such obligations or their creation.
Section 13. Separability . In case any provision in this Second Supplemental Indenture shall be invalid, illegal or unenforceable, (i) the validity, legality and enforceability of the remaining provisions hereof shall not in any way be affected or impaired thereby, it being intended that all of the provisions hereof shall be enforceable to the fullest extent permitted by law and (ii) the Company, the Shire Parent Guarantor and the Trustee shall endeavor in good faith negotiations to replace the invalid, illegal or
unenforceable provisions with valid provisions the economic effect of which comes as close as possible to that of the invalid, illegal or unenforceable provisions.
Section 14. Headings . The section headings of this Second Supplemental Indenture have been inserted for convenience of reference only, are not to be considered a part of this Second Supplemental Indenture and shall in no way modify or restrict any of the terms or provisions hereof.
Section 15. Notices, Etc., to the Shire Parent Guarantor . Any request, demand, authorization, direction, notice, consent, waiver or other action of Holders or other document provided or permitted by the Indenture to be made upon, given or furnished to, or filed with, the Shire Parent Guarantor by the Trustee or by any Holder shall be sufficient for every purpose hereunder (unless otherwise herein expressly provided) if in writing and mailed, first-class postage prepaid, or by any courier guaranteeing overnight delivery, to the Shire Parent Guarantor addressed to the address last furnished in writing to the Trustee by the Shire Parent Guarantor, or, if no such address has been furnished, to Attn: Bill Mordan, General Counsel, Shire plc, 5 Riverwalk, Citywest Business Campus, Dublin 24, Republic of Ireland. All requests and other communications shall be deemed to have been duly given three business days after being deposited in the mail if mailed postage prepaid; and on the next business day if timely delivered to an air courier guaranteeing overnight delivery.
Section 16. Trustee Not Responsible for Recitals . The Trustee makes no representations and shall not be responsible in any manner whatsoever for, or in respect of, the validity or sufficiency of this Second Supplemental Indenture or the Shire Parent Guarantee or for, or in respect of, the recitals contained herein, all of which recitals are made solely by the Company and the Shire Parent Guarantor, and the Trustee assumes no responsibility for the same. All rights, protections, privileges, indemnities and benefits granted or afforded to the Trustee under the Indenture shall be deemed incorporated herein by this reference and shall be deemed applicable to all actions taken, suffered or omitted by the Trustee under this Second Supplemental Indenture. The Trustee assumes no duties, responsibilities or liabilities by reason of this Second Supplemental Indenture other than as set forth in the Indenture.
Section 17. Counterparts . This Second Supplemental Indenture may be executed in any number of counterparts each of which shall be an original, but such counterparts shall together constitute but one and the same instrument. The exchange of copies of this Second Supplemental Indenture and of signature pages by facsimile or PDF transmission shall constitute effective execution and delivery of this Second Supplemental Indenture as to the parties hereto and may be used in lieu of the original Second Supplemental Indenture for all purposes. Signatures of the parties hereto transmitted by facsimile or PDF shall be deemed to be their original signatures for all purposes.
Section 18. Ratification of Indenture . The Indenture, as supplemented by this Second Supplemental Indenture, is in all respects ratified and confirmed, and this Second Supplemental Indenture shall be deemed part of the Indenture in the manner and to the extent herein and therein provided.
Section 19. Definitions. All terms used but not defined herein shall have the meanings ascribed to them in the Indenture.
[ Signature page follows ]
IN WITNESS WHEREOF, the parties hereto have caused this Second Supplemental Indenture to be duly executed and attested, all as of the date first above written.
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BAXALTA INCORPORATED |
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By: |
/s/ John F. Miller |
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Name: |
John F. Miller |
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Title: |
President and Treasurer |
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SHIRE PLC |
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By: |
/s/ Jeffrey Poulton |
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Name: |
Jeffrey Poulton |
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Title: |
Chief Financial Officer |
[ Signature Page to Second Supplemental Indenture to 2015 Indenture ]
IN WITNESS WHEREOF, the parties hereto have caused this Second Supplemental Indenture to be duly executed and attested, all as of the date first above written.
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THE BANK OF NEW YORK MELLON
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By: |
/s/ Lawrence M. Kusch |
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Name: |
Lawrence M. Kusch |
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Title: |
Vice President |
[ Signature Page to Second Supplemental Indenture to 2015 Indenture ]
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statement on Form S-4 (No. 333-209648) and Registration Statement on Form S-8 (Nos. 333-09168, 333-93543, 333-60952, 333-91552, 333- 111579, 333-129961, 333-129960, 333-111108, 333-202302, 333-175839, and 333-165137) of Shire plc of our report dated March 3, 2016 relating to the financial statements of Baxalta Incorporated, which appears in this Current Report on Form 8-K of Shire plc.
/s/ PricewaterhouseCoopers LLP
Chicago, Illinois
June 2, 2016
Exhibit 99.1
Press Release |
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www.shire.com |
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SHIRE COMPLETES COMBINATION WITH BAXALTA CREATING THE GLOBAL LEADER IN RARE DISEASES AND HIGHLY SPECIALIZED CONDITIONS
Combined company expected to deliver double-digit compound annual top-line growth with over $20 billion in annual revenues by 2020
Rare disease portfolio expected to immediately generate approximately 65% of total annual revenues
Expanded global reach and best-in-class products to enhance potential to help patients with significant unmet needs
Robust innovative pipeline expected to drive development of next-generation therapies
Dublin, Ireland June 3, 2016 Shire plc (LSE: SHP, NASDAQ: SHPG) today completed its previously announced combination with Baxalta Incorporated (NYSE: BXLT), creating the leading global biotechnology company focused on serving patients with rare diseases and other highly specialized conditions.
Through the combination, Shire expects to deliver double-digit compound annual top-line growth, with over $20 billion in annual projected revenue by 2020 and approximately 65% of total annual revenues being immediately generated by its rare disease products. Shire now has more than 50 programs in clinical development, with a balanced mix of early, mid and late-stage projects.
With over 22,000 employees across more than 100 countries, Shires expanded global reach and best-in-class products offer the potential to help even more patients around the world with significant unmet needs.
Shire Chief Executive Officer Flemming Ornskov, M.D., M.P.H., commented: Upon the completion of our combination with Baxalta, Shire is now the global leader in rare diseases, with the number one rare diseases platform based on both revenue and pipeline programs. With our multiple high-value franchises, each with best-in-class products and a robust innovative portfolio, we further extend our capabilities for innovation and sustainable growth with patients at the center of everything we do.
Dr. Ornskov continued, We have made impressive progress on integration planning since announcing the combination, moving much faster than other transactions of similar size based on benchmarks, to create certainty for our employees and to better serve our patients and customers going forward. As we launch our combined company today, we have a talented and experienced extended leadership team in place to guide the organization in achieving our goals. Working together, the possibilities are tremendous for our patients, healthcare partners and, importantly, our people, with opportunity for additional value creation for our shareholders.
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
As a result of the completion of the combination:
· The appointment of Gail D. Fosler and Albert P.L. Stroucken to the Shire Board of Directors, announced on April 18, 2016, is effective;
· Baxalta shareholders will receive a combination of $18.00 in cash and 0.1482 Shire ADSs for each Baxalta share (or 0.4446 of a Shire ordinary share if the Baxalta shareholder validly elected to receive ordinary shares);
· Baxalta became an indirect wholly-owned subsidiary of Shire; and
· Shire will provide a full and unconditional guarantee of Baxaltas obligations to the holders of Baxaltas outstanding senior notes.
The efficient operating structure of the combined company is expected to yield annual operating cost synergies of at least $500 million within the first three years post-closing. Further, Shire expects to generate additional revenue synergies and a combined non-GAAP effective tax rate of 16-17% by 2017. The combination is expected to be accretive to non-GAAP diluted EPS in 2017, the first calendar year of ownership, and beyond, with an attractive ROIC that will exceed Shires cost of capital in 2020.
Additional details on the strength of the combined company, including 2016 financial guidance and updated 3-year synergy targets, will be provided during Shires second quarter earnings conference call scheduled for August 2, 2016. Shire will also be hosting an Investor Day in New York on November 10, 2016, where it will share highlights of the R&D portfolio and Baxalta commercial business.
More information is also available at Shire.com.
About Shire
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
www.shire.com
FOR FURTHER INFORMATION PLEASE CONTACT:
FOR SHIRE
Investor Relations |
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Sarah Elton-Farr |
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seltonfarr@shire.com |
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+44 1256 894157 |
Robert Coates |
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rcoates@shire.com |
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+44 1256 894874 |
Ian Karp |
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ikarp@shire.com |
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+1 781 482 9018 |
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Media |
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Gwen Fisher |
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gfisher@shire.com |
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+1 781 482 9649 |
Geoffrey Mogilner |
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geoffrey.mogilner@shire.com |
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+1 224 940 8619 |
Brooke Clarke |
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brclarke@shire.com |
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+44 1256 894829 |
Forward-Looking Statements
Statements included herein that are not historical facts, including without limitation statements concerning the financial and strategic benefits of the combination with Baxalta, our 20x20 ambition that targets $20 billion in combined product sales by 2020, as well as other targets for future financial results, capital structure, performance and sustainability of the combined company, the combined companys future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shires results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
· disruption from the acquisition and integration of Baxalta may make it more difficult to conduct business as usual or maintain relationships with patients, physicians, employees or suppliers;
· the company may not achieve some or all of the anticipated benefits of Baxaltas spin-off from Baxter International, Inc. (Baxter) and the acquisition may have an adverse impact on Baxaltas existing arrangements with Baxter, including those related to transition, manufacturing and supply services and tax matters;
· the failure to achieve the strategic objectives with respect to the acquisition of Baxalta may adversely affect the companys financial condition and results of operations;
· products and product candidates may not achieve commercial success;
· product sales from ADDERALL XR and INTUNIV are subject to generic competition;
· the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for the companys products may affect future revenues, financial condition and results of operations, particularly if there is pressure on pricing of products to treat rare diseases;
· supply chain or manufacturing disruptions may result in declines in revenue for affected products and commercial traction from competitors; regulatory actions associated with product approvals or changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
· the successful development of products in various stages of research and development is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
· the actions of certain customers could affect the companys ability to sell or market products profitably, and fluctuations in buying or distribution patterns by such customers can adversely affect the companys revenues, financial condition or results of operations;
· investigations or enforcement action by regulatory authorities or law enforcement agencies relating to the companys activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
· adverse outcomes in legal matters, tax audits and other disputes, including the companys ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the companys revenues, financial condition or results of operations;
· Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect the companys ability to attract and/or retain the highly skilled personnel needed to meet its strategic objectives;
· failure to achieve the strategic objectives with respect to Shires acquisition of NPS Pharmaceuticals Inc. or Dyax Corp. (Dyax) may adversely affect the companys financial condition and results of operations;
· the company is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on the companys revenues, financial condition or results of operations;
· the company may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other business partners;
· difficulties in integrating Dyax or Baxalta into Shire may lead to the company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all; and
other risks and uncertainties detailed from time to time in Shires, Dyaxs or Baxaltas filings with the Securities and Exchange Commission, including those risks outlined in ITEM 1A: Risk Factors in Shires and Baxaltas Annual Reports on Form 10-K for the year ended December 31, 2015.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Exhibit 99.2
INDEX TO FINANCIAL STATEMENTS
For the year ended December 31, 2015
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AUDITED COMBINED FINANCIAL STATEMENTS: |
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Report of Independent Registered Public Accounting Firm on Financial Statements |
2 |
Consolidated and Combined Balance Sheets |
3 |
Consolidated and Combined Statements of Income |
4 |
Consolidated and Combined Statements of Comprehensive Income |
5 |
Consolidated and Combined Statements of Cash Flows |
6 |
Consolidated and Combined Statements of Changes in Equity |
7 |
Notes to Consolidated and Combined Financial Statements |
8 |
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of Baxalta Incorporated:
In our opinion, the accompanying consolidated and combined balance sheets and the related consolidated and combined statements of income, comprehensive income, changes in equity and cash flows present fairly, in all material respects, the financial position of Baxalta Incorporated and its subsidiaries at December 31, 2015 and 2014, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2015 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
As discussed in Note 14 to the consolidated and combined financial statements, the Company changed the manner in which it accounts for the classification of deferred income tax balances in 2015.
/s/ PricewaterhouseCoopers LLP |
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Chicago, Illinois |
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March 3, 2016 |
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BAXALTA INCORPORATED
CONSOLIDATED AND COMBINED BALANCE SHEETS
as of December 31 (in millions, except share data) |
|
2015 |
|
2014 |
|
||
Assets |
|
|
|
|
|
||
Current Assets: |
|
|
|
|
|
||
Cash and equivalents |
|
$ |
1,001 |
|
$ |
|
|
Accounts and other current receivables, net |
|
914 |
|
960 |
|
||
Inventories |
|
2,173 |
|
1,960 |
|
||
Prepaid expenses and other |
|
620 |
|
173 |
|
||
|
|
|
|
|
|
||
Total current assets |
|
4,708 |
|
3,093 |
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||
|
|
|
|
|
|
||
Property, plant and equipment, net |
|
5,034 |
|
4,192 |
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||
Goodwill |
|
829 |
|
565 |
|
||
Other intangible assets, net |
|
1,295 |
|
459 |
|
||
Deferred income taxes |
|
214 |
|
43 |
|
||
Other long-term assets |
|
249 |
|
231 |
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||
|
|
|
|
|
|
||
Total assets |
|
$ |
12,329 |
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$ |
8,583 |
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|
|
|
|
|
|
||
Liabilities and Equity |
|
|
|
|
|
||
Current Liabilities: |
|
|
|
|
|
||
Current maturities of long-term debt and lease obligations |
|
$ |
3 |
|
$ |
|
|
Accounts payable |
|
706 |
|
484 |
|
||
Accrued liabilities |
|
1,202 |
|
1,156 |
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||
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|
|
|
|
|
||
Total current liabilities |
|
1,911 |
|
1,640 |
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||
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|
|
|
|
|
||
Long-term debt and capital lease obligations |
|
5,265 |
|
275 |
|
||
Deferred income taxes |
|
181 |
|
72 |
|
||
Other long-term liabilities |
|
1,048 |
|
849 |
|
||
Commitments and contingencies |
|
|
|
|
|
||
Equity: |
|
|
|
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|
||
Common stock, $0.01 par value (shares authorized of 2,500,000,000 at December 31, 2015 and zero at December 31, 2014, shares issued and outstanding of 679,287,500 at December 31, 2015 and zero at December 31, 2014) |
|
7 |
|
|
|
||
Additional paid-in capital |
|
4,103 |
|
|
|
||
Net parent company investment |
|
|
|
6,180 |
|
||
Retained earnings |
|
309 |
|
|
|
||
Accumulated other comprehensive loss |
|
(495 |
) |
(433 |
) |
||
|
|
|
|
|
|
||
Total equity |
|
3,924 |
|
5,747 |
|
||
|
|
|
|
|
|
||
Total liabilities and equity |
|
$ |
12,329 |
|
$ |
8,583 |
|
The accompanying notes are an integral part of these consolidated and combined financial statements.
BAXALTA INCORPORATED
CONSOLIDATED AND COMBINED STATEMENTS OF INCOME
years ended December 31 (in millions, except per share amounts) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Net sales |
|
$ |
6,148 |
|
$ |
5,952 |
|
$ |
5,555 |
|
Cost of sales |
|
2,386 |
|
2,443 |
|
2,329 |
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|||
|
|
|
|
|
|
|
|
|||
Gross margin |
|
3,762 |
|
3,509 |
|
3,226 |
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|||
|
|
|
|
|
|
|
|
|||
Selling, general and administrative expenses |
|
1,442 |
|
1,053 |
|
1,017 |
|
|||
Research and development expenses |
|
1,176 |
|
820 |
|
595 |
|
|||
Net interest expense |
|
48 |
|
|
|
|
|
|||
Other (income) expense, net |
|
(102 |
) |
104 |
|
1 |
|
|||
|
|
|
|
|
|
|
|
|||
Income from continuing operations before income taxes |
|
1,198 |
|
1,532 |
|
1,613 |
|
|||
Income tax expense |
|
270 |
|
346 |
|
325 |
|
|||
|
|
|
|
|
|
|
|
|||
Net income from continuing operations |
|
928 |
|
1,186 |
|
1,288 |
|
|||
Income from discontinued operations, net of tax |
|
28 |
|
551 |
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Net income |
|
$ |
956 |
|
$ |
1,737 |
|
$ |
1,288 |
|
|
|
|
|
|
|
|
|
|||
Income from continuing operations per common share |
|
|
|
|
|
|
|
|||
Basic |
|
$ |
1.37 |
|
$ |
1.75 |
|
$ |
1.90 |
|
Diluted |
|
$ |
1.36 |
|
$ |
1.74 |
|
$ |
1.89 |
|
Income from discontinued operations per common share |
|
|
|
|
|
|
|
|||
Basic |
|
$ |
0.04 |
|
$ |
0.82 |
|
$ |
|
|
Diluted |
|
$ |
0.04 |
|
$ |
0.81 |
|
$ |
|
|
Net income per common share |
|
|
|
|
|
|
|
|||
Basic |
|
$ |
1.41 |
|
$ |
2.57 |
|
$ |
1.90 |
|
Diluted |
|
$ |
1.40 |
|
$ |
2.55 |
|
$ |
1.89 |
|
Weighted-average number of common shares outstanding |
|
|
|
|
|
|
|
|||
Basic |
|
677 |
|
676 |
|
676 |
|
|||
Diluted |
|
683 |
|
681 |
|
681 |
|
The accompanying notes are an integral part of these consolidated and combined financial statements.
BAXALTA INCORPORATED
CONSOLIDATED AND COMBINED STATEMENTS OF COMPREHENSIVE INCOME
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Net income |
|
$ |
956 |
|
$ |
1,737 |
|
$ |
1,288 |
|
Other comprehensive (loss) income, net of tax: |
|
|
|
|
|
|
|
|||
Currency translation adjustments, net of tax benefit (expense) of $0 in 2015, $28 in 2014, and ($14) in 2013 |
|
(362 |
) |
(387 |
) |
72 |
|
|||
Pension and other employee benefits, net of tax benefit (expense) of ($14) in 2015, $5 in 2014 and ($2) in 2013 |
|
11 |
|
(1 |
) |
(7 |
) |
|||
Available-for-sale securities, net of tax benefit (expense) of ($6) in 2015, $2 in 2014, and ($3) in 2013 |
|
1 |
|
20 |
|
(15 |
) |
|||
Hedging activities, net of tax benefit (expense) of ($4) in 2015 and less than $1 in 2014 |
|
6 |
|
(1 |
) |
|
|
|||
|
|
|
|
|
|
|
|
|||
Total other comprehensive (loss) income, net of tax |
|
(344 |
) |
(369 |
) |
50 |
|
|||
|
|
|
|
|
|
|
|
|||
Comprehensive income |
|
$ |
612 |
|
$ |
1,368 |
|
$ |
1,338 |
|
The accompanying notes are an integral part of these consolidated and combined financial statements.
BAXALTA INCORPORATED
CONSOLIDATED AND COMBINED STATEMENTS OF CASH FLOWS
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Cash flows from operations |
|
|
|
|
|
|
|
|||
Net income |
|
$ |
956 |
|
$ |
1,737 |
|
$ |
1,288 |
|
Adjustments |
|
|
|
|
|
|
|
|||
Depreciation and amortization |
|
257 |
|
206 |
|
184 |
|
|||
Deferred income taxes |
|
(65 |
) |
68 |
|
(43 |
) |
|||
Share-based compensation expense |
|
62 |
|
32 |
|
27 |
|
|||
Excess tax benefits from share-based compensation |
|
(7 |
) |
(9 |
) |
(13 |
) |
|||
Business optimization (benefits) charges, net |
|
(12 |
) |
33 |
|
133 |
|
|||
Gain on sale of discontinued operations |
|
(38 |
) |
(466 |
) |
|
|
|||
Net periodic pension benefit and OPEB cost |
|
69 |
|
52 |
|
60 |
|
|||
Change in fair value of contingent payment liabilities |
|
(97 |
) |
124 |
|
18 |
|
|||
IPR&D impairment charge |
|
81 |
|
|
|
|
|
|||
Other |
|
61 |
|
116 |
|
47 |
|
|||
Changes in balance sheet items |
|
|
|
|
|
|
|
|||
Accounts and other current receivables, net |
|
(285 |
) |
(75 |
) |
(51 |
) |
|||
Inventories |
|
(429 |
) |
(282 |
) |
(261 |
) |
|||
Accounts payable |
|
189 |
|
127 |
|
45 |
|
|||
Accrued liabilities |
|
73 |
|
(195 |
) |
202 |
|
|||
Due to/from Baxter International Inc |
|
86 |
|
|
|
|
|
|||
Business optimization payments |
|
(19 |
) |
(37 |
) |
(31 |
) |
|||
Other |
|
(83 |
) |
(58 |
) |
(57 |
) |
|||
|
|
|
|
|
|
|
|
|||
Net cash provided from operations |
|
$ |
799 |
|
$ |
1,373 |
|
$ |
1,548 |
|
|
|
|
|
|
|
|
|
|||
Cash flows from investing activities |
|
|
|
|
|
|
|
|||
Capital expenditures |
|
(1,216 |
) |
(970 |
) |
(797 |
) |
|||
Acquisitions, net of cash acquired |
|
(1,163 |
) |
(185 |
) |
(111 |
) |
|||
Divestiture of vaccines business |
|
46 |
|
640 |
|
|
|
|||
Other investing activities |
|
40 |
|
14 |
|
(69 |
) |
|||
|
|
|
|
|
|
|
|
|||
Net cash used for investing activities |
|
$ |
(2,293 |
) |
$ |
(501 |
) |
$ |
(977 |
) |
|
|
|
|
|
|
|
|
|||
Cash flows from financing activities |
|
|
|
|
|
|
|
|||
Net proceeds from issuance of long-term debt |
|
4,945 |
|
|
|
|
|
|||
Payments of obligations |
|
(4 |
) |
|
|
|
|
|||
Cash dividends on common stock |
|
(47 |
) |
|
|
|
|
|||
Net transactions with Baxter International Inc. |
|
(2,455 |
) |
(856 |
) |
(571 |
) |
|||
Proceeds and excess tax benefits related to share-based compensation |
|
64 |
|
|
|
|
|
|||
Other financing activities |
|
(11 |
) |
(16 |
) |
|
|
|||
|
|
|
|
|
|
|
|
|||
Net cash provided from (used for) financing activities |
|
$ |
2,492 |
|
$ |
(872 |
) |
$ |
(571 |
) |
|
|
|
|
|
|
|
|
|||
Effect of foreign exchange rate changes on cash and equivalents |
|
3 |
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Change in cash and equivalents |
|
1,001 |
|
|
|
|
|
|||
Cash and equivalents at beginning of period |
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Cash and equivalents at end of period |
|
$ |
1,001 |
|
$ |
|
|
$ |
|
|
The accompanying notes are an integral part of these consolidated and combined financial statements.
BAXALTA INCORPORATED
CONSOLIDATED AND COMBINED STATEMENTS OF CHANGES IN EQUITY
|
|
Common Stock |
|
Additional
|
|
Net Parent
|
|
Retained |
|
|
|
Total |
|
||||||||
(in millions, except share data) |
|
Shares |
|
Amount |
|
Capital |
|
Investment |
|
Earnings |
|
AOCI |
|
Equity |
|
||||||
Balance as of December 31, 2012 |
|
|
|
$ |
|
|
$ |
|
|
$ |
4,465 |
|
$ |
|
|
$ |
(114 |
) |
$ |
4,351 |
|
Net income |
|
|
|
|
|
|
|
1,288 |
|
|
|
|
|
1,288 |
|
||||||
Net transfers to Baxter International Inc. |
|
|
|
|
|
|
|
(510 |
) |
|
|
|
|
(510 |
) |
||||||
Other comprehensive loss, net of tax |
|
|
|
|
|
|
|
|
|
|
|
50 |
|
50 |
|
||||||
Balance as of December 31, 2013 |
|
|
|
$ |
|
|
$ |
|
|
$ |
5,243 |
|
$ |
|
|
$ |
(64 |
) |
$ |
5,179 |
|
Balance as of December 31, 2013 |
|
|
|
$ |
|
|
$ |
|
|
$ |
5,243 |
|
$ |
|
|
$ |
(64 |
) |
$ |
5,179 |
|
Net income |
|
|
|
|
|
|
|
1,737 |
|
|
|
|
|
1,737 |
|
||||||
Net transfers from Baxter International Inc. |
|
|
|
|
|
|
|
(800 |
) |
|
|
|
|
(800 |
) |
||||||
Other comprehensive loss, net of tax |
|
|
|
|
|
|
|
|
|
|
|
(369 |
) |
(369 |
) |
||||||
Balance as of December 31, 2014 |
|
|
|
$ |
|
|
$ |
|
|
$ |
6,180 |
|
$ |
|
|
$ |
(433 |
) |
$ |
5,747 |
|
Balance as of December 31, 2014 |
|
|
|
$ |
|
|
|
|
$ |
6,180 |
|
$ |
|
|
$ |
(433 |
) |
$ |
5,747 |
|
|
Net income |
|
|
|
|
|
|
|
552 |
|
404 |
|
|
|
956 |
|
||||||
Net transfers to Baxter International Inc. |
|
|
|
|
|
|
|
(2,374 |
) |
|
|
|
|
(2,374 |
) |
||||||
Separation-related adjustments |
|
|
|
|
|
(36 |
) |
(318 |
) |
|
|
282 |
|
(72 |
) |
||||||
Reclassification of net parent company investment to additional paid-in capital |
|
|
|
|
|
4,040 |
|
(4,040 |
) |
|
|
|
|
|
|
||||||
Issuance of common stock upon separation |
|
676,424,202 |
|
7 |
|
(7 |
) |
|
|
|
|
|
|
|
|
||||||
Share-based compensation expense |
|
|
|
|
|
43 |
|
|
|
|
|
|
|
43 |
|
||||||
Shares issued under employee benefit plans and other |
|
2,863,298 |
|
|
|
63 |
|
|
|
|
|
|
|
63 |
|
||||||
Other comprehensive loss, net of tax |
|
|
|
|
|
|
|
|
|
|
|
(344 |
) |
(344 |
) |
||||||
Dividends declared ($0.14 per share) |
|
|
|
|
|
|
|
|
|
(95 |
) |
|
|
(95 |
) |
||||||
Balance as of December 31, 2015 |
|
679,287,500 |
|
$ |
7 |
|
$ |
4,103 |
|
$ |
|
|
$ |
309 |
|
$ |
(495 |
) |
$ |
3,924 |
|
The accompanying notes are an integral part of these consolidated and combined financial statements.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS
NOTE 1 NATURE OF BUSINESS AND BASIS OF PREPARATION
Baxalta Incorporated, together with its subsidiaries, (Baxalta or the company) is a global innovative biopharmaceutical leader with a sustainable portfolio of differentiated therapies that seek to address unmet medical needs across many disease areas, including hematology, immunology and oncology.
Separation from Baxter
Baxalta was incorporated in Delaware on September 8, 2014. The company separated from Baxter International Inc. (Baxter) on July 1, 2015 (the separation), becoming an independent company as a result of a pro rata distribution by Baxter of 80.5% of Baxaltas common stock to Baxters shareholders. Baxter retained an approximate 19.5% ownership stake in Baxalta immediately following this distribution. Baxters Board of Directors approved the distribution of its shares of Baxalta on June 5, 2015. Baxaltas Registration Statement was declared effective by the U.S. Securities and Exchange Commission (SEC) on June 9, 2015. On July 1, 2015, Baxters shareholders of record as of the close of business on June 17, 2015 received one share of Baxalta common stock for every one share of Baxters common stock held as of the record date. Baxalta common stock began trading regular way under the ticker symbol BXLT on the New York Stock Exchange on July 1, 2015.
In January 2016, Baxter exchanged a portion of its retained stake in Baxalta common stock for indebtedness of Baxter held by a third party. The shares of Baxalta common stock exchanged were then sold in a secondary public offering pursuant to a registration statement filed by Baxalta. Immediately following this transaction, Baxter held approximately 13.9% of Baxaltas total shares outstanding.
Merger Agreement with Shire
In January 2016, the company announced that it had reached an agreement (merger agreement) with Shire plc (Shire) under which Shire would acquire Baxalta, forming a global leader in rare diseases. Under the terms of the agreement, Baxalta shareholders will receive $18.00 in cash and 0.1482 Shire American Depository Shares (ADS) per each Baxalta share. The transaction has been approved by the boards of directors of both Shire and Baxalta. Closing of the transaction is subject to approval by Baxalta and Shire shareholders, certain regulatory approvals, receipt of certain tax opinions and other customary closing conditions. The transaction is expected to close in mid-2016.
The merger agreement provides for certain termination rights for both Shire and Baxalta. Upon termination of the merger agreement under certain specified circumstances, Baxalta may be required to disburse to Shire a termination fee of $369 million and Shire may be required to pay the company a termination fee of $369 million. In addition, if the merger agreement is terminated under certain specified circumstances following the receipt of an acquisition proposal by Baxalta, Baxalta may be required to reimburse Shire for transaction expenses up to $110 million (which expenses would be credited against any termination fee subsequently disbursed by Baxalta), and if the merger agreement is terminated under certain specified circumstances following the receipt of an acquisition proposal by Shire, Shire may be required to reimburse Baxalta for transaction expenses up to $65 million (which expenses would be credited against any termination fee subsequently payable by Shire).
Nature of Business
The principal business of the company is the development, manufacture and marketing of a diverse portfolio of treatments for hemophilia and other bleeding disorders, immune deficiencies, alpha-1 antitrypsin deficiency, burns and shock, and other chronic and acute medical conditions, as well as
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 1 NATURE OF BUSINESS AND BASIS OF PREPARATION (Continued)
oncology treatments for acute lymphoblastic leukemia. The company is also investing in emerging technology platforms, including gene therapy and biosimilars.
The companys business strategy is aimed at improving diagnosis, treatment and standards of care across a wide range of bleeding disorders and other rare chronic and acute medical conditions, capitalizing on the companys differentiated portfolio, ensuring the sustainability of supply to meet growing demand for therapies across core disease areas, and accelerating innovation by developing and launching new treatments while leveraging its expertise into new emerging therapeutics through acquisitions of and collaborations with others.
The companys primary manufacturing facilities are located in the United States, Austria, Switzerland, Singapore and Belgium. The company distributes its products through its own direct sales force, independent distributors and drug wholesalers, and sells to customers throughout the world.
Basis of Preparation
The accompanying consolidated and combined financial statements reflect the consolidated financial position and consolidated results of operations of the company as an independent, publicly-traded company for periods after the July 1, 2015 separation. The consolidated and combined financial statements reflect the combined financial position and combined results of operations of the company as a combined reporting entity of Baxter for periods prior to the separation.
During 2015, the company recorded certain separation-related adjustments in its statement of changes in equity, resulting in a net $72 million decrease in equity. The adjustments primarily related to differences in the amount of assets, liabilities and accumulated other comprehensive income (AOCI) transferred to Baxalta (transferred items) and the amount of the transferred items reported in the companys combined balance sheet as of June 30, 2015. In addition, the company reported separation-related adjustments for deferred hedging gains and pension losses reported in AOCI that were assumed during the three months ended June 30, 2015. Additional separation-related adjustments could be recorded in future periods.
Prior to the separation, the combined financial statements were prepared on a standalone basis and were derived from Baxters consolidated financial statements and accounting records as if the former biopharmaceuticals business of Baxter had been part of Baxalta. The combined financial statements reflected the companys financial position, results of operations and cash flows as the business was operated as part of Baxter prior to the separation, in conformity with generally accepted accounting principles in the United States (GAAP).
Prior to the separation, the combined financial statements included the attribution of certain assets and liabilities that were historically held at the Baxter corporate level but which were specifically identifiable or attributable to the company. All intercompany transactions and accounts within the company were eliminated. All transactions between the company and Baxter were considered to be effectively settled in the combined financial statements at the time the transaction was recorded. The total net effect of the settlement of the transactions with Baxter were reflected in the combined statements of cash flows in periods prior to the separation as a financing activity and in the combined balance sheet as net parent company investment.
Prior to the separation, the combined financial statements included an allocation of expenses related to certain Baxter corporate functions, including senior management, legal, human resources,
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 1 NATURE OF BUSINESS AND BASIS OF PREPARATION (Continued)
finance, treasury, information technology, and quality assurance. These expenses were allocated to the company based on direct usage or benefit where specifically identifiable, with the remainder allocated primarily on a pro rata basis of revenue, headcount, square footage, or other measures. The company considers the expense methodology and results to be reasonable for all periods prior to the separation. However, the allocations may not be indicative of the actual expense that would have been incurred had the company operated as an independent, publicly traded company for the periods prior to the separation.
In periods prior to the separation, Baxaltas employees participated in various benefit and share-based compensation plans maintained by Baxter. A portion of the cost of those plans was included in the companys financial statements. However, the combined balance sheets in periods prior to the separation did not include any equity related to share-based compensation plans. As of and prior to December 31, 2014, the companys combined balance sheets did not include net pension obligations, with the exception of those related to certain plans in Austria. Refer to Note 12 and Note 15 for further description of the accounting for retirement and other benefit programs and share-based compensation, respectively.
Prior to the separation, the companys equity balance represented the excess of total assets over total liabilities, including the due to/from balances between the company and Baxter (net parent company investment) and AOCI. Net parent company investment was primarily impacted by distributions and contributions to or from Baxter, which were the result of treasury activities and net funding provided by or distributed to Baxter, including a $4 billion cash distribution made by Baxalta to Baxter in June 2015. In connection with the separation, the companys net parent company investment balance was reclassified to additional paid-in capital.
NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of the financial statements in conformity with GAAP requires the company to make estimates and assumptions that affect reported amounts and related disclosures. Actual results could differ from these estimates.
Reclassifications
Certain reclassifications have been made to the prior period financial statements to conform to the current period presentation. These reclassifications had no effect on previously reported results of operations or shareholders equity.
Revenue Recognition
The company recognizes revenues from product sales when earned. Specifically, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred, the price is fixed or determinable, and collectability is reasonably assured. For product sales, revenue is not recognized until title and risk of loss have transferred to the customer. The shipping terms for the majority of the companys revenue arrangements indicate title and risk of loss pass at delivery. Provisions for rebates, chargebacks to wholesalers and distributors, returns, and discounts are provided for at the time the related sales are recorded, and are reflected as a reduction of sales.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Cash and Equivalents
Cash and equivalents include cash, time deposits, certificate of deposits and money market funds with an original maturity of three months or less.
Accounts Receivable and Allowance for Doubtful Accounts
In the normal course of business, the company provides credit to its customers and maintains reserves for potential credit losses. The companys allowance for doubtful accounts was $11 million, $20 million and $21 million as of December 31, 2015, 2014 and 2013, respectively. The decrease in the allowance for doubtful accounts from December 31, 2014 to December 31, 2015 was primarily due to reserves in countries with operations that have not yet transferred to Baxalta, which were reported in the companys combined reserves as of December 31, 2014 but not in its consolidated reserves as of December 31, 2015. Refer to Note 17 for additional information regarding operations in countries that have not yet transferred from Baxter to Baxalta.
Inventories
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
||
Raw materials |
|
$ |
589 |
|
$ |
524 |
|
Work in process |
|
1,021 |
|
976 |
|
||
Finished goods |
|
563 |
|
460 |
|
||
|
|
|
|
|
|
||
Total inventories |
|
$ |
2,173 |
|
$ |
1,960 |
|
Inventories are stated at the lower of cost (first-in, first-out method) or market value. Market value for raw materials is based on replacement costs, and market value for work in process and finished goods is based on net realizable value.
Property, Plant and Equipment, Net
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
||
Land |
|
$ |
105 |
|
$ |
105 |
|
Buildings and leasehold improvements |
|
1,433 |
|
1,260 |
|
||
Machinery and equipment |
|
2,311 |
|
2,259 |
|
||
Construction in progress |
|
2,718 |
|
2,109 |
|
||
|
|
|
|
|
|
||
Total property, plant and equipment, at cost |
|
6,567 |
|
5,733 |
|
||
Accumulated depreciation |
|
(1,533 |
) |
(1,541 |
) |
||
|
|
|
|
|
|
||
Property, plant and equipment (PP&E), net |
|
$ |
5,034 |
|
$ |
4,192 |
|
Depreciation expense is calculated using the straight-line method over the estimated useful lives of the related assets, which range from 20 to 50 years for buildings and improvements and from three to 15 years for machinery and equipment. Leasehold improvements are amortized over the life of the related facility lease (including any renewal periods, if appropriate) or the asset, whichever is shorter. Machinery and equipment includes capitalized software costs, which are amortized on a straight-line
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
basis over the estimated useful lives of the software. The companys policy is to place construction in process assets in service and begin depreciation when the asset is ready for its intended use.
Depreciation expense was $204 million in 2015, $189 million in 2014, and $168 million in 2013. The companys accumulated depreciation balance did not significantly change from December 31, 2014 to December 31, 2015. Increases resulting from depreciation expense were offset primarily by disposals of assets that had previously been fully depreciated or impaired and cumulative translation adjustments (CTA).
Gross assets recorded under capital leases and reported in buildings and leasehold improvements and construction in progress were $339 million and $283 million as of December 31, 2015 and December 31, 2014, respectively, and associated accumulated depreciation was $7 million and $3 million as of December 31, 2015 and December 31, 2014, respectively.
Acquisitions
Results of operations of acquired companies are included in the companys results of operations as of the respective acquisition dates. The purchase price of each acquisition is allocated to the net assets acquired based on estimates of their fair values at the date of the acquisition. Any purchase price in excess of these net assets is recorded as goodwill. The allocation of purchase price in certain cases may be subject to revision based on the final determination of fair values during the measurement period, which may be up to one year from the acquisition date.
Contingent consideration is recognized at the estimated fair value on the acquisition date. Subsequent changes to the fair value of contingent considerations are recognized in earnings.
Research and Development
Research and development (R&D) costs are expensed as incurred. Pre-regulatory approval contingent milestone obligations to counterparties in collaborative arrangements are expensed when the milestone is achieved. Payments made to counterparties on or after regulatory approval are capitalized and amortized over the remaining useful life of the related product. Amounts capitalized for such payments are included in other intangible assets, net of accumulated amortization.
Acquired in-process R&D (IPR&D) is the value assigned to products under development acquired in a business combination which have not received regulatory approval and have no alternative future use. Acquired IPR&D is capitalized as an indefinite-lived intangible asset. Development costs incurred after the acquisition date are expensed as incurred. Upon receipt of regulatory approval of the related product, the indefinite-lived intangible asset is accounted for as a finite-lived intangible asset and generally amortized on a straight-line basis over the estimated economic life of the related product, subject to annual impairment reviews as discussed below. If the R&D project is abandoned, the indefinite-lived asset is charged to expense.
Collaborative Arrangements
The company enters into collaborative arrangements in the normal course of business. These collaborative arrangements take a number of forms and structures, and are designed to enhance and expedite long-term sales and profitability growth. These arrangements generally provide that the company obtain commercialization rights to a product under development. The agreements often
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
require the company make upfront payments and include additional contingent milestone payments relating to the achievement of specified development, regulatory and commercial milestones, as well as royalty payments. The company may also be responsible for other on-going costs associated with the arrangements, including R&D cost reimbursements to the counterparty.
Royalty payments are expensed as cost of sales when they become due and payable. Any purchases of product from the partner during the development stage are expensed as R&D, while such purchases during the commercialization phase are capitalized as inventory and recognized as cost of sales when the related finished products are sold. The company presents upfront payments to collaboration partners as investing activities and milestone payments as operating activities in the consolidated and combined statements of cash flows.
Business Optimization Charges
The company records liabilities for costs associated with exit or disposal activities in the period in which the liability is incurred. Employee termination costs are primarily recorded when actions are probable and estimable. Costs for one-time termination benefits in which the employee is required to render service until termination in order to receive the benefits are recognized ratably over the future service period.
Goodwill
Goodwill is not amortized, but is subject to an impairment review annually and whenever indicators of impairment exist. Goodwill would be impaired if the carrying value of a reporting unit exceeded the fair value of that reporting unit. For the annual impairment review, the company may elect to complete a qualitative assessment to determine if it is more likely than not that the fair value of a reporting unit is less than its carrying value and, if the company determines it is not, then it would not be required to calculate the fair value of the reporting unit. If the company elects to bypass the qualitative assessment or determines that it is more likely than not that the fair value of the reporting unit is less than its carrying value, then the company would calculate the fair value of the reporting unit using the present value of estimated cash flows discounted using a risk-free market rate adjusted for a market participants view of similar companies and perceived risks in the cash flows. If the carrying value of the reporting unit exceeds the fair value of the reporting unit, then the implied fair value of goodwill is determined by subtracting the fair value of all identifiable net assets other than goodwill from the fair value of the reporting unit, with an impairment charge recorded for the excess, if any, of carrying amount of goodwill over the implied fair value.
Intangible Assets Not Subject to Amortization
Indefinite-lived intangible assets, such as acquired IPR&D, are subject to an impairment review annually and whenever indicators of impairment exist. Indefinite-lived intangible assets would be impaired if the carrying amount of the asset exceeded the fair value of the asset.
Other Long-Lived Assets
The company reviews the carrying amounts of long-lived assets, other than goodwill and intangible assets not subject to amortization, for potential impairment when events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In evaluating recoverability, the
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
company groups assets and liabilities at the lowest level such that the identifiable cash flows relating to the company are largely independent of the cash flows of other assets and liabilities. The company then compares the carrying amounts of the assets or asset groups with the related estimated undiscounted future cash flows. In the event impairment exists, an impairment charge is recorded as the amount by which the carrying amount of the asset or asset group exceeds the fair value.
Income Taxes
Income taxes are accounted for under the asset and liability method. Provisions for federal, state and foreign income taxes are calculated on reported pre-tax earnings based on current tax laws. Deferred taxes are provided using enacted tax rates on the future tax consequences of temporary differences, which are the differences between the financial statement carrying amount of assets and liabilities and their respective tax bases and the tax benefits of carryforwards. A valuation allowance is established or maintained when, based on currently available information, it is more likely than not that all or a portion of a deferred tax asset will not be realized.
With respect to uncertain tax positions, the company determines whether the position is more likely than not to be sustained upon examination, based on the technical merits of the position. Any tax position that meets the more likely than not recognition threshold is measured and recognized in the consolidated financial statements at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. The liability relating to uncertain tax positions is classified as current in the consolidated balance sheets to the extent the company anticipates making a payment within one year. Interest and penalties associated with income taxes are classified in the income tax expense line in the consolidated statements of income.
In the companys financial statements for periods prior to July 1, 2015, income tax expense and tax balances were calculated as if the company was a separate taxpayer, although the companys operations were included in tax returns filed by Baxter. After separation on July 1, 2015, income tax expense and income tax balances represent the companys federal, state and foreign income taxes as an independent company.
Prior to the separation, Baxalta maintained an income taxes payable to/from account with Baxter. Baxalta is deemed to have settled current tax balances with the Baxter taxpaying entities in the respective jurisdictions. These settlements were reflected as changes in net parent company investment.
As a standalone entity, the company will file tax returns on its own behalf and its deferred taxes and effective tax rate may not be comparable to those in historical periods.
New Accounting Standards
In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842), which requires lessees to recognize right-of-use assets and lease liabilities on the balance sheet. ASU 2016-02 is to be applied using a modified retrospective approach at the beginning of the earliest comparative period in the financial statements. ASU 2016-02 will be effective for the company beginning on January 1, 2019. Early adoption is permitted. The company is currently evaluating the impact of adopting this standard on its consolidated financial statements.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
In January 2016, the FASB issued ASU No. 2016-01, Financial InstrumentsOverall (Subtopic 825-10)Recognition and Measurement of Financial Assets and Financial Liabilities. ASU 2016-01 requires that equity investments, except those accounted for under the equity method of accounting or those that result in consolidation of the investee, to be measured at fair value, with subsequent changes in fair value recognized in net income. In addition, the ASU requires a qualitative assessment of equity investments without readily determinable fair values when assessing impairment, the evaluation of a valuation allowance on a deferred tax asset related to available-for-sale securities and certain presentation and disclosures for financial instruments. ASU 2016-01 is applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption, which will be January 1, 2018. Early adoption is not permitted. The company is currently evaluating the impact of adopting this standard on its consolidated financial statements.
In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes, which requires that deferred tax assets and liabilities be classified as noncurrent on the balance sheet rather than being separated into current and noncurrent. ASU 2015-17 is effective for fiscal years, and interim periods within those years, beginning after December 31, 2016. Early adoption is permitted, and the company has elected to early adopt on a retroactive basis, which resulted in certain reclassifications to the December 31, 2014 combined balance sheet as further described in Note 14.
In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory, which clarifies that inventory should be measured at the lower of cost or net realizable value. ASU 2015-11 defines net realizable value as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. ASU 2015-11 will be effective for the company beginning on January 1, 2016, and prospective application is required. Early adoption is permitted. The company is currently evaluating the impact of adopting the standard on its consolidated financial statements.
In April 2015, the FASB issued ASU No. 2015-05, IntangiblesGoodwill and OtherInternal-Use Software (Subtopic 350-40): Customers Accounting for Fees Paid in a Cloud Computing Arrangement, which provides guidance to customers about how to account for cloud computing arrangements when such arrangements include software licenses. ASU No. 2015-05 will be effective for the company beginning on January 1, 2016. Early adoption is permitted. The standard may be applied retrospectively or prospectively. The company is currently evaluating the impact of adopting the standard on its consolidated financial statements.
In April 2015, the FASB issued ASU No. 2015-03, InterestImputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs, which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of the debt liability, consistent with debt discounts. ASU No. 2015-03 will be effective for the company beginning on January 1, 2016, and retrospective application is required. Early adoption is permitted, and the company has adopted Accounting Standard Codifications ASC No. 2015-03 effective June 30, 2015. Refer to Note 8 for additional information.
In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), which amends the existing accounting standards for revenue recognition. ASU 2014-09 is based on principles that govern the recognition of revenue at an amount an entity
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
expects to be entitled to when products are transferred to customers. In July 2015, the FASB voted to approve a one-year deferral on the original effective date of January 1, 2017; therefore ASU No. 2014-09 will be effective for the company beginning on January 1, 2018. Early adoption is permitted as of the original effective date. The new revenue standard may be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the date of adoption. The company is currently evaluating the impact of adopting the new revenue standard on its consolidated financial statements.
In April 2014, the FASB issued ASU 2014-08, Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity (ASU 2014-08), which amends the definition of a discontinued operation in ASC 205-20 and provides additional requirements for the entities with its disposal transaction to qualify as a discontinued operation. ASU 2014-08 is effective prospectively for all disposals beginning on or after December 15, 2014 (with early adoption permitted). The company did not early adopt the new guidance and it was effective for the company for periods beginning with its first interim period ending March 31, 2015. ASU 2014-08 did not have a material impact on the consolidated and combined financial statements upon adoption.
NOTE 3 SUPPLEMENTAL FINANCIAL INFORMATION
Net Interest Expense
As described in Note 8, the company issued senior notes with an aggregate principal amount of $5 billion in June 2015. Prior to the issuance of the senior notes, Baxters third-party debt and the related interest expense were not allocated to the company.
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Interest costs |
|
$ |
95 |
|
$ |
|
|
$ |
|
|
Interest costs capitalized |
|
(44 |
) |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Interest expense, net of capitalized interest |
|
51 |
|
|
|
|
|
|||
Interest income |
|
(3 |
) |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Net interest expense |
|
$ |
48 |
|
$ |
|
|
$ |
|
|
Other (Income) Expense, Net
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Net gains related to investments |
|
$ |
(17 |
) |
$ |
(19 |
) |
$ |
(23 |
) |
Change in fair value of contingent payment liabilities |
|
(97 |
) |
124 |
|
18 |
|
|||
Other |
|
12 |
|
(1 |
) |
6 |
|
|||
|
|
|
|
|
|
|
|
|||
Other (income) expense, net |
|
$ |
(102 |
) |
$ |
104 |
|
$ |
1 |
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 3 SUPPLEMENTAL FINANCIAL INFORMATION (Continued)
Prepaid Expenses and Other Current Assets
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
||
Due from Baxter International Inc |
|
$ |
397 |
|
$ |
|
|
Prepaid expenses and other |
|
223 |
|
173 |
|
||
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
$ |
620 |
|
$ |
173 |
|
Accrued Liabilities
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
||
Employee compensation and withholdings |
|
$ |
286 |
|
$ |
210 |
|
Accrued rebates |
|
245 |
|
245 |
|
||
Due to Baxter International Inc |
|
208 |
|
|
|
||
Property, payroll and certain other taxes |
|
97 |
|
78 |
|
||
Income taxes payable |
|
77 |
|
352 |
|
||
Other |
|
289 |
|
271 |
|
||
|
|
|
|
|
|
||
Total accrued liabilities |
|
$ |
1,202 |
|
$ |
1,156 |
|
Other Long-Term Liabilities
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
||
Pension and other employee benefits |
|
$ |
505 |
|
$ |
177 |
|
Contingent payment liabilities |
|
426 |
|
518 |
|
||
Due to Baxter International Inc |
|
64 |
|
|
|
||
Other |
|
53 |
|
154 |
|
||
|
|
|
|
|
|
||
Total other long-term liabilities |
|
$ |
1,048 |
|
$ |
849 |
|
Supplemental Cash Flow Disclosures
Non-cash investing and financing activities
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Accrued capital expenditures |
|
$ |
|
|
$ |
29 |
|
$ |
63 |
|
Assets acquired through capital lease obligations |
|
41 |
|
263 |
|
13 |
|
|||
Interest and taxes paid
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Interest paid, excluding portion capitalized |
|
$ |
39 |
|
$ |
|
|
$ |
|
|
Income taxes paid |
|
119 |
|
|
|
|
|
|||
Prior to the separation, the companys current income tax payables were deemed to be settled with Baxter. Income taxes paid reflect payments in the second half of 2015 following the separation. Interest
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 3 SUPPLEMENTAL FINANCIAL INFORMATION (Continued)
paid in the table primarily reflects payments associated with the companys June 2015 debt issuance as further described in Note 8.
Dividends and Share Repurchase Authorization
On February 23, 2016, Baxaltas Board of Directors declared a quarterly cash dividend of $0.07 per share of common stock. The quarterly dividend is payable on April 1, 2016 to shareholders of record as of the close business on March 10, 2016. On November 17, 2015, Baxaltas Board of Directors declared a quarterly cash dividend of $0.07 per share of common stock. The quarterly dividend was paid on January 4, 2016 to shareholders of record as of the close of business on December 4, 2015. On July 28, 2015, Baxaltas Board of Directors declared a quarterly cash dividend of $0.07 per share of common stock. The quarterly dividend was paid on October 1, 2015, to shareholders of record as of the close of business on September 4, 2015. Pursuant to the merger agreement with Shire, the company is prohibited from declaring a quarterly cash dividend in excess of $0.07 per share.
On July 28, 2015, Baxaltas Board of Directors also approved a share repurchase authorization which allows the company to repurchase up to $1 billion of its common stock. The company did not repurchase any of its common stock during 2015, and pursuant to the merger agreement with Shire, the company may not repurchase or otherwise acquire its own common stock.
NOTE 4 EARNINGS PER SHARE
The denominator for basic earnings per common share (EPS) is the weighted-average number of common shares outstanding during the period. The dilutive effect of outstanding stock options, restricted stock units (RSUs) and performance share units (PSUs) is reflected in the denominator for diluted EPS using the treasury stock method. The numerator for both basic and diluted EPS is net income, net income from continuing operations, or income from discontinued operations, net of tax.
On July 1, 2015, Baxter distributed approximately 544 million shares of Baxalta common stock to its shareholders and retained an additional 132 million shares. The computation of basic EPS for periods prior to the separation was calculated using the shares distributed and retained by Baxter on July 1, 2015 totaling 676 million. The weighted average number of shares outstanding for diluted EPS for periods prior to the separation included 5 million of diluted common share equivalents for stock options, RSUs and PSUs as calculated using the treasury stock method as of July 1, 2015, as these share-based awards were previously issued by Baxter and outstanding at the time of separation and were assumed by Baxalta following the separation.
The following is a reconciliation of basic shares to diluted shares.
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
Basic shares |
|
677 |
|
676 |
|
676 |
|
Effect of dilutive shares |
|
6 |
|
5 |
|
5 |
|
|
|
|
|
|
|
|
|
Diluted shares |
|
683 |
|
681 |
|
681 |
|
The computation of diluted EPS excluded 16 million equity awards for 2015 and 19 million equity awards for each of 2014 and 2013 as their inclusion would have an anti-dilutive effect on diluted EPS.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 5 ACQUISITIONS AND COLLABORATIONS
Acquisitions
The following table summarizes the fair value of consideration transferred and the recognized amounts of the assets acquired and liabilities assumed as of the acquisition date for the companys material acquisitions during 2015, 2014 and 2013.
|
|
|
|
|
|
|
|
|
|
2013 |
|
|||||
|
|
2015 |
|
2014 |
|
Inspiration/
|
|
|||||||||
(in millions) |
|
ONCASPAR |
|
SuppreMol |
|
Chatham |
|
AesRx |
|
OBIZUR |
|
|||||
Consideration transferred |
|
|
|
|
|
|
|
|
|
|
|
|||||
Cash, net of cash acquired |
|
$ |
890 |
|
$ |
228 |
|
$ |
70 |
|
$ |
15 |
|
$ |
51 |
|
Fair value of contingent payments |
|
|
|
|
|
77 |
|
65 |
|
269 |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Fair value of consideration transferred |
|
$ |
890 |
|
$ |
228 |
|
$ |
147 |
|
$ |
80 |
|
$ |
320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Assets acquired and liabilities assumed |
|
|
|
|
|
|
|
|
|
|
|
|||||
Other intangible assets |
|
$ |
794 |
|
$ |
179 |
|
$ |
74 |
|
$ |
78 |
|
$ |
288 |
|
Inventories |
|
22 |
|
|
|
|
|
|
|
|
|
|||||
Other assets |
|
|
|
19 |
|
|
|
|
|
25 |
|
|||||
Accrued liabilities |
|
(1 |
) |
|
|
|
|
|
|
|
|
|||||
Long-term liabilities |
|
(123 |
) |
(53 |
) |
|
|
|
|
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total identifiable net assets |
|
692 |
|
145 |
|
74 |
|
78 |
|
313 |
|
|||||
Goodwill |
|
198 |
|
83 |
|
73 |
|
2 |
|
7 |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total assets acquired and liabilities assumed |
|
$ |
890 |
|
$ |
228 |
|
$ |
147 |
|
$ |
80 |
|
$ |
320 |
|
While the valuation of the assets acquired and liabilities assumed are substantially complete, measurement period adjustments for the acquisitions in 2015 may be recorded in the future as the company finalizes its fair value estimates. Pro forma financial information has not been included because the acquisitions, individually and in the aggregate, would not have had a material impact on the companys consolidated and combined results of operations.
ONCASPAR Business Acquisition
In July 2015, the company acquired the ONCASPAR (pegaspargase) product portfolio from Sigma-Tau Finanziaria S.p.A (Sigma-Tau), a privately held biopharmaceutical company based in Italy, through the acquisition of 100% of the shares of a subsidiary of Sigma-Tau. Through the acquisition, the company gained the marketed biologic treatment ONCASPAR, the investigational biologic calaspargase pegol, and an established oncology infrastructure with clinical and sales resources. ONCASPAR is a first-line biologic used as part of a chemotherapy regimen to treat patients with acute lymphoblastic leukemia. As of the acquisition date, it was marketed in the United States, Germany, Poland and certain other countries, and recently received EU approval. The acquired net assets comprised a business based on the acquired inputs, processes and outputs. As a result, the transaction was accounted for as a business combination.
The company allocated $794 million of the total consideration to developed technology, which reflected rights to the ONCASPAR product portfolio. The developed technology is being amortized on a straight-line basis over an estimated useful life of 16 years. Long-term liabilities acquired consist
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 5 ACQUISITIONS AND COLLABORATIONS (Continued)
primarily of deferred tax liabilities. The goodwill, which is not deductible for tax purposes, includes the value of potential future technologies as well as the overall strategic benefits of the acquisition to the company and its oncology pipeline.
The purchase price allocations described above reflect measurement period adjustments recorded in the fourth quarter of 2015 as the company substantially completed its estimates of the fair value of assets acquired and liabilities assumed. The measurement period adjustments included increases of $13 million, $5 million and $3 million to intangible assets, inventory and long-term liabilities, respectively. The adjustments resulted in a corresponding decrease in goodwill of $15 million. The measurement period adjustments did not have a material impact on the companys results of operations.
Historical annual sales for ONCASPAR were approximately $100 million, and the company has recorded ONCASPAR net sales of $87 million from the acquisition date through December 31, 2015. The company incurred acquisition-related costs of $17 million during 2015, which were primarily recorded in selling, general and administrative expenses.
SuppreMol Acquisition
In March 2015, the company acquired all of the outstanding shares of SuppreMol GmbH (SuppreMol), a privately held biopharmaceutical company based in Germany. Through the acquisition, the company acquired SuppreMols early-stage pipeline of treatment options for autoimmune and allergic diseases, as well as its operations in Munich, Germany. The acquired investigational treatments will complement and build upon the companys immunology portfolio and offer an opportunity to expand into new areas with significant market potential and unmet medical needs in autoimmune diseases. The acquired net assets comprised a business based on the acquired inputs, processes and outputs. As a result, the transaction has been accounted for as a business combination.
The company allocated $179 million of the total consideration to IPR&D, which is being accounted for as an indefinite-lived intangible asset. The acquired IPR&D primarily relates to SuppreMols lead candidate SM-101, an investigational immunoregulatory treatment, which had completed Phase IIa studies at the time of the acquisition. This project was expected to be completed in approximately 5 years as of the acquisition date. The value of the IPR&D was calculated using cash flow projections adjusted for the inherent technical, regulatory, commercial and obsolescence risks in such activities, discounted at a rate of 20%. Additional R&D will be required prior to regulatory approval, and as of the acquisition date, incremental R&D costs were projected to be in excess of $400 million. Other assets acquired included deferred tax assets of $17 million and long-term liabilities acquired included $52 million of deferred tax liabilities. The goodwill, which is not deductible for tax purposes, includes the value of potential future technologies as well as the overall strategic benefits of the acquisition to the company.
AesRx, LLC Acquisition
In June 2014, the company acquired all of the outstanding membership interests in AesRx, LLC (AesRx), obtaining AesRxs program related to the development and commercialization of treatments for sickle cell disease.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 5 ACQUISITIONS AND COLLABORATIONS (Continued)
The company made an initial payment of $15 million, and as of the acquisition date may make additional payments of up to $278 million related to the achievement of development and regulatory milestones, in addition to sales milestones of up to $550 million. The estimated fair value of the contingent payment liabilities at the acquisition date was $65 million, which was recorded in long-term liabilities, and was calculated based on the probability of achieving the specified milestones and the discounting of expected future cash flows.
The company allocated $78 million of the total consideration to acquired IPR&D, which was accounted for as an indefinite-lived intangible asset, with the residual consideration of $2 million recorded as goodwill. The acquired IPR&D related to AesRxs sickle cell disease program, which was in Phase II clinical trials at the time of the acquisition, and was expected to be completed in approximately five years. The value of IPR&D was calculated using cash flow projections adjusted for the inherent technical, regulatory, commercial and obsolescence risks in such activities, discounted at a rate of 15.5%. Additional R&D was required prior to obtaining regulatory approval and, as of the acquisition date, incremental R&D costs were projected to be in excess of $40 million.
During 2015, the company decided not to pursue further development activities related to the acquired project. The company recorded a charge of $81 million in R&D expenses to fully impair the acquired IPR&D and a gain of $66 million resulting primarily from the reduction of the fair value of contingent payment liabilities to zero as of December 31, 2015.
Chatham Therapeutics, LLC Acquisition
In April 2014, the company acquired all of the outstanding membership interests in Chatham Therapeutics, LLC (Chatham), obtaining potential treatments for hemophilia B utilizing Chathams gene therapy technology.
The company made an initial payment of $70 million, and as of the acquisition date may make additional payments of up to $560 million related to the achievement of development, regulatory and first commercial sale milestones, in addition to other sales milestones of up to $780 million. The estimated fair value of the contingent payment liabilities at the acquisition date was $77 million, which was recorded in long-term liabilities, and was calculated based on the probability of achieving the specified milestones and the discounting of expected future cash flows. As of December 31, 2015, the estimated fair value of the contingent payments was $74 million, with changes in the estimated fair value recognized in other (income) expense, net within the consolidated and combined statements of income. Refer to Note 10 for additional information regarding the contingent payment liability.
The company allocated $74 million of the total consideration to acquired IPR&D, which is being accounted for as an indefinite-lived intangible asset, with the residual consideration of $73 million recorded as goodwill. The acquired IPR&D primarily relates to Chathams hemophilia A (factor VIII) program, which was in preclinical stage at the time of the acquisition and was expected to be completed in approximately 10 years as of the acquisition date. The value of the IPR&D was calculated using cash flow projections adjusted for the inherent technical, regulatory, commercial and obsolescence risks in such activities, discounted at a rate of 12%. Additional R&D will be required prior to obtaining regulatory approval and, as of the acquisition date, incremental R&D costs were projected to be in excess of $130 million. The goodwill, which may be deductible for tax purposes depending on the ultimate resolution of the contingent payment liabilities, includes the value of potential future
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 5 ACQUISITIONS AND COLLABORATIONS (Continued)
technologies as well as the overall strategic benefits of the acquisition to the company in the hemophilia market.
Inspiration / Ipsen Acquisition
In March 2013, the investigational hemophilia compound OBIZUR and related assets were acquired from Inspiration BioPharmaceuticals, Inc. (Inspiration), and certain other OBIZUR related assets, including manufacturing operations, were acquired from Ipsen Pharma S.A.S. (Ipsen) in conjunction with Inspirations bankruptcy proceedings. Ipsen was Inspirations senior secured creditor and had been providing Inspiration with debtor-in-possession financing to fund Inspirations operations and the sales process. Additionally, Ipsen was the owner of certain assets acquired in the transaction.
OBIZUR is a recombinant porcine factor VIII that was approved in the United States in 2014 and in Canada and Europe in 2015 for the treatment of patients with acquired hemophilia A, and is being investigated for the treatment of congenital hemophilia A patients with inhibitors.
The estimated fair value of contingent payment liabilities at the acquisition date was $269 million, based on the probability of achieving the specified milestones, of up to $135 million, and sales-based payments, and the discounting of expected future cash flows. The estimated fair value of contingent payment liabilities was recorded in other long-term liabilities as part of the consideration transferred. As of December 31, 2015, the estimated fair value of the contingent payments was $360 million, with changes in the estimated fair value recognized in other (income) expense, net within the consolidated and combined statements of income. Refer to Note 10 for additional information regarding the contingent payment liability.
Goodwill of $7 million principally included the value associated with the assembled workforce at the acquired manufacturing facility. The goodwill is deductible for tax purposes. Other intangible assets of $288 million related to acquired IPR&D activities, and the total was accounted for as an indefinite-lived intangible asset at the acquisition date. The value of the IPR&D was calculated using cash flow projections adjusted for the inherent technical, regulatory, commercial and obsolescence risk associated with such activities, discounted at a rate of 13%. In 2014, the acquired IPR&D was reclassified as a definite-lived intangible asset following regulatory approval. It is being amortized on a straight-line basis over an estimated useful life of 15 years.
Collaborations
Precision BioSciences
In February 2016, Baxalta entered into a strategic immuno-oncology collaboration with Precision BioSciences (Precision), a private biopharmaceutical company based in the United States, specializing in genome editing technology. Together, Baxalta and Precision will develop chimeric antigen receptor (CAR) T cell therapies for up to six unique targets, with the first program expected to enter clinical studies in late 2017. On a product-by-product basis, following successful completion of early-stage research activities up to Phase 2, Baxalta will have exclusive option rights to complete late-stage development and worldwide commercialization. Precision is responsible for development costs for each target prior to option exercise. The company will make an upfront payment of $105 million to Precision, which will be recorded as R&D expense in the first quarter of 2016. The company may make additional payments related to option fees and development, regulatory, and commercial milestones totaling up to $1.6 billion, in addition to future royalty payments on worldwide sales. Precision also has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 5 ACQUISITIONS AND COLLABORATIONS (Continued)
Symphogen
In December 2015, the company entered into a research, option and commercial agreement with Symphogen, a private biopharmaceutical company headquartered in Denmark that is developing recombinant antibodies and antibody mixtures. Under the terms of the agreement, the company has options to obtain exclusive licensing rights for three specified proteins in development for the treatment of immune-oncology diseases as well as three additional proteins that may be selected at a later date. Each option is exercisable for a period of 90 days when each protein is ready for Phase II clinical trials. Symphogen is responsible for development costs for each protein until option exercise, at which point Baxalta would be responsible for development costs.
The company made an upfront payment of $175 million in January 2016, which was recognized as R&D expense in 2015 upon entering into the agreement. Each option exercise fee is variable depending on when it is exercised, with a maximum exercise price of up to 20 million for each protein. The company may make additional payments of up to approximately 1.2 billion related to development, regulatory and commercial milestones achieved after option exercise for all six proteins, in addition to future royalty payments.
SFJ Pharmaceuticals Group
In June 2015, the company entered into an agreement with SFJ Pharmaceuticals Group (SFJ) relating to adalimumab (BAX 923), whereby SFJ will fund up to $200 million of specified development costs related to the companys BAX 923 program, in exchange for payments in the event the product obtains regulatory approval in the United States or Europe. The terms of the agreement include funding limitations of up to $50 million for incurred costs through Phase I development and cumulative spending caps in six month intervals through December 31, 2017. The contingent success payments total approximately 5.5 times the incurred development costs and are payable in annual installments over an approximate eight-year period following the dates of regulatory approval. The development funding from SFJ is being recognized as an offset to R&D expenses as incurred because there is substantive and genuine transfer of risk to SFJ. The R&D expense offset for 2015 totaled $58 million. BAX923 is one of the biosimilars in which the company is collaborating with Momenta Pharmaceuticals, Inc. as further described below.
Merrimack Pharmaceuticals, Inc.
In September 2014, the company entered into an exclusive license agreement with Merrimack Pharmaceuticals, Inc. (Merrimack) relating to the development and commercialization of MM-398 (nanoliposomal irinotecan injection), also known as nal-IRI. The arrangement includes all potential indications for MM-398 across all markets with the exception of the United States and Taiwan. The first indication being pursued is for the treatment of patients with metastatic pancreatic cancer who were previously treated with gemcitabine-based therapy. In 2014, the company recognized an R&D charge of $100 million related to the upfront payment. Upon entering into the agreement, the company had the potential to make future payments of up to $870 million related to the achievement of development, regulatory, and commercial milestones, in addition to royalty payments.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 5 ACQUISITIONS AND COLLABORATIONS (Continued)
CTI BioPharma Corp.
In November 2013, the company acquired approximately 16 million shares of CTI BioPharma Corp. (CTI BioPharma), which was formerly named Cell Therapeutics, Inc., common stock for $27 million. The company also entered into an exclusive worldwide licensing agreement with CTI BioPharma to develop and commercialize pacritinib, a novel investigational JAK2/FLT3 inhibitor with activity against genetic mutations linked to myelofibrosis, leukemia and certain solid tumors. At the time the company entered into the agreement, pacritinib was in Phase III development for patients with myelofibrosis, a chronic malignant bone marrow disorder. Under the terms of the agreement, the company gained commercialization rights for all indications of pacritinib outside the United States, while the company and CTI BioPharma will jointly commercialize pacritinib in the United States. Under the terms of the initial agreement, CTI BioPharma is responsible for the funding of the majority of development activities as well as the manufacture of the product. In 2013, the company recognized an R&D charge of $33 million related to an upfront payment. Upon entering into the agreement, the company had the potential to make future payments of up to $302 million related to the achievement of development, regulatory and commercial milestones, in addition to future royalty payments.
In June 2015, the company entered into an amendment with CTI BioPharma Corp (CTI BioPharma). Pursuant to the amendment, the company paid $32 million to CTI BioPharma relating to two contingent milestone payments included in the original agreement. The company obtained certain additional rights relating to manufacturing and supply, and CTI BioPharma committed to spend a specified amount on the development of pacritinib through February 2016, with failure to do so resulting in payments to the company equal to the deficiency.
Coherus Biosciences, Inc.
In August 2013, the company entered into an exclusive license agreement with Coherus Biosciences, Inc. (Coherus) to develop and commercialize a biosimilar to ENBREL® (etanercept) for Europe, Canada, Brazil and certain other markets. The company also has the right of first refusal to certain other biosimilars in the collaboration. Under the terms of the agreement, Coherus is responsible for the development plan, preparation of regulatory filings, and manufacture of the product, subject to certain cost reimbursement by the company. The company can terminate the agreement if certain costs exceed a specific cap. In 2013, the company recognized an R&D charge of $30 million related to its decision to pursue the development of etanercept. Upon entering into the agreement, the company had the potential to make future payments of up to $169 million relating to the achievement of development and regulatory milestones, in addition to future royalty payments.
Momenta Pharmaceuticals, Inc.
In February 2012, the company entered into an exclusive license agreement with Momenta to develop and commercialize biosimilars. The arrangement includes specified funding by the company, as well as other responsibilities, relating to development and commercialization activities. In 2012, the company recognized an R&D charge of $33 million related to an upfront payment. Upon entering into the agreement, the company had the potential to make future payments of up to approximately $202 million related to the exercise of options to develop additional products and the achievement of technical, development and regulatory milestones for these products, in addition to future royalty payments and potential profit-sharing payments.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 5 ACQUISITIONS AND COLLABORATIONS (Continued)
Payments to Collaboration Partners
R&D expenses related to payments to collaboration partners were $430 million, $242 million and $80 million during 2015, 2014, and 2013, respectively. Expenses related to upfront payments were $175 million, $100 million and $63 million during 2015, 2014 and 2013, respectively; and expenses related to milestone payments were $215 million, $117 million and $15 million during 2015, 2014 and 2013, respectively. The remainder primarily related to R&D cost reimbursements. Payments to collaboration partners classified in cost of sales were not significant in 2015, 2014 and 2013.
Unfunded Contingent Payments
At December 31, 2015, the companys unfunded contingent milestone payments associated with all of its collaborative arrangements totaled $2.1 billion. This total includes contingent payments associated with the SFJ agreement related to development costs funded through December 31, 2015. This total excludes contingent royalty and profit-sharing payments, contingent payment liabilities arising from business combinations, which are further discussed in Note 11, and potential milestone payments and option exercise fees associated with the Symphogen arrangement because they would be payable only if the company chooses to exercise one or more of its options. Based on the companys projections, any contingent payments made in the future will be more than offset by the estimated net future cash flows relating to the rights acquired for those payments.
NOTE 6 GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill
The following is a summary of the activity in goodwill:
(in millions) |
|
|
|
|
December 31, 2013 |
|
$ |
524 |
|
Additions |
|
75 |
|
|
Currency translation and other adjustments |
|
(34 |
) |
|
December 31, 2014 |
|
$ |
565 |
|
Additions |
|
281 |
|
|
Currency translation and other adjustments |
|
(17 |
) |
|
December 31, 2015 |
|
$ |
829 |
|
The additions during 2015 related to the acquisition of the ONCASPAR business and SuppreMol. The additions during 2014 primarily related to the acquisition Chatham. These acquisitions are further discussed in Note 5.
As of December 31, 2015, there were no accumulated goodwill impairment losses.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 6 GOODWILL AND OTHER INTANGIBLE ASSETS (Continued)
Other intangible assets, net
The following is a summary of the companys other intangible assets:
(in millions) |
|
Developed
|
|
Other
|
|
Indefinite-
|
|
Total |
|
||||
December 31, 2015 |
|
|
|
|
|
|
|
|
|
||||
Gross other intangible assets |
|
$ |
1,247 |
|
$ |
29 |
|
$ |
238 |
|
$ |
1,514 |
|
Accumulated amortization |
|
(190 |
) |
(29 |
) |
|
|
(219 |
) |
||||
Other intangible assets, net |
|
$ |
1,057 |
|
$ |
|
|
$ |
238 |
|
$ |
1,295 |
|
December 31, 2014 |
|
|
|
|
|
|
|
|
|
||||
Gross other intangible assets |
|
$ |
440 |
|
$ |
29 |
|
$ |
149 |
|
$ |
618 |
|
Accumulated amortization |
|
(133 |
) |
(26 |
) |
|
|
(159 |
) |
||||
Other intangible assets, net |
|
$ |
307 |
|
$ |
3 |
|
$ |
149 |
|
$ |
459 |
|
The increase in other intangible assets, net during the year ended December 31, 2015 was primarily due to IPR&D acquired in the acquisition of SuppreMol and developed technology acquired in the acquisition of the ONCASPAR business, partially offset by an impairment charge on IPR&D from the AesRx acquisition, as further described in Note 5, amortization expense and CTA.
Intangible asset amortization expense was $53 million and $16 million in the years ended December 31, 2015 and 2014, respectively. The following table presents anticipated annual amortization expense for 2016 through 2020 for definite-lived intangible assets recorded as of December 31, 2015:
(in millions) |
|
2016 |
|
2017 |
|
2018 |
|
2019 |
|
2020 |
|
|||||
Anticipated annual intangible asset amortization expense |
|
$ |
77 |
|
$ |
74 |
|
$ |
73 |
|
$ |
69 |
|
$ |
69 |
|
NOTE 7 BUSINESS OPTIMIZATION ITEMS
Prior to the separation, the company participated in business optimization plans initiated by Baxter. The companys total charges (benefits) related to business optimization plans are presented below:
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Charges |
|
$ |
5 |
|
$ |
43 |
|
$ |
133 |
|
Reserve adjustments |
|
(17 |
) |
(10 |
) |
|
|
|||
Total business optimization (benefits) expenses |
|
(12 |
) |
33 |
|
133 |
|
|||
Discontinued operations |
|
|
|
(8 |
) |
(101 |
) |
|||
Business optimization (benefits) expenses in continuing operations |
|
$ |
(12 |
) |
$ |
25 |
|
$ |
32 |
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 7 BUSINESS OPTIMIZATION ITEMS (Continued)
During 2015, the company adjusted certain previously estimated business optimization charges resulting in a $17 million benefit. The adjustments were primarily due to lower severance payments than previously estimated from business optimization programs in prior years. The 2015 period also included charges of $5 million in selling, general and administrative expenses primarily relating to re-alignment of certain functions. During 2014, the company recorded charges of $2 million in cost of sales, $1 million in selling, general and administrative expenses and $22 million in R&D expenses (with an additional $8 million recorded in discontinued operations). The charges during 2014 primarily related to re-alignment of certain R&D activities and rationalization of manufacturing facilities. During 2013, the company recorded charges of $5 million in cost of sales, $3 million in selling, general and administrative expenses and $24 million in R&D expenses (with an additional $101 million recorded in discontinued operations). The charges during 2013 included severance and other non-cash impairment losses associated with the discontinuation of certain R&D programs associated with the vaccines business.
The following table summarizes activity in the reserves related to business optimization initiatives:
(in millions) |
|
|
|
|
Reserves as of December 31, 2014 |
|
$ |
60 |
|
Charges |
|
5 |
|
|
Reserve adjustments |
|
(17 |
) |
|
Separation-related adjustments and other |
|
(17 |
) |
|
Utilization |
|
(19 |
) |
|
Reserves as of December 31, 2015 |
|
$ |
12 |
|
Separation-related adjustments and other included a reduction in the companys business optimization reserves related to certain liabilities that were not transferred to Baxalta as part of the separation and the impact of CTA.
The reserves are expected to be substantially utilized by the end of 2016. Management believes that these reserves are adequate. However, adjustments may be recorded in the future as the programs are completed.
NOTE 8 DEBT, CAPITAL LEASE OBLIGATIONS AND OTHER FINANCING ARRANGEMENTS
As of December 31, 2014 and through the date of the senior notes issuance described below, Baxters third-party debt and the related interest expense were not allocated to the company as the company was not the legal obligor of the debt and Baxter borrowings were not directly attributable to the companys business.
Significant Debt Issuances
On June 23, 2015, the company issued senior notes with a total aggregate principal amount of $5 billion. The company used the net proceeds to make a cash distribution of $4 billion to Baxter as partial consideration for the contribution of net assets to the company in connection with the separation, and the remainder was or is intended to be used for general corporate purposes, including to fund acquisitions. The $4 billion cash distribution to Baxter was made on June 23, 2015.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 8 DEBT, CAPITAL LEASE OBLIGATIONS AND OTHER FINANCING ARRANGEMENTS (Continued)
Below is a summary of the companys debt and capital lease obligations outstanding as of December 31, 2015.
(in millions, except for percentage information) |
|
Aggregate
|
|
Coupon
|
|
Effective
|
|
Carrying
|
|
||
Variable-rate notes due 2018 |
|
$ |
375 |
|
LIBOR plus 0.78 |
% |
1.3 |
% |
$ |
373 |
|
Fixed-rate notes due 2018 |
|
375 |
|
2.000 |
% |
2.2 |
% |
373 |
|
||
Fixed-rate notes due 2020 |
|
1,000 |
|
2.875 |
% |
2.9 |
% |
994 |
|
||
Fixed-rate notes due 2022 |
|
500 |
|
3.600 |
% |
3.6 |
% |
496 |
|
||
Fixed-rate notes due 2025 |
|
1,750 |
|
4.000 |
% |
4.0 |
% |
1,730 |
|
||
Fixed-rate notes due 2045 |
|
1,000 |
|
5.250 |
% |
5.1 |
% |
983 |
|
||
Other (including capital lease obligations) |
|
N/A |
|
N/A |
|
N/A |
|
319 |
|
||
Total debt and capital lease obligations |
|
|
|
|
|
|
|
5,268 |
|
||
Current portion |
|
|
|
|
|
|
|
(3 |
) |
||
Long-term portion |
|
|
|
|
|
|
|
$ |
5,265 |
|
|
(1) Excludes the effect of any related interest rate swaps.
(2) Book values include any discounts, premiums and adjustments related to hedging instruments.
In connection with this issuance, the company recognized a debt discount of $51 million and deferred issuance costs totaling $8 million, which were recorded as a direct deduction from the carrying amount of the debt. Refer to Note 9 for information regarding interest rate derivative contracts the company has entered into related to the senior notes.
Credit Facilities
In July 2015, the company entered into a credit agreement providing for a senior revolving credit facility that provides the company with access to an aggregate principal amount of up to $1.2 billion maturing in 2020, of which no amounts are currently outstanding. Effective November 12, the company entered into Amendment No. 1 to the credit agreement. The amendment narrows the definition of Change of Control. The other material terms of the credit agreement, including covenants, remain unchanged. The facility enables the company to borrow funds on an unsecured basis at variable interest rates, and contains various financial and other covenants, including a net leverage ratio covenant and an interest coverage ratio covenant, as well as events of default with respect to the company. The credit facility also provides for the issuance of letters of credit, which reduces the maximum capacity of this facility. At December 31, 2015, the amount of letters of credit issued was insignificant.
The company also entered into a Euro-denominated senior revolving credit facility in an aggregate principal amount of up to 200 million maturing in 2020, with similar terms as the above credit facility, of which no amounts are currently outstanding. Effective November 12, 2015, the company entered into an amendment to this credit facility. Similar to the amendment discussed above, this amendment narrows the definition of Change of Control. The non-performance of any financial institution
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 8 DEBT, CAPITAL LEASE OBLIGATIONS AND OTHER FINANCING ARRANGEMENTS (Continued)
supporting either of the credit facilities would reduce the maximum capacity of these facilities by each institutions respective commitment.
The company also maintains other credit arrangements, which totaled $80 million at December 31, 2015. There were no borrowings outstanding under these arrangements at December 31, 2015.
Capital Lease Obligations
The company leases certain facilities under capital leases. During 2014, the company entered into a leasing arrangement for a new global innovation center in Cambridge, Massachusetts and recorded a capital lease obligation of $263 million. During 2015, the company entered into a leasing arrangement for its corporate headquarters in Bannockburn, Illinois and recorded a capital lease obligation of $41 million. As of December 31, 2015 and 2014, the companys total capital lease obligations, including current maturities, were $319 million and $275 million, respectively.
Future Payments on Capital Lease Obligations and Debt Maturities
(in millions) |
|
December 31,
|
|
|
2016 |
|
$ |
3 |
|
2017 |
|
31 |
|
|
2018 |
|
768 |
|
|
2019 |
|
18 |
|
|
2020 |
|
1,018 |
|
|
Thereafter |
|
3,612 |
|
|
Total obligations |
|
5,450 |
|
|
Fair value hedges and unamortized bond discounts |
|
(182 |
) |
|
Total debt and capital lease obligations |
|
$ |
5,268 |
|
NOTE 9 DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITY
The company does not hold any instruments for trading purposes and none of the companys outstanding derivative instruments contain credit-risk-related contingent features.
Interest Rate Risk Management
The company is exposed to the risk that its earnings and cash flows could be adversely impacted by fluctuations in benchmark interest rates relating to its existing debt obligations or anticipated issuances of debt. The companys policy is to manage this risk to an acceptable level.
Foreign Currency Risk Management
The company is primarily exposed to foreign exchange risk with respect to recognized assets and liabilities, forecasted transactions and net assets denominated in the Euro, Japanese Yen, British Pound, Swiss Franc, Australian Dollar, Turkish Lira, Russian Ruble, Chinese Renminbi, Colombian Peso and Argentine Peso.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 9 DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITY (Continued)
In periods prior to the separation, the company participated in Baxters foreign currency risk management program through a central shared entity, which entered into derivative contracts to hedge foreign currency risk associated with forecasted transactions for the entire company, including for Baxaltas operations. Gains and losses on derivative contracts entered into by Baxter were allocated to Baxalta and partially offset gains and losses on underlying foreign currency exposures. The fair value of outstanding derivative instruments were not allocated to Baxaltas combined balance sheets. In connection with the separation, the company began entering into foreign currency derivative contracts on its own behalf and has recorded the related fair value on its consolidated and combined balance sheet as of December 31, 2015. The contracts are classified as either short-term or long-term based on the scheduled maturity of the instrument.
Cash Flow Hedges
The company may use options, including collars and purchased options, and forwards to hedge the foreign exchange risk to earnings relating to forecasted transactions and recognized assets and liabilities. In December 2014 and during the three months ended March 31, 2015, the company entered into $1.8 billion of forward-starting interest rate swaps to hedge the risk to earnings associated with movements in benchmark interest rates relating to an anticipated issuance of debt. The total notional amount of the forward-starting interest rate swaps was $550 million as of December 31, 2014. During 2015, in conjunction with the debt issuance described in Note 8, the company terminated the swaps, which resulted in a $37 million net gain that was deferred in AOCI and is being amortized as a decrease to net interest expense over the terms of the underlying debt.
For each derivative instrument that is designated and effective as a cash flow hedge, the gain or loss on the derivative is recorded in AOCI and then recognized in earnings consistent with the underlying hedged item. Option premiums or net premiums paid are initially recorded as assets and reclassified to other comprehensive income (OCI) over the life of the option, and then recognized in earnings consistent with the underlying hedged item. Cash flow hedges are classified in net sales, cost of sales, and net interest expense, and primarily relate to forecasted third-party sales denominated in foreign currencies, forecasted intercompany sales denominated in foreign currencies, and anticipated issuances of debt, respectively. The maximum term over which the company has cash flow hedge contracts in place related to forecasted transactions as of December 31, 2015 was 12 months. The notional amount of foreign exchange contracts were $1.2 billion as of December 31, 2015.
In certain instances, the company may discontinue cash flow hedge accounting because the forecasted transactions are no longer probable of occurring. As of December 31, 2015, all forecasted transactions were probable of occurring and no gains or losses were reclassified into earnings.
Fair Value Hedges
The company uses interest rate swaps to convert a portion of its fixed-rate debt into variable-rate debt. These instruments hedge the companys earnings from changes in the fair value of debt due to fluctuations in the designated benchmark interest rate. For each derivative instrument that is designated and effective as a fair value hedge, the gain or loss on the derivative is recognized immediately to earnings, and offsets the loss or gain on the underlying hedged item. Fair value hedges are classified in net interest expense, as they hedge the interest rate risk associated with certain of the companys fixed-rate debt.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 9 DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITY (Continued)
The total notional amount of interest rate swaps was $1.0 billion as of December 31, 2015. There were no interest rate swaps designated as fair value hedges as of December 31, 2014.
Undesignated Derivative Instruments
The company uses forward contracts to hedge earnings from the effects of foreign exchange relating to certain of the companys intercompany and third-party receivables and payables denominated in a foreign currency. These derivative instruments generally are not formally designated as hedges, the terms of these instruments generally do not exceed one month, and the change in fair value of these derivatives are reported in earnings.
The total notional amount of undesignated derivative instruments was $209 million as of December 31, 2015.
Gains and Losses on Derivative Instruments
The following tables summarize the income statement locations and gains and losses on the companys derivative instruments for the years ended December 31, 2015 and 2014.
|
|
Gain (loss)
|
|
Location of gain (loss) |
|
Gain (loss)
|
|
||||||||
(in millions) |
|
2015 |
|
2014 |
|
in income statement |
|
2015 |
|
2014 |
|
||||
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
||||
Interest rate contracts |
|
$ |
38 |
|
$ |
|
|
Net interest expense |
|
$ |
1 |
|
$ |
|
|
Foreign exchange contracts |
|
|
|
|
|
Net sales |
|
|
|
|
|
||||
Foreign exchange contracts |
|
19 |
|
|
|
Cost of sales |
|
46 |
|
|
|
||||
Total |
|
$ |
57 |
|
$ |
|
|
|
|
$ |
47 |
|
$ |
|
|
|
|
Location of gain (loss) |
|
Gain (loss)
|
|
||||
(in millions) |
|
in income statement |
|
2015 |
|
2014 |
|
||
Fair value hedges |
|
|
|
|
|
|
|
||
Interest rate contracts |
|
Net interest expense |
|
$ |
4 |
|
$ |
|
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
Other income, net |
|
$ |
(4 |
) |
$ |
|
|
During 2015, the company assumed pre-tax deferred gains of $43 million related to certain foreign exchange contracts from Baxter, which were recorded in AOCI.
For the companys fair value hedges, a loss of $4 million was recognized in net interest expense during 2015, as adjustments to the underlying hedged item, fixed-rate debt. Ineffectiveness related to the companys cash flow and fair value hedges for 2015 was not material.
As of December 31, 2015, $11 million of deferred, net after-tax gains on derivative instruments included in AOCI are expected to be recognized in earnings during the next 12 months, coinciding with
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 9 DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITY (Continued)
when the hedged items are expected to impact earnings. Refer to Note 13 for the balance in AOCI associated with cash flow hedges.
Fair Values of Derivative Instruments
The following table presents the classification and estimated fair value of the companys derivative instruments as of December 31, 2015:
|
|
Derivatives in asset positions |
|
Derivatives in liability positions |
|
||||||
(in millions) |
|
Balance sheet location |
|
Fair value |
|
Balance sheet location |
|
Fair value |
|
||
Derivative instruments designated as hedges |
|
|
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
Other current assets |
|
$ |
23 |
|
Accrued liabilities |
|
$ |
2 |
|
Foreign exchange contracts |
|
Other long-term assets |
|
|
|
Other long-term liabilities |
|
|
|
||
Interest rate contracts |
|
Other long-term assets |
|
4 |
|
|
|
|
|
||
Total derivative instruments designated as hedges |
|
|
|
$ |
27 |
|
|
|
$ |
2 |
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
Other current assets |
|
$ |
1 |
|
Accrued liabilities |
|
$ |
1 |
|
Total derivative instruments |
|
|
|
$ |
28 |
|
|
|
$ |
3 |
|
The following table presents the classification and estimated fair value of the companys derivative instruments as of December 31, 2014:
|
|
Derivatives in asset positions |
|
Derivatives in liability positions |
|
||||||
(in millions) |
|
Balance sheet
|
|
Fair value |
|
Balance sheet
|
|
Fair value |
|
||
Derivative instruments designated as hedges |
|
|
|
|
|
|
|
|
|
||
Interest rate contracts |
|
Other current assets |
|
$ |
1 |
|
Accrued liabilities |
|
$ |
2 |
|
While the companys derivatives are all subject to master netting arrangements, the company presents its assets and liabilities related to derivative instruments on a gross basis within the consolidated and combined balance sheets. Additionally, the company is not required to post collateral for any of its outstanding derivatives. If the companys derivatives were presented on a net basis, an asset of $25 million and liability of $1 million would be reported at December 31, 2015 and 2014, respectively.
NOTE 10 FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Securitization arrangement
In April 2015, the company entered into agreements related to its trade receivables originating in Japan with a financial institution in which the entire interest in and ownership of the receivables are sold. While the company services the receivables in its Japanese securitization arrangement, no servicing asset or liability is recognized because the company receives adequate compensation to service the sold receivables.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 10 FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS (Continued)
During 2015, sold receivables were $165 million and cash collections remitted to the owners of the receivables were $98 million. The effect of currency exchange rate changes and net losses relating to the sales of receivables were immaterial.
Fair Value Measurements
The fair value hierarchy under the accounting standard for fair value measurements consists of the following three levels:
· Level 1Quoted prices in active markets that the company has the ability to access for identical assets or liabilities;
· Level 2Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-based valuations in which all significant inputs are observable in the market; and
· Level 3Valuations using significant inputs that are unobservable in the market and include the use of judgment by the companys management about the assumptions market participants would use in pricing the asset or liability.
The following tables summarize the bases used to measure financial assets and liabilities that are carried at fair value on a recurring basis in the consolidated and combined balance sheets:
|
|
|
|
Basis of fair value measurement |
|
||||||||
(in millions) |
|
Balance as of
|
|
Quoted prices
|
|
Significant
|
|
Significant
|
|
||||
Assets |
|
|
|
|
|
|
|
|
|
||||
Foreign currency derivative contracts |
|
$ |
24 |
|
$ |
|
|
$ |
24 |
|
$ |
|
|
Interest rate contracts |
|
4 |
|
|
|
4 |
|
|
|
||||
Available-for-sale securities |
|
|
|
|
|
|
|
|
|
||||
Equity securities |
|
78 |
|
78 |
|
|
|
|
|
||||
Foreign government debt securities |
|
16 |
|
3 |
|
13 |
|
|
|
||||
Total assets |
|
$ |
122 |
|
$ |
81 |
|
$ |
41 |
|
$ |
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
||||
Contingent payments related to acquisitions |
|
$ |
433 |
|
$ |
|
|
$ |
|
|
$ |
433 |
|
Foreign currency derivative contracts |
|
3 |
|
|
|
3 |
|
|
|
||||
Total liabilities |
|
$ |
436 |
|
$ |
|
|
$ |
3 |
|
$ |
433 |
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 10 FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS (Continued)
|
|
|
|
Basis of fair value measurement |
|
||||||||
(in millions) |
|
Balance as of
|
|
Quoted prices
|
|
Significant
|
|
Significant
|
|
||||
Assets |
|
|
|
|
|
|
|
|
|
||||
Available-for-sale securities |
|
|
|
|
|
|
|
|
|
||||
Equity securities |
|
$ |
71 |
|
$ |
71 |
|
$ |
|
|
$ |
|
|
Foreign government debt securities |
|
18 |
|
3 |
|
15 |
|
|
|
||||
Interest rate contracts |
|
1 |
|
|
|
1 |
|
|
|
||||
Total assets |
|
$ |
90 |
|
$ |
74 |
|
$ |
16 |
|
$ |
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
||||
Contingent payments related to acquisitions |
|
$ |
518 |
|
$ |
|
|
$ |
|
|
$ |
518 |
|
Interest rate contracts |
|
2 |
|
|
|
2 |
|
|
|
||||
Total liabilities |
|
$ |
520 |
|
$ |
|
|
$ |
2 |
|
$ |
518 |
|
As of December 31, 2015, cash and equivalents of $1.0 billion included money market funds of approximately $100 million. Money market funds would be considered Level 2 in the fair value hierarchy.
For assets that are measured using quoted prices in active markets, the fair value is the published market price per unit multiplied by the number of units held, without consideration of transaction costs. The fair values of foreign government debt securities are obtained from pricing services or broker/dealers who either use quoted prices in an active market or proprietary pricing applications, which include observable market information for like or same securities.
Contingent payments related to acquisitions consist of development, regulatory and commercial milestone payments, in addition to sales-based payments, and are valued using discounted cash flow techniques. The fair value of development, regulatory and commercial milestone payments reflects managements expectations of probability of payment, and increases or decreases as the probability of payment or expectation of timing of payments changes. As of December 31, 2015, managements expected weighted-average probability of payment for development, regulatory and commercial milestone payments was approximately 21%, with individual probabilities ranging from 10%-80%. As of December 31, 2015 the weighted average discount rate used in the fair value estimates was 8.1%.
The fair value of sales-based payments is based upon probability-weighted future revenue estimates, and increases or decreases as revenue estimates or expectations of timing of payments change.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 10 FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS (Continued)
The following table provides information relating to the companys investments in available-for-sale equity securities:
(in millions) |
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair value |
|
||||
December 31, 2015 |
|
|
|
|
|
|
|
|
|
||||
Available-for-sale equity securities |
|
$ |
55 |
|
$ |
28 |
|
$ |
(5 |
) |
$ |
78 |
|
December 31, 2014 |
|
|
|
|
|
|
|
|
|
||||
Available-for-sale equity securities |
|
$ |
59 |
|
$ |
21 |
|
$ |
(9 |
) |
$ |
71 |
|
During 2015, the company recorded $14 million in other-than-temporary impairment charges based on the duration of losses related to three of the companys investments. During 2014, the company recorded a $45 million other-than-temporary impairment charge to write-down the investment in Onconova common stock to its fair value based on the duration and severity of the loss. The other-than-temporary impairment charges recorded during 2015 and 2014 were reported in other (income) expense, net.
During 2013, the company acquired approximately 16 million shares of CTI BioPharma common stock, which are classified as available-for-sale equity securities, for $27 million. Refer to Note 5 for additional information regarding the CTI BioPharma arrangement.
The company had cumulative unrealized gains on available-for-sale debt securities of less than $1 million as of both December 31, 2015 and 2014.
The following table is a reconciliation of the fair value measurements that use significant unobservable inputs (Level 3), which consists of contingent payments related to acquisitions:
(in millions) |
|
Contingent
|
|
|
Fair value as of December 31, 2013 |
|
$ |
291 |
|
Additions |
|
142 |
|
|
Payments |
|
(12 |
) |
|
Net losses recognized in earnings |
|
124 |
|
|
Currency translation adjustments |
|
(27 |
) |
|
Fair value as of December 31, 2014 |
|
$ |
518 |
|
Separation related adjustment |
|
37 |
|
|
Additions |
|
|
|
|
Payments |
|
(8 |
) |
|
Net gains recognized in earnings |
|
(97 |
) |
|
Currency translation adjustments |
|
(17 |
) |
|
Fair value as of December 31, 2015 |
|
$ |
433 |
|
In 2015, the company recognized a gain of $97 million in other (income) expense, net related to a reduction of the estimated fair value of contingent payment liabilities for certain milestones associated with the acquisitions of OBIZUR, Chatham, and AesRx. Also, the company recorded a separation-
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 10 FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS (Continued)
related adjustment of $37 million in 2015 for contingent payment liabilities related to foreign exchange losses that were not previously allocated to Baxalta in periods prior to the separation.
In 2014, the companys additions related to the contingent payment liabilities associated with the acquisitions of Chatham and AesRx. The net loss recognized in earnings and reported in other (income) expense, net primarily related to an increase in the estimated fair value of contingent payment liabilities associated with the 2013 acquisition of OBIZUR and related assets from Inspiration / Ipsen.
Book Values and Fair Values of Financial Instruments
In addition to the financial instruments that the company is required to recognize at fair value on the consolidated and combined balance sheets, the company has certain financial instruments that are recognized at historical cost or some basis other than fair value. For these financial instruments, the following table provides the values recognized on the consolidated or combined balance sheets and the approximate fair values:
|
|
Book values |
|
Approximate fair values |
|
||||||||
(in millions) |
|
December 31,
|
|
December 31,
|
|
December 31,
|
|
December 31,
|
|
||||
Assets |
|
|
|
|
|
|
|
|
|
||||
Investments |
|
$ |
21 |
|
$ |
31 |
|
$ |
21 |
|
$ |
31 |
|
Liabilities |
|
|
|
|
|
|
|
|
|
||||
Current maturities of lease obligations |
|
3 |
|
|
|
3 |
|
|
|
||||
Long-term debt and lease obligations |
|
$ |
5,265 |
|
$ |
275 |
|
$ |
5,396 |
|
$ |
275 |
|
Investments include certain cost method investments whose fair value is based on Level 3 inputs. The estimated fair value of capital lease obligations is based on Level 2 inputs. The estimated fair values of long-term debt were computed by multiplying price by the notional amount of the respective debt instrument. Price is calculated using the stated terms of the respective debt instrument and yield curves commensurate with the companys credit risk. The discount factors used in the calculations reflect the non-performance risk of the company. The carrying values of the other financial instruments approximate their fair values due to the short-term maturities of most of these assets and liabilities.
During 2015 and 2014, the company recorded $31 million and $64 million of income in other (income) expense, net related to equity method investments, which primarily represented realized gains from funds that sold portfolio companies in both periods, as well as gains from the sale of certain investments in 2015 and 2014.
NOTE 11 COMMITMENTS AND CONTINGENCIES
Operating Lease Commitments
The company leases certain facilities and equipment under operating leases expiring at various dates. The leases generally provide for the company to pay taxes, maintenance, insurance and certain other operating costs of the leased property. Most of the operating leases contain renewal options. Operating lease rent expense was $52 million in 2015, $42 million in 2014 and $40 million in 2013.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 11 COMMITMENTS AND CONTINGENCIES (Continued)
The following table summarizes future minimum operating lease payments:
years ending December 31 (in millions) |
|
2016 |
|
2017 |
|
2018 |
|
2019 |
|
2020 |
|
Thereafter |
|
||||||
Future minimum operating lease payments |
|
$ |
58 |
|
$ |
52 |
|
$ |
46 |
|
$ |
35 |
|
$ |
30 |
|
$ |
161 |
|
Limited Partnership Commitments
The company has unfunded commitments of $79 million as a limited partner in various equity investments as of December 31, 2015.
Indemnifications
During the normal course of business, the company enters into indemnities, commitments and guarantees pursuant to which the company may be required to make payments related to specific transactions. In addition, the company indemnifies its directors and officers for certain losses and expenses upon the occurrence of certain prescribed events. The majority of these indemnities, commitments and guarantees do not provide for any limitation on the maximum potential for future payments that the company could be obligated to make. To help address some of these risks, the company maintains various insurance coverages. Based on experience and evaluation of the agreements, the company does not believe that any significant payments related to its indemnities will occur, and therefore the company has not recorded any associated liabilities, other than for certain tax-related indemnifications described in Note 14.
Other Contingencies
The company has other contingencies associated with its collaborative arrangements, as further discussed in Note 5, and legal contingencies, as further discussed in Note 16.
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS
Shared Baxter Plans Prior to the Separation
Prior to the transfer of net pension and other post-employment benefit (OPEB) plan obligations discussed below and with the exception of certain Austrian defined benefit pension plans, of which Baxalta was the sole sponsor prior to any transfers, the companys employees participated in certain U.S. and international defined benefit pension and OPEB plans sponsored by Baxter. These plans included participants of Baxters other businesses and were accounted for as multiemployer plans in the companys combined financial statements prior to the transfer into newly-created plans sponsored by Baxalta. As a result, no asset or liability was recorded by the company in its combined balance sheets as of December 31, 2014 to recognize the funded status of these plans. The costs of these plans were allocated to the company and recorded in cost of sales, selling, general and administrative expenses and R&D expenses in the combined statements of income. For the Baxter sponsored defined benefit pension and OPEB plans, Baxalta recorded expense of $16 million, $37 million and $45 million for 2015, 2014 and 2013, respectively, relating to Baxalta employees participation in Baxter sponsored plans.
The company has been the sole sponsor for certain Austrian defined benefit plans prior to the separation and has accounted for the Austrian defined benefit plans as single employer plans for the periods presented below.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
Impact of Separation
During the second quarter of 2015, Baxalta assumed certain pension and OPEB obligations and plan assets related to newly-created single employer plans for Baxalta employees, as well as pension obligations and plan assets associated with its employees who participated in certain plans that split following the separation. The company accounted for certain plans with delayed split dates as multiple-employer plans beginning in the second quarter of 2015 because the company was responsible for its employees retiring during the interim period.
The assumed pension obligations related to plans in the United States generally related to only active employees who transferred to Baxalta in connection with the separation. The company generally did not assume obligations associated with retired or otherwise inactive employees in the United States.
Reconciliation of Pension and OPEB Plan Obligations, Assets and Funded Status
The benefit plan information in the table below pertains to all of the companys pension and OPEB plans, both in the United States and in other countries.
|
|
Pension |
|
|
|
|
|
||||||||||||
|
|
U.S. |
|
International |
|
OPEB |
|
||||||||||||
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
||||||
Benefit obligations |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Beginning of period |
|
$ |
|
|
$ |
|
|
$ |
166 |
|
$ |
156 |
|
$ |
|
|
$ |
|
|
Assumption of benefit obligations from Baxter |
|
370 |
|
|
|
283 |
|
|
|
20 |
|
|
|
||||||
Service cost |
|
14 |
|
|
|
19 |
|
6 |
|
1 |
|
|
|
||||||
Interest cost |
|
11 |
|
|
|
5 |
|
5 |
|
|
|
|
|
||||||
Participant contributions |
|
|
|
|
|
2 |
|
|
|
|
|
|
|
||||||
Actuarial (gain)/ loss |
|
(19 |
) |
|
|
4 |
|
33 |
|
(1 |
) |
|
|
||||||
Benefit payments |
|
|
|
|
|
(7 |
) |
(5 |
) |
|
|
|
|
||||||
Settlements |
|
|
|
|
|
(1 |
) |
(3 |
) |
|
|
|
|
||||||
Foreign exchange and other |
|
|
|
|
|
(24 |
) |
(26 |
) |
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
End of period |
|
$ |
376 |
|
$ |
|
|
$ |
447 |
|
$ |
166 |
|
$ |
20 |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Fair value of plan assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Beginning of period |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Assumption of plan assets from Baxter |
|
227 |
|
|
|
128 |
|
|
|
|
|
|
|
||||||
Actual return on plan assets |
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
||||||
Employer contributions |
|
|
|
|
|
12 |
|
8 |
|
|
|
|
|
||||||
Participant contributions |
|
|
|
|
|
2 |
|
|
|
|
|
|
|
||||||
Benefit payments |
|
|
|
|
|
(7 |
) |
(5 |
) |
|
|
|
|
||||||
Settlements |
|
|
|
|
|
(1 |
) |
(3 |
) |
|
|
|
|
||||||
Foreign exchange and other |
|
|
|
|
|
(1 |
) |
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
End of period |
|
220 |
|
|
|
133 |
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Funded status at December 31 |
|
$ |
(156 |
) |
$ |
|
|
$ |
(314 |
) |
$ |
(166 |
) |
$ |
(20 |
) |
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Amounts recognized in the consolidated and combined balance sheets |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Current liability |
|
$ |
|
|
$ |
|
|
$ |
(5 |
) |
$ |
(5 |
) |
$ |
|
|
$ |
|
|
Noncurrent liability |
|
(156 |
) |
|
|
(309 |
) |
(161 |
) |
(20 |
) |
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Net liability recognized at December 31 |
|
$ |
(156 |
) |
$ |
|
|
$ |
(314 |
) |
$ |
(166 |
) |
$ |
(20 |
) |
$ |
|
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
Foreign exchange and other during 2015 includes approximately $9 million of benefit obligations associated with the Austrian plans that were transferred from the company to Baxter. The assumption of benefit obligations and plan assets from Baxter include adjustments recorded during the second half of 2015.
Accumulated Benefit Obligation Information
The pension obligation information in the table above represents the projected benefit obligation (PBO). The PBO incorporates assumptions relating to future compensation levels. The accumulated benefit obligation (ABO) is the same as the PBO except that it includes no assumptions relating to future compensation levels. The ABO for all of the companys U.S. pension plans was $315 million at the December 31, 2015 measurement date. The ABO for all of the companys International pension plans was $343 million and $133 million at the December 31, 2015 and 2014 measurement dates, respectively.
The information in the funded status table above represents the totals for all of the companys pension plans. The following is information relating to the individual plans in the funded status table above that have an ABO in excess of plan assets.
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
||
U.S. |
|
|
|
|
|
||
ABO |
|
$ |
315 |
|
$ |
|
|
Fair value of plan assets |
|
220 |
|
|
|
||
International |
|
|
|
|
|
||
ABO |
|
$ |
324 |
|
$ |
133 |
|
Fair value of plan assets |
|
112 |
|
|
|
The following is information relating to the individual plans in the funded status table above that have a PBO in excess of plan assets (many of which also have an ABO in excess of assets, and are therefore also included in the table directly above).
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
||
U.S. |
|
|
|
|
|
||
PBO |
|
$ |
376 |
|
$ |
|
|
Fair value of plan assets |
|
220 |
|
|
|
||
International |
|
|
|
|
|
||
PBO |
|
$ |
447 |
|
$ |
166 |
|
Fair value of plan assets |
|
133 |
|
|
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
Expected Net Pension and OPEB Plan Payments for the Next 10 Years
(in millions) |
|
U.S.
|
|
International
|
|
OPEB |
|
|||
2016 |
|
$ |
3 |
|
$ |
13 |
|
$ |
|
|
2017 |
|
5 |
|
15 |
|
|
|
|||
2018 |
|
7 |
|
15 |
|
|
|
|||
2019 |
|
9 |
|
16 |
|
|
|
|||
2020 |
|
11 |
|
17 |
|
|
|
|||
2021 through 2025 |
|
89 |
|
104 |
|
3 |
|
|||
|
|
|
|
|
|
|
|
|||
Total expected net benefit payments for next 10 years |
|
$ |
124 |
|
$ |
180 |
|
$ |
3 |
|
The expected net benefit payments above reflect the companys share of the total net benefits expected to be paid from the plans assets (for funded plans) or from the companys assets (for unfunded plans). The federal subsidies relating to the Medicare Prescription Drug, Improvement and Modernization Act are not expected to be significant.
Amounts Recognized in AOCI
The pension and OPEB plans gains or losses, prior service costs or credits, and transition assets or obligations not yet recognized in net periodic benefit cost are recognized on a net-of-tax basis in AOCI and will be amortized from AOCI to net periodic benefit cost in the future.
The following is a summary of the pre-tax losses included in AOCI at December 31, 2015 and December 31, 2014.
(in millions) |
|
U.S.
|
|
International
|
|
OPEB |
|
|||
Actuarial loss |
|
$ |
102 |
|
$ |
154 |
|
$ |
3 |
|
Prior service credit and transition obligation |
|
|
|
1 |
|
(14 |
) |
|||
|
|
|
|
|
|
|
|
|||
Total pre-tax loss recognized in AOCI at December 31, 2015 |
|
$ |
102 |
|
$ |
155 |
|
$ |
(11 |
) |
Actuarial loss |
|
$ |
|
|
$ |
70 |
|
$ |
|
|
Prior service credit and transition obligation |
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Total pre-tax loss recognized in AOCI at December 31, 2014 |
|
$ |
|
|
$ |
70 |
|
$ |
|
|
During the second quarter of 2015, the company assumed approximately $200 million of pre-tax losses included in AOCI in connection with the separation.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
Refer to Note 13 for the net-of-tax balances included in AOCI as of each of the year-end dates. The following is a summary of the net-of-tax amounts recorded in OCI relating to pension and OPEB plans.
|
|
U.S Pension
|
|
International
|
|
||||||||||||||
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
2015 |
|
2014 |
|
2013 |
|
||||||
Gain (loss) arising during the year, net of tax expense (benefit) for U.S. plans of $3 in 2015 and $0 in 2014 and 2013 and for international plans of $6 in 2015, ($6) in 2014 and $1 in 2013 |
|
$ |
5 |
|
$ |
|
|
$ |
|
|
$ |
(7 |
) |
$ |
(4 |
) |
$ |
(11 |
) |
Amortization of loss to earnings, net of tax expense for U.S. plans of $2 in 2015 and $0 in 2014 and 2013 and for international plans of $3 in 2015, $1 in 2014, and $1 in 2013 |
|
5 |
|
|
|
|
|
8 |
|
3 |
|
4 |
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Pension and other employee benefits gain (loss) |
|
$ |
10 |
|
$ |
|
|
$ |
|
|
$ |
1 |
|
$ |
(1 |
) |
$ |
(7 |
) |
Amounts Expected to be Amortized from AOCI to Net Periodic Benefit Cost in 2016
With respect to the AOCI balance at December 31, 2015, the following is a summary of the pre-tax amounts expected to be amortized to net periodic benefit cost in 2016.
(in millions) |
|
U.S.
|
|
International
|
|
OPEB |
|
|||
Actuarial loss |
|
$ |
8 |
|
$ |
10 |
|
$ |
|
|
Prior service credit and transition obligation |
|
|
|
|
|
(1 |
) |
|||
|
|
|
|
|
|
|
|
|||
Total pre-tax amount expected to be amortized from AOCI to net pension and OPEB cost in 2016 |
|
$ |
8 |
|
$ |
10 |
|
$ |
(1 |
) |
Net Periodic Benefit Cost
|
|
U.S. Pension |
|
International
|
|
OPEB |
|
|||||||||||||||||||||
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
2015 |
|
2014 |
|
2013 |
|
2015 |
|
2014 |
|
2013 |
|
|||||||||
Net periodic benefit cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Service cost |
|
$ |
14 |
|
$ |
|
|
$ |
|
|
$ |
19 |
|
$ |
6 |
|
$ |
6 |
|
$ |
1 |
|
$ |
|
|
$ |
|
|
Interest cost |
|
11 |
|
|
|
|
|
5 |
|
5 |
|
5 |
|
|
|
|
|
|
|
|||||||||
Expected return on plan assets |
|
(11 |
) |
|
|
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
|||||||||
Amortization of net losses and other deferred amounts |
|
8 |
|
|
|
|
|
10 |
|
3 |
|
4 |
|
|
|
|
|
|
|
|||||||||
Settlement losses |
|
|
|
|
|
|
|
|
|
1 |
|
1 |
|
|
|
|
|
|
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Net periodic benefit cost |
|
$ |
22 |
|
$ |
|
|
$ |
|
|
$ |
30 |
|
$ |
15 |
|
$ |
16 |
|
$ |
1 |
|
$ |
|
|
$ |
|
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
Weighted-Average Assumptions Used in Determining Benefit Obligations at the Measurement Date
|
|
U.S. Pension |
|
International
|
|
OPEB |
|
||||||
|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
Discount rate |
|
4.60 |
% |
n/a |
|
1.50 |
% |
2.00 |
% |
4.65 |
% |
n/a |
|
Rate of compensation increase |
|
3.80 |
% |
n/a |
|
3.20 |
% |
3.50 |
% |
n/a |
|
n/a |
|
Annual rate of increase in the per-capita cost |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
6.50 |
% |
n/a |
|
Rate decreased to |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
5.00 |
% |
n/a |
|
by the year ended |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
2022 |
|
n/a |
|
The assumptions above, which were used in calculating the December 31, 2015 measurement date benefit obligations, will be used in the calculation of net periodic benefit cost in 2016.
Weighted-Average Assumptions Used in Determining Net Periodic Benefit Cost
|
|
U.S. Pension |
|
International Pension |
|
OPEB |
|
||||||||||||
|
|
2015 |
|
2014 |
|
2013 |
|
2015 |
|
2014 |
|
2013 |
|
2015 |
|
2014 |
|
2013 |
|
Discount rate |
|
4.30 |
% |
n/a |
|
n/a |
|
1.11 |
% |
3.30 |
% |
3.25 |
% |
4.30 |
% |
n/a |
|
n/a |
|
Expected return on plan assets |
|
7.25 |
% |
n/a |
|
n/a |
|
5.31 |
% |
n/a |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
Rate of compensation increase |
|
3.80 |
% |
n/a |
|
n/a |
|
3.41 |
% |
3.50 |
% |
3.50 |
% |
n/a |
|
n/a |
|
n/a |
|
Annual rate of increase in the per-capita cost |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
6.50 |
% |
n/a |
|
n/a |
|
Rate decreased to |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
5.00 |
% |
n/a |
|
n/a |
|
by the year ended |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
2022 |
|
n/a |
|
n/a |
|
The company establishes the expected return on plan assets assumption primarily based on a review of historical compound average asset returns, both company-specific and relating to the broad market (based on the companys asset allocation), as well as an analysis of current market and economic information and future expectations. The company plans to use a 7.00% assumption for its funded U.S. plan for 2016.
Effect of a One-Percent Change in Assumed Healthcare Cost Trend Rate on the OPEB Plan
|
|
One
|
|
One
|
|
||
years ended December 31 (in millions) |
|
2015 |
|
2015 |
|
||
Effect on total of service and interest cost components of OPEB cost |
|
$ |
|
|
$ |
|
|
Effect on OPEB obligation |
|
$ |
3 |
|
$ |
(3 |
) |
Pension Plan Assets
A benefits committee of members of senior management is responsible for supervising, monitoring and evaluating the invested assets of the companys funded pension plans. The benefits committee, which meets at least quarterly, abides by documented policies and procedures relating to investment goals, targeted asset allocations, risk management practices, allowable and prohibited investment
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
holdings, diversification, use of derivatives, the relationship between plan assets and benefit obligations, and other relevant factors and considerations. In the United States, the benefits committee has hired an outsourced chief investment officer (oCIO) provider, Goldman Sachs Asset Management, to perform the day-to-day management of pension assets.
The benefits committees documented policies and procedures include the following:
· Ability to pay all benefits when due;
· Targeted long-term performance expectations relative to applicable market indices, such as Standard & Poors, Russell, MSCI EAFE, and other indices;
· Targeted asset allocation percentage ranges (summarized below), and periodic reviews of these allocations;
· Specified investment holding and transaction prohibitions (for example, private placements or other restricted securities, securities that are not traded in a sufficiently active market, short sales, certain derivatives, commodities and margin transactions);
· Specified portfolio percentage limits on holdings in a single corporate or other entity (generally 5%, except for holdings in U.S. government or agency securities);
· Specified average credit quality for the fixed-income securities portfolio (at least A- by Standard & Poors or A3 by Moodys);
· Specified portfolio percentage limits on foreign holdings; and
· Periodic monitoring of oCIO performance and adherence to the benefits committees policies.
Plan assets are invested using a total return investment approach whereby a mix of equity securities, debt securities and other investments are used to preserve asset values, diversify risk and exceed the planned benchmark investment return. Investment strategies and asset allocations are based on consideration of plan liabilities, the plans funded status and other factors, such as the plans demographics and liability durations. Investment performance is reviewed by the benefits committee on a quarterly basis and asset allocations are reviewed at least annually.
Plan assets are managed in a balanced equity and fixed income portfolio. The target allocations for plan assets are 75 percent in an equity portfolio and 25 percent in a fixed income portfolio. The documented policy includes an allocation range based on each individual investment type within the major portfolios that allows for a variance from the target allocations of approximately five percentage points. The equity portfolio may include common stock of U.S. and international companies, common/collective trust funds, mutual funds, hedge funds and real asset investments. The fixed income portfolio may include cash, money market funds with an original maturity of three months or less, U.S. and foreign government and governmental agency issues, common/collective trust funds, corporate bonds, municipal securities, derivative contracts and asset-backed securities.
While the benefits committee provides oversight over plan assets for U.S. and international plans, the summary above is specific to the plans in the United States. The plan assets for international plans are managed and allocated by the entities in each country, with input and oversight provided by the benefits committee.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
The following tables summarize the bases used to measure the pension plan assets and liabilities that are carried at fair value on a recurring basis for the U.S. funded plan.
|
|
|
|
Basis of fair value measurement |
|
||||||||
(in millions) |
|
Balance at
|
|
Quoted
|
|
Significant
|
|
Significant
|
|
||||
Assets |
|
|
|
|
|
|
|
|
|
||||
Fixed income |
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
6 |
|
$ |
|
|
$ |
6 |
|
$ |
|
|
Common/collective trust funds |
|
54 |
|
|
|
54 |
|
|
|
||||
Equity |
|
|
|
|
|
|
|
|
|
||||
Common/collective trust funds |
|
149 |
|
19 |
|
130 |
|
|
|
||||
Hedge fund |
|
11 |
|
|
|
11 |
|
|
|
||||
Fair value of pension plan assets |
|
$ |
220 |
|
$ |
19 |
|
$ |
201 |
|
$ |
|
|
The following tables summarize the bases used to measure the pension plan assets and liabilities that are carried at fair value on a recurring basis for the international funded plans.
|
|
|
|
Basis of fair value measurement |
|
||||||||
(in millions) |
|
Balance at
|
|
Quoted
|
|
Significant
|
|
Significant
|
|
||||
Assets |
|
|
|
|
|
|
|
|
|
||||
Fixed income |
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
8 |
|
$ |
8 |
|
$ |
|
|
$ |
|
|
Government agency issues |
|
1 |
|
1 |
|
|
|
|
|
||||
Corporate bonds |
|
29 |
|
29 |
|
|
|
|
|
||||
Mutual Funds |
|
35 |
|
35 |
|
|
|
|
|
||||
Equity |
|
|
|
|
|
|
|
|
|
||||
Common stock: |
|
|
|
|
|
|
|
|
|
||||
Large cap |
|
17 |
|
17 |
|
|
|
|
|
||||
Mid cap |
|
1 |
|
1 |
|
|
|
|
|
||||
Small cap |
|
|
|
|
|
|
|
|
|
||||
Total common stock |
|
18 |
|
18 |
|
|
|
|
|
||||
Mutual funds |
|
25 |
|
25 |
|
|
|
|
|
||||
Real Estate funds |
|
10 |
|
8 |
|
2 |
|
|
|
||||
Other holdings |
|
7 |
|
|
|
7 |
|
|
|
||||
Fair value of pension plan assets |
|
$ |
133 |
|
$ |
124 |
|
$ |
9 |
|
$ |
|
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
The assets and liabilities of the companys pension plans are valued using the following valuation methods:
Investment category |
|
Valuation methodology |
Cash and cash equivalents |
|
These largely consist of a short-term investment fund, U.S. dollars and foreign currency. The fair value of the short-term investment fund is based on the net asset value |
|
|
|
Government agency issues |
|
Values are based quoted prices in an active market |
|
|
|
Corporate bonds |
|
Values are based on the valuation date in an active market |
|
|
|
Common stock |
|
Values are based on the closing prices on the valuation date in an active market on national and international stock exchanges |
|
|
|
Mutual funds |
|
Values are based on the net asset value of the units held in the respective fund which are obtained from national and international exchanges |
|
|
|
Common/collective trust funds |
|
Values are based on the net asset value of the units held at year end |
|
|
|
Real estate funds |
|
The value of these assets are either determined by the net asset value of the units held in the respective fund which are obtained from national and international exchanges or based on the net asset value of the underlying assets of the fund provided by the fund manager |
|
|
|
Other holdings |
|
The value of these assets vary by investment type and are primarily based on reputable pricing vendors that typically use pricing matrices or models |
Expected Pension and OPEB Plan Funding
The companys funding policy for its pension plans is to contribute amounts sufficient to meet legal funding requirements, plus any additional amounts that the company may determine to be appropriate considering the funded status of the plans, tax deductibility, the cash flows generated by the company, and other factors. Volatility in the global financial markets could have an unfavorable impact on future funding requirements. The company has no obligation to fund its principal plans in the United States in 2016. The company continually reassesses the amount and timing of any discretionary contributions. The company expects to make cash contributions to its pension plans of at
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 12 RETIREMENT AND OTHER BENEFIT PROGRAMS (Continued)
least $9 million in 2016, primarily related to the companys international plans. The company expects to have net cash outflows relating to its OPEB plan of less than $1 million in 2016.
The table below details the funded status percentage of the companys pension plans as of December 31, 2015, including certain plans that are unfunded in accordance with the guidelines of the companys funding policy outlined above.
|
|
United States |
|
International |
|
|
|
|||||||||
as of December 31, 2015 (in millions) |
|
Qualified
|
|
Nonqualified
|
|
Funded
|
|
Unfunded
|
|
Total |
|
|||||
Fair value of plan assets |
|
$ |
220 |
|
n/a |
|
$ |
133 |
|
n/a |
|
$ |
353 |
|
||
PBO |
|
349 |
|
$ |
27 |
|
281 |
|
$ |
166 |
|
823 |
|
|||
Funded status percentage |
|
63 |
% |
n/a |
|
47 |
% |
n/a |
|
43 |
% |
|||||
U.S. Defined Contribution Plan
Most U.S. employees are eligible to participate in a qualified defined contribution plan. Company contributions were $21 million in 2015, $20 million in 2014 and $16 million in 2013.
NOTE 13 ACCUMULATED OTHER COMPREHENSIVE INCOME
The following is a net-of-tax summary of the changes in AOCI by component for the years ended 2015 and 2014.
(in millions) |
|
Foreign
|
|
Pension and
|
|
Available-
|
|
Hedging
|
|
Total |
|
|||||
Gains (losses) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance as of December 31, 2014 |
|
$ |
(387 |
) |
$ |
(52 |
) |
$ |
7 |
|
$ |
(1 |
) |
$ |
(433 |
) |
Other comprehensive (loss) income before reclassifications |
|
(362 |
) |
(2 |
) |
(9 |
) |
36 |
|
(337 |
) |
|||||
Amounts reclassified from AOCI(a) |
|
|
|
13 |
|
10 |
|
(30 |
) |
(7 |
) |
|||||
Net other comprehensive (loss) income |
|
(362 |
) |
11 |
|
1 |
|
6 |
|
(344 |
) |
|||||
Separation-related adjustments |
|
390 |
|
(145 |
) |
9 |
|
28 |
|
282 |
|
|||||
Balance as of December 31, 2015 |
|
$ |
(359 |
) |
$ |
(186 |
) |
$ |
17 |
|
$ |
33 |
|
$ |
(495 |
) |
(in millions) |
|
Foreign
|
|
Pension and
|
|
Available-
|
|
Hedging
|
|
Total |
|
|||||
Gains (losses) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance as of December 31, 2013 |
|
$ |
|
|
$ |
(51 |
) |
$ |
(13 |
) |
$ |
|
|
$ |
(64 |
) |
Other comprehensive (loss) income before reclassifications |
|
(387 |
) |
(4 |
) |
(20 |
) |
(1 |
) |
(412 |
) |
|||||
Amounts reclassified from AOCI(a) |
|
|
|
3 |
|
40 |
|
|
|
43 |
|
|||||
Net other comprehensive (loss) income |
|
(387 |
) |
(1 |
) |
20 |
|
(1 |
) |
(369 |
) |
|||||
Balance as of December 31, 2014 |
|
$ |
(387 |
) |
$ |
(52 |
) |
$ |
7 |
|
$ |
(1 |
) |
$ |
(433 |
) |
(a) See table below for details about these reclassifications.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 13 ACCUMULATED OTHER COMPREHENSIVE INCOME (Continued)
The net separation-related adjustments during 2015 primarily related to the assumption of deferred hedging gains and deferred pension losses during the second quarter of 2015, as well as differences between AOCI transferred to Baxalta as a result of the separation and AOCI reported in the companys combined balance sheet as of June 30, 2015.
The following is a summary of the amounts reclassified from AOCI to net income during the years ended December 31, 2015 and 2014.
|
|
Amounts reclassified from AOCI(a) |
|
||||||
(in millions) |
|
2015 |
|
2014 |
|
Location of impact in
|
|
||
Amortization of pension and other employee benefits |
|
|
|
|
|
|
|
||
Actuarial losses and other |
|
$ |
(18 |
) |
$ |
(4 |
) |
(b) |
|
|
|
(18 |
) |
(4 |
) |
Total before tax |
|
||
|
|
5 |
|
1 |
|
Tax benefit |
|
||
|
|
$ |
(13 |
) |
$ |
(3 |
) |
Net of tax |
|
Gains (losses) on hedging activities |
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
$ |
46 |
|
$ |
|
|
Cost of sales |
|
Interest rate contracts |
|
1 |
|
|
|
Net interest expense |
|
||
|
|
47 |
|
|
|
Total before tax |
|
||
|
|
(17 |
) |
|
|
Tax expense |
|
||
|
|
$ |
30 |
|
$ |
|
|
Net of tax |
|
Gains (losses) on available-for-sale securities |
|
|
|
|
|
|
|
||
Other-than-temporary impairment of available-for-sale equity security |
|
$ |
(14 |
) |
$ |
(45 |
) |
Other (income) expense, net |
|
Gain on available-for-sale equity security |
|
3 |
|
|
|
Other (income) expense, net |
|
||
|
|
(11 |
) |
(45 |
) |
Total before tax |
|
||
|
|
1 |
|
5 |
|
Tax benefit |
|
||
|
|
(10 |
) |
(40 |
) |
Net of tax |
|
||
Total reclassification for the period |
|
$ |
7 |
|
$ |
(43 |
) |
Total net of tax |
|
(a) Amounts in parentheses indicate reductions to net income.
(b) These AOCI components are included in the computation of net periodic benefit cost disclosed in Note 12.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 14 INCOME TAXES
Income from Continuing Operations Before Income Tax Expense by Category
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
United States |
|
$ |
618 |
|
$ |
728 |
|
$ |
881 |
|
International |
|
580 |
|
804 |
|
732 |
|
|||
Income before income taxes |
|
$ |
1,198 |
|
$ |
1,532 |
|
$ |
1,613 |
|
Income Taxes on Continuing Operations
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Current |
|
|
|
|
|
|
|
|||
United States |
|
$ |
283 |
|
$ |
273 |
|
$ |
326 |
|
International |
|
52 |
|
5 |
|
42 |
|
|||
Current income tax expense |
|
335 |
|
278 |
|
368 |
|
|||
Deferred |
|
|
|
|
|
|
|
|||
United States |
|
(52 |
) |
27 |
|
(40 |
) |
|||
International |
|
(13 |
) |
41 |
|
(3 |
) |
|||
Deferred income tax (benefit) expense |
|
(65 |
) |
68 |
|
(43 |
) |
|||
Income tax expense |
|
$ |
270 |
|
$ |
346 |
|
$ |
325 |
|
Income Tax Expense Reconciliation
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Income tax expense at U.S. statutory rate |
|
$ |
420 |
|
$ |
536 |
|
$ |
565 |
|
Tax incentives |
|
(112 |
) |
(111 |
) |
(146 |
) |
|||
Foreign taxes less than U.S. rate |
|
(48 |
) |
(98 |
) |
(89 |
) |
|||
State and local taxes |
|
15 |
|
26 |
|
32 |
|
|||
Branded Prescription Drug Fee |
|
10 |
|
20 |
|
7 |
|
|||
Research and Orphan Drug Credit |
|
(7 |
) |
(7 |
) |
(10 |
) |
|||
Domestic manufacturing deduction |
|
(14 |
) |
|
|
|
|
|||
Tax contingencies |
|
12 |
|
(19 |
) |
(30 |
) |
|||
Other items |
|
(6 |
) |
(1 |
) |
(4 |
) |
|||
Income tax expense |
|
$ |
270 |
|
$ |
346 |
|
$ |
325 |
|
The effective income tax rate for continuing operations was 22.5% in 2015, 22.6% in 2014, and 20.1% in 2013. As detailed in the income tax expense reconciliation table above, the companys effective tax rate differs from the U.S. federal statutory rate each year due to certain operations that are subject to tax incentives, state and local taxes, and foreign taxes that are different than the U.S. federal statutory rate. In addition, the effective tax rate can be impacted each period by discrete factors and events.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 14 INCOME TAXES (Continued)
The benefit from foreign operations reflects the impact of lower income tax rates in locations outside the United States, as well as tax exemptions and incentives in Switzerland, Singapore, and other foreign tax jurisdictions. Earnings outside the United States of $77 million incurred prior to the separation are not deemed to be indefinitely reinvested and have an associated income tax of $9 million. Management intends to continue to reinvest all other historical and future earnings in several jurisdictions outside of the United States indefinitely, and therefore has not recognized U.S. income tax expense on these earnings.
The company has received tax incentives in certain taxing jurisdictions outside the United States. The financial impact of the reductions as compared to the statutory tax rates is indicated in the income tax expense reconciliation table above. The tax reductions as compared to the local statutory rate favorably impacted earnings from continuing operations per diluted share by $0.17 in 2015, $0.16 in 2014 and $0.21 in 2013.
Deferred Tax Assets and Liabilities
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
||
Deferred tax assets |
|
|
|
|
|
||
Compensation and retirement benefits |
|
$ |
213 |
|
$ |
92 |
|
Tax credits and net operating losses |
|
40 |
|
3 |
|
||
Capital lease obligations |
|
116 |
|
|
|
||
Accrued expenses |
|
123 |
|
198 |
|
||
Valuation allowances |
|
(4 |
) |
|
|
||
Total deferred tax assets |
|
488 |
|
293 |
|
||
Deferred tax liabilities |
|
|
|
|
|
||
Subsidiaries unremitted earnings |
|
(9 |
) |
(34 |
) |
||
Fixed assets |
|
(313 |
) |
(258 |
) |
||
Intangible assets |
|
(148 |
) |
(78 |
) |
||
Other items |
|
(4 |
) |
31 |
|
||
Total deferred tax liabilities |
|
(474 |
) |
(339 |
) |
||
Net deferred tax asset |
|
$ |
14 |
|
$ |
(46 |
) |
In 2015, certain prior period amounts were reclassified to conform with the current period presentation, primarily in connection with the classification of prepaid taxes associated with deferred intercompany profit in inventory from the deferred taxes rollforward. The company has elected to adopt ASU No. 2015-17, as further discussed in Note 2, starting with the period ending December 31, 2015 and retroactively applying to the balances as of December 31, 2014. The company has prepared these financial statements in accordance with the new guidance requiring that all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet. Additional reclassifications were made with respect to prior period deferred items to better identify the true nature of these items and to conform with the current period presentation. The adoption of ASU No. 2015-17 has the effect of reducing short-term deferred income taxes by $215 million, increasing other long-term assets by $14 million, reducing short-term liabilities by
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 14 INCOME TAXES (Continued)
$4 million and reducing other long-term liabilities by $197 million for the year ended December 31, 2014.
As of December 31, 2015, the company has no material loss or credit carryforwards for U.S. or state tax purposes. As of December 31, 2015, the company had foreign operation loss carryforwards of $50 million and no foreign tax credit carryforwards. The company maintains no material valuation allowances to reduce deferred tax assets because the company believes it is more likely than not that these assets will be fully realized. The company evaluates the need for valuation allowances on a continuous basis, and as circumstances change, the need for a valuation allowance against deferred tax assets may arise.
Deferred income taxes have not been provided on approximately $6.4 billion of the undistributed earnings of foreign subsidiaries as these earnings have been indefinitely reinvested for continued use in foreign operations. If these undistributed earnings are repatriated to the U.S. in the foreseeable future, the company would incur an income tax expense of approximately $2.2 billion, excluding any potential foreign tax credits or future changes in tax law.
Unrecognized Tax Benefits
The following is a reconciliation of the companys unrecognized tax benefits for the years ended December 31, 2015, 2014 and 2013.
as of and for the years ended (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Balance at beginning of the year |
|
$ |
65 |
|
$ |
81 |
|
$ |
259 |
|
Increase associated with tax positions taken during the current year |
|
17 |
|
2 |
|
7 |
|
|||
Decrease associated with tax positions taken during a prior year |
|
|
|
(4 |
) |
|
|
|||
Separation related adjustment |
|
(60 |
) |
|
|
|
|
|||
Settlements |
|
(5 |
) |
(6 |
) |
(179 |
) |
|||
Decrease associated with lapses in statutes of limitations |
|
|
|
(8 |
) |
(6 |
) |
|||
Balance at end of the year |
|
$ |
17 |
|
$ |
65 |
|
$ |
81 |
|
Baxalta and Baxter entered into a tax sharing agreement, effective on the date of separation, which employs a tracing approach to determine which company is liable for certain pre-separation income tax items. If a liability arises and is attributable to the Bioscience business, the liability would be allocated to Baxalta. If a liability arises and is attributable to the Medical Device, Renal or Biosurgery businesses, it would be allocated to Baxter.
The table above reflects a reduction of $60 million related to tax periods prior to the separation for which Baxter is the primary obligor. However, under U.S. Treasury Regulations, each member of a consolidated group is jointly and severally liability for the U.S. federal income tax liability of each other member of the consolidated group. Accordingly, with respect to periods in which Baxalta was included in the Baxter consolidated group, Baxalta could be liable to the U.S. government for any U.S. federal income tax liability tax incurred by the consolidated group, to the extent not discharged by any other member.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 14 INCOME TAXES (Continued)
Baxalta will be directly responsible for tax contingencies and related interest and penalties for its newly formed legal entities for periods after separation or in instances where an existing entity was transferred to Baxalta upon separation. As a result, Baxalta has continued to account for these tax contingencies.
If recognized, the net amount of contingent tax liabilities that would impact the companys effective tax rate is $17 million. The company does not expect that it is reasonably possible that any of its uncertain tax liability positions will be settled in the next twelve months. The company believes adequate provision has been made for all income tax uncertainties. Baxalta recognizes accrued interest and penalties related to uncertain tax positions in income tax expense. The amounts expensed and the liabilities accrued are immaterial as of and for the year ended December 31, 2015. Uncertain tax positions are included as a long-term liability on the consolidated balance sheets.
In the normal course of business, the company may be audited by federal, state and foreign tax authorities, and may be periodically challenged regarding the amount of taxes due. As of December 31, 2015, Baxalta entities were not subject to any ongoing income tax audits.
NOTE 15 SHARE-BASED COMPENSATION
2015 Baxalta Incentive Plan
In connection with the separation, the company adopted the 2015 Baxalta Incorporated Incentive Plan which provides for the assumption of certain awards granted under the Baxter incentive stock programs and provides for additional shares of common stock available for issuance with respect to awards for participants. The 2015 Baxalta Incorporated Incentive Plan initially provided for 91 million shares of common stock for issuance with respect to awards for participants. At December 31, 2015, approximately 39 million shares were available for future awards.
Employee Stock Purchase Plan
Nearly all employees are eligible to participate in the companys employee stock purchase plan. The employee purchase price is 85% of the closing market price on the purchase date. The plan is considered compensatory and related expense recorded by the company was immaterial. The employee stock purchase plan provided for 3 million shares of common stock available for issuance to eligible participants, of which approximately 2.6 million shares were available for future awards as of December 31, 2015.
During 2015, the company issued approximately 0.4 million shares under the current employee stock purchase plan. The number of shares under subscription at December 31, 2015 totaled approximately 1 million.
Impact of Separation from Baxter
Prior to the separation, Baxalta employees participated in Baxters incentive stock program and Baxalta recorded costs in cost of sales, selling, general and administrative expenses and R&D expenses for its employees participation in the program. In connection with the separation, outstanding Baxter equity awards granted prior to January 1, 2015 and held by Baxter or Baxalta employees were adjusted into both Baxter and Baxalta equity awards. Awards granted after January 1, 2015 and certain awards granted during 2014 were adjusted entirely into corresponding awards of either Baxter or Baxalta,
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 15 SHARE-BASED COMPENSATION (Continued)
based on which company would employ the holder following the separation. The value of the combined Baxter and Baxalta stock-based awards after the separation was designed to generally preserve the intrinsic value and the fair value of the award immediately prior to separation. In periods following the separation, Baxalta records share-based compensation costs relating to its employees Baxalta and Baxter equity awards.
Share-Based Compensation Expense
The table presents share-based compensation expense by statement of income line item.
(in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Cost of sales |
|
$ |
10 |
|
$ |
8 |
|
$ |
8 |
|
Selling, general and administrative expense |
|
42 |
|
16 |
|
12 |
|
|||
Research and development expenses |
|
10 |
|
7 |
|
6 |
|
|||
Total share-based compensation expense |
|
$ |
62 |
|
$ |
31 |
|
$ |
26 |
|
The related tax benefit recognized was $18 million in 2015, $10 million in 2014 and $9 million in 2013.
Stock Options
Stock options have been granted to employees and non-employee directors with exercise prices at least equal to 100% of the companys share price on the date of grant. Stock options typically have a contractual term of 10 years. The grant-date fair value, adjusted for estimated forfeitures, is recognized as expense on a straight-line basis over the substantive vesting period.
Stock options granted to employees prior to the separation generally vest in one-third increments over a three-year period. In July 2015, the company made a one-time grant totaling 1.6 million stock options to 5 senior executives that cliff-vest 5 years from the grant date. Stock options granted to non-employee directors generally cliff-vest one year from the grant date (collectively, stock options with service conditions).
In December 2015, the company granted 2.6 million stock options with both a market based and service condition to certain employees (stock options with service and market conditions). These options vest in 2 years if the companys share price remains at or above a specified price target for 20 consecutive days during a 2 year performance period.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 15 SHARE-BASED COMPENSATION (Continued)
Post-Separation Valuation Assumptions
The weighted-average Black-Scholes assumptions used in estimating the fair value of stock options with service conditions granted in 2015 by Baxalta following the separation, along with the weighted-average grant-date fair values, were as follows:
years ended December 31 (in millions) |
|
2015 |
|
|
Expected volatility |
|
31 |
% |
|
Expected life (in years) |
|
6.8 |
|
|
Risk-free interest rate |
|
2.1 |
% |
|
Dividend yield |
|
0.9 |
% |
|
Fair value per stock option |
|
$ |
10 |
|
The stock-options with service and market conditions granted during December 2015 were valued using a Monte Carlo model, with assumptions as follows:
years ended December 31 (in millions) |
|
2015 |
|
|
Expected volatility |
|
30 |
% |
|
Expected life (in years) |
|
6.0 |
|
|
Risk-free interest rate |
|
2.2 |
% |
|
Dividend yield |
|
0.8 |
% |
|
Fair value per stock option |
|
$ |
6 |
|
Pre-Separation Valuation Assumptions
The weighted-average Black-Scholes assumptions used in estimating the fair value of stock options granted by Baxter prior to the separation during each year, along with the weighted-average grant-date fair values, were as follows:
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Expected volatility |
|
20 |
% |
23 |
% |
25 |
% |
|||
Expected life (in years) |
|
5.5 |
|
5.5 |
|
5.5 |
|
|||
Risk-free interest rate |
|
1.7 |
% |
1.7 |
% |
0.9 |
% |
|||
Dividend yield |
|
3.0 |
% |
2.8 |
% |
2.6 |
% |
|||
Fair value per stock option |
|
$ |
9 |
|
$ |
11 |
|
$ |
12 |
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 15 SHARE-BASED COMPENSATION (Continued)
Option Activity and Weighted-Average Unrecognized Expense
A summary of Baxalta stock option activity held by both Baxalta and Baxter employees for the period following the separation is presented below.
(options and aggregate intrinsic values in thousands) |
|
Options |
|
Weighted-
|
|
Weighted-
|
|
Aggregate
|
|
||
Options converted on July 1, 2015 in connection with the separation |
|
35,199 |
|
$ |
28.95 |
|
|
|
|
|
|
Granted |
|
4,937 |
|
33.16 |
|
|
|
|
|
||
Exercised |
|
(1,842 |
) |
27.02 |
|
|
|
|
|
||
Forfeited |
|
(518 |
) |
32.03 |
|
|
|
|
|
||
Expired |
|
(66 |
) |
32.02 |
|
|
|
|
|
||
Outstanding at December 31, 2015 |
|
37,710 |
|
$ |
29.55 |
|
6.6 |
|
$ |
357,376 |
|
Vested or expected to vest as of December 31, 2015 |
|
36,621 |
|
$ |
29.46 |
|
6.5 |
|
$ |
350,508 |
|
Exercisable at December 31, 2015 |
|
19,562 |
|
$ |
26.98 |
|
4.5 |
|
$ |
235,652 |
|
The total intrinsic value of Baxalta stock options exercised by both Baxter and Baxalta employees following the separation was $17 million during 2015.
As of December 31, 2015, the unrecognized compensation cost related to all unvested Baxter and Baxalta stock options held by Baxaltas employees of $60 million is expected to be recognized as expense over a weighted-average period of 2.1 years.
RSUs
RSUs have been granted to employees and non-employee directors. RSUs granted to employees generally vest in one-third increments over a three-year period and RSUs granted to non-employee directors generally cliff-vest one year from the grant date. The grant-date fair value, adjusted for estimated forfeitures, is recognized as expense on a straight-line basis over the substantive vesting period. The fair value of RSUs is determined based on the number of shares granted and the quoted price of the companys common stock on the date of grant.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 15 SHARE-BASED COMPENSATION (Continued)
A summary of Baxalta RSU activity held by both Baxalta and Baxter employees for the period following the separation is presented below:
(share units in thousands) |
|
Share
|
|
Weighted-
|
|
|
Nonvested RSUs converted on July 1, 2015 in connection with the separation |
|
2,955 |
|
$ |
31.98 |
|
Granted |
|
671 |
|
33.34 |
|
|
Vested |
|
(119 |
) |
30.20 |
|
|
Forfeited |
|
(117 |
) |
32.06 |
|
|
Nonvested RSUs at December 31, 2015 |
|
3,390 |
|
$ |
32.30 |
|
(1) The weighted-average grant date fair value has been adjusted for the impact of the separation
The weighted-average grant date fair value of RSUs granted in 2015 following the separation was $33.34. The fair value of RSUs vested in 2015 following the separation was $4 million.
As of December 31, 2015, the unrecognized compensation cost related to all unvested Baxalta or Baxter RSUs held by Baxaltas employees of $54 million is expected to be recognized as expense over a weighted-average period of 2.1 years.
PSUs
Prior to the separation, Baxter granted certain company employees PSUs that vest based on return on invested capital (ROIC) performance or market conditions. The vesting condition for ROIC PSUs is set at the beginning of each year for each tranche of the award during the three-year service period. Compensation cost for the ROIC PSUs was measured based on the fair value of the awards on the date the vesting terms for each tranche of the award are established and the quoted price of Baxter common on the grant date for each tranche of the award. The compensation cost for these PSUs is adjusted at each reporting date to reflect the estimated probability of achieving the vesting condition.
The fair value of PSUs based on market conditions was determined using a Monte Carlo model. A Monte Carlo model uses stock price volatility and other variables to estimate the probability of satisfying the market conditions and the resulting fair value of the award. The compensation cost is not adjusted for changes in estimated probability of achieving the vesting condition. The following table presents the assumptions used in estimating the fair value of the market-condition PSUs, along with their grant-date fair values, during 2014 and 2013.
years ended December 31 |
|
2014 |
|
2013 |
|
Baxter volatility |
|
20% |
|
21% |
|
Peer group volatility |
|
13% - 58% |
|
13% - 38% |
|
Correlation of returns |
|
0.23 - 0.66 |
|
0.37 - 0.62 |
|
Risk-free interest rate |
|
0.7% |
|
0.3% |
|
Fair value per PSU |
|
$57 |
|
$67 |
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 15 SHARE-BASED COMPENSATION (Continued)
A summary of Baxalta PSU activity related to shares held by both Baxalta and Baxter employees for the period following the separation is presented below:
(share units in thousands) |
|
Share
|
|
Weighted-
|
|
|
Nonvested PSUs converted on July 1, 2015 in connection with the separation |
|
551 |
|
$ |
30.17 |
|
Granted |
|
|
|
|
|
|
Vested |
|
(300 |
) |
31.49 |
|
|
Forfeited |
|
(17 |
) |
30.10 |
|
|
Nonvested PSUs at December 31, 2015 |
|
234 |
|
$ |
28.50 |
|
(1) The weighted-average grant date fair value has been adjusted for the impact of the separation
As of December 31, 2015, the unrecognized compensation cost related to all unvested Baxalta or Baxter PSUs held by Baxaltas employees of $2 million is expected to be recognized as expense over a weighted-average period of approximately 1 year.
NOTE 16 LEGAL PROCEEDINGS
The company is involved in product liability, patent, commercial, and other legal matters that arise in the normal course of the companys business. The company records a liability when a loss is considered probable and the amount can be reasonably estimated. If the reasonable estimate of a probable loss is a range, and no amount within the range is a better estimate, the minimum amount in the range is accrued. If a loss is not probable or a probable loss cannot be reasonably estimated, no liability is recorded. As of December 31, 2015, the companys total recorded reserves with respect to legal matters were $23 million and were primarily reported in other long-term liabilities.
Management is not able to estimate the amount or range of any loss for certain contingencies for which there is no reserve or additional loss for matters already reserved. While the liability of the company in connection with the claims cannot be estimated and although the resolution in any reporting period of one or more of these matters could have a significant impact on the companys results of operations and cash flows for that period, the outcome of these legal proceedings is not expected to have a material adverse effect on the companys combined financial position. While the company believes that it has valid defenses in these matters, litigation is inherently uncertain, excessive verdicts do occur, and the company may incur material judgments or enter into material settlements of claims.
The company remains subject to the risk of future administrative and legal actions. With respect to governmental and regulatory matters, these actions may lead to product recalls, injunctions, and other restrictions on the companys operations and monetary sanctions, including significant civil or criminal penalties. With respect to intellectual property, the company may become exposed to significant litigation concerning the scope of the companys and others rights. Such litigation could result in a loss of patent protection or the ability to market products, which could lead to a significant loss of sales, or otherwise materially affect future results of operations.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 17 AGREEMENTS AND TRANSACTIONS WITH BAXTER
Separation-Related Agreements with Baxter
In connection with the separation, the company entered into a manufacturing and supply agreement, transition services agreement and international commercial operations agreement with Baxter.
Under the terms of the manufacturing and supply agreement, Baxalta manufactures certain products and materials and sells them to Baxter at an agreed-upon price reflecting Baxaltas cost plus a mark-up for certain products and materials. As a result, the company began recording revenues associated with the manufacturing and supply agreement during 2015 that were not recorded during periods prior to the separation. Revenues associated with the manufacturing and supply agreement with Baxter were $71 million during 2015. The company also began purchasing products and materials from Baxter at cost plus a mark-up beginning during 2015. The costs associated with the manufacture of these products were included at cost without a mark-up in the companys results of operations in periods prior to the separation. The manufacturing and supply agreement did not contribute a significant amount of gross margin or net income to the companys results of operations during 2015.
Under the terms of the transition services agreement, Baxalta and Baxter provide various services to each other on an interim, transitional basis. The services provided by Baxter to Baxalta include certain finance, information technology, human resources, quality, supply chain and other administrative services and functions, and are generally provided on a cost-plus basis. The services generally extend for approximately 2 years following the separation except for certain information technology services that may extend for 3 years following the separation. During 2015, the company incurred selling, general and administrative expenses of approximately $65 million associated with the transition services agreement with Baxter.
For a certain portion of the companys operations, the legal transfer of Baxaltas net assets did not occur by the separation date of July 1, 2015 due to the time required to transfer marketing authorizations and other regulatory requirements in each of these countries. Under the terms of the international commercial operations agreement with Baxter, the company is responsible for the business activities conducted by Baxter on its behalf, and is subject to the risks and entitled to the benefits generated by these operations and assets. As a result, the related assets and liabilities and results of operations have been reported in the companys consolidated financial statements. Net sales related to these operations totaled approximately $414 million for the last six months of 2015 following the separation. At December 31, 2015, the assets and liabilities consisted of inventories, which are reported in inventories on the consolidated balance sheet, and other assets and liabilities, which are reported in due to or from Baxter International Inc., net, on the consolidated balance sheet. The majority of these operations are expected to be transferred to the company by the end of 2016.
The company and Baxter also entered into a separation and distribution agreement, tax matters agreement, an employee matters agreement and a long-term services agreement in connection with the separation.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 17 AGREEMENTS AND TRANSACTIONS WITH BAXTER (Continued)
The following is a summary of the amounts in the consolidated balance sheet due to or from Baxter, including the assets and liabilities of certain of the companys operations that have not yet transferred to Baxalta and are held by Baxter as of the balance sheet date:
(in millions) |
|
December 31,
|
|
|
Inventories |
|
$ |
101 |
|
Assets to be transferred to Baxalta, held by Baxter |
|
$ |
236 |
|
Other amounts due from Baxter |
|
161 |
|
|
Due from Baxter International Inc. |
|
$ |
397 |
|
Liabilities to be transferred to Baxalta, held by Baxter |
|
$ |
46 |
|
Other amounts due to Baxter |
|
226 |
|
|
Due to Baxter International Inc. |
|
$ |
272 |
|
Other amounts due to or from Baxter primarily relate to intercompany balances which originated prior to the separation and ongoing transactions with Baxter associated with the separation-related agreements described above, including current tax-related indemnification liabilities of $75 million and long-term tax-related indemnification liabilities of $51 million.
Corporate Overhead and Other Allocations from Baxter Prior to Separation
Prior to the separation, the company did not operate as a standalone business and had various relationships with Baxter whereby Baxter provided services to the company. In the financial statements prior to the separation, Baxter provided the company certain services, which included, but were not limited to, executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology and investor relations. The financial information in the combined financial statements in periods prior to the separation did not necessarily include all the expenses that would have been incurred had the company been a separate, standalone entity. Baxter charged the company for these services based on direct and indirect costs. When specific identification was not practicable, a proportional cost method was used, primarily based on sales, headcount, or square footage. These allocations were reflected as follows in financial statements for periods prior to the separation:
(in millions) |
|
6 months
|
|
Year ended
|
|
Year ended
|
|
|||
Cost of sales allocations |
|
$ |
21 |
|
$ |
12 |
|
$ |
37 |
|
Selling, general and administrative allocations |
|
258 |
|
511 |
|
540 |
|
|||
Research and development allocations |
|
5 |
|
14 |
|
15 |
|
|||
Other expense, net allocations |
|
|
|
1 |
|
4 |
|
|||
Total corporate overhead and other allocations from Baxter |
|
$ |
284 |
|
$ |
538 |
|
$ |
596 |
|
Management believes that the methods used to allocate expenses to the companys historical financial statements were reasonable.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 17 AGREEMENTS AND TRANSACTIONS WITH BAXTER (Continued)
Centralized Cash Management Prior to Separation
Prior to the separation, Baxter used a centralized approach to cash management and financing of operations. The majority of the companys subsidiaries were party to Baxters cash pooling arrangements with several financial institutions to maximize the availability of cash for general operating and investing purposes. Under these cash pooling arrangements, cash balances were swept regularly from the companys accounts. Cash transfers to and from Baxters cash concentration accounts and the resulting balances at the end of each reporting period were reflected in net parent company investment in the combined balance sheets. At December 31, 2014, cash and equivalents were not allocated to the company due to Baxters centralized approach to cash management.
NOTE 18 DISCONTINUED OPERATIONS
In July 2014, the company entered into an agreement with Pfizer, Inc. to sell its commercial vaccines business and committed to a plan to divest the remainder of its vaccines business, which included certain R&D programs. In December 2014, the company completed the divestiture of the commercial vaccines business and recorded an after-tax gain of $417 million. During 2015, the company recorded a net after-tax gain of $3 million as a result of purchase price adjustments.
In December 2014, the company entered into a separate agreement with Nanotherapeutics, Inc. for the sale of certain vaccines-related R&D programs. The company completed the divestiture in August 2015 and received cash proceeds of approximately $34 million and recorded an after-tax gain of $28 million.
As a result of the divestitures, the operations and cash flows of the vaccines business have been eliminated from the ongoing operations of the company.
Following is a summary of the operating results of the vaccines business, which have been reflected as discontinued operations for the years ended December 31, 2015, 2014 and 2013:
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Net sales |
|
$ |
1 |
|
$ |
301 |
|
$ |
292 |
|
(Loss) income from discontinued operations before income taxes, excluding gain on sale |
|
(4 |
) |
150 |
|
3 |
|
|||
Gain on sale before income taxes |
|
38 |
|
466 |
|
|
|
|||
Income tax expense |
|
(6 |
) |
(65 |
) |
(3 |
) |
|||
|
|
|
|
|
|
|
|
|||
Income from discontinued operations, net of taxes |
|
$ |
28 |
|
$ |
551 |
|
$ |
|
|
NOTE 19 GEOGRAPHIC AND PRODUCT INFORMATION
Net sales are based on product shipment destination and assets are based on physical location.
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Net sales |
|
|
|
|
|
|
|
|||
United States |
|
$ |
3,315 |
|
$ |
3,016 |
|
$ |
2,861 |
|
Rest of world |
|
2,833 |
|
2,936 |
|
2,694 |
|
|||
|
|
|
|
|
|
|
|
|||
Consolidated and combined net sales |
|
$ |
6,148 |
|
$ |
5,952 |
|
$ |
5,555 |
|
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 19 GEOGRAPHIC AND PRODUCT INFORMATION (Continued)
as of December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
PP&E, net |
|
|
|
|
|
|
|
|||
United States |
|
$ |
3,173 |
|
$ |
2,411 |
|
$ |
1,472 |
|
Austria |
|
780 |
|
717 |
|
812 |
|
|||
Switzerland |
|
359 |
|
353 |
|
382 |
|
|||
Singapore |
|
354 |
|
333 |
|
308 |
|
|||
Rest of world |
|
368 |
|
378 |
|
402 |
|
|||
|
|
|
|
|
|
|
|
|||
Consolidated and combined PP&E, net |
|
$ |
5,034 |
|
$ |
4,192 |
|
$ |
3,376 |
|
Significant Product Sales
The following is a summary of net sales for the Companys five product categories.
years ended December 31 (in millions) |
|
2015 |
|
2014 |
|
2013 |
|
|||
Hemophilia(1) |
|
$ |
2,840 |
|
$ |
2,984 |
|
$ |
2,786 |
|
Immunoglobulin Therapies(2) |
|
1,750 |
|
1,677 |
|
1,616 |
|
|||
Inhibitor Therapies(3) |
|
787 |
|
744 |
|
651 |
|
|||
BioTherapeutics(4) |
|
684 |
|
547 |
|
502 |
|
|||
Oncology(5) |
|
87 |
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Consolidated and combined net sales |
|
$ |
6,148 |
|
$ |
5,952 |
|
$ |
5,555 |
|
(1) Primarily includes sales of recombinant factor VIII and factor IX products (ADVATE, ADYNOVATE, RECOMBINATE, and RIXUBIS) and plasma-derived hemophilia products (primarily factor VII, factor VIII and factor IX).
(2) Includes sales of antibody-replacement immunoglobulin therapy products, including GAMMAGARD LIQUID, SUBCUVIA and HYQVIA.
(3) Includes sales of FEIBA, a plasma-derived hemophilia product to treat patients who have developed inhibitors and OBIZUR, a recombinant porcine factor VIII product for the treatment of acquired hemophilia A.
(4) Includes primarily plasma-derived specialty therapies including albumin and alpha-1 antitrypsin products, as well as contract manufacturing revenue.
(5) Includes sales of ONCASPAR, a treatment for acute lymphoblastic leukemia.
Concentration of Credit Risk
The company engages in business with foreign governments in certain countries that have experienced deterioration in credit and economic conditions, including Greece, Spain, Portugal, Italy and Brazil. As of December 31, 2015, the companys net accounts receivable from the public sector in Greece, Spain, Portugal and Italy totaled $80 million, of which Greece receivables represented an immaterial balance. The company also has significant accounts receivable related to its Hemobrás partnership in Brazil totaling $207 million at December 31, 2015.
Global economic conditions and liquidity issues in certain countries have resulted, and may continue to result, in delays in the collection of receivables and credit losses. While the company believes that its allowance for doubtful accounts as of December 31, 2015 is adequate, future governmental actions and customer-specific factors may require the company to re-evaluate the collectability of its receivables and the company could potentially incur additional credit losses that materially impact its results of operations.
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 20 QUARTERLY FINANCIAL RESULTS (UNAUDITED)
(in millions, except per share data) |
|
First
|
|
Second
|
|
Third
|
|
Fourth
|
|
Full year |
|
|||||
2015 |
|
|
|
|
|
|
|
|
|
|
|
|||||
Net sales |
|
$ |
1,361 |
|
$ |
1,429 |
|
$ |
1,595 |
|
$ |
1,763 |
|
$ |
6,148 |
|
Gross margin |
|
790 |
|
928 |
|
962 |
|
1,082 |
|
3,762 |
|
|||||
Income from continuing operations(1) |
|
262 |
|
284 |
|
281 |
|
101 |
|
928 |
|
|||||
Income (loss) from continuing operations per common share(1) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic |
|
0.39 |
|
0.42 |
|
0.42 |
|
0.15 |
|
1.37 |
|
|||||
Diluted |
|
0.38 |
|
0.42 |
|
0.41 |
|
0.15 |
|
1.36 |
|
|||||
Income (loss) from discontinued operations, net of tax(1) |
|
10 |
|
(4 |
) |
28 |
|
(6 |
) |
28 |
|
|||||
Income (loss) from discontinued operations per common share(1) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic |
|
0.02 |
|
(0.01 |
) |
0.04 |
|
(0.01 |
) |
0.04 |
|
|||||
Diluted |
|
0.02 |
|
(0.01 |
) |
0.04 |
|
(0.01 |
) |
0.04 |
|
|||||
Net income(1) |
|
272 |
|
280 |
|
309 |
|
95 |
|
956 |
|
|||||
Net income per common share(1) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic |
|
0.41 |
|
0.41 |
|
0.46 |
|
0.14 |
|
1.41 |
|
|||||
Diluted |
|
0.40 |
|
0.41 |
|
0.45 |
|
0.14 |
|
1.40 |
|
|||||
Cash dividends declared per common share |
|
0.00 |
|
0.00 |
|
0.07 |
|
0.07 |
|
0.14 |
|
|||||
2014 |
|
|
|
|
|
|
|
|
|
|
|
|||||
Net sales |
|
$ |
1,329 |
|
$ |
1,452 |
|
$ |
1,488 |
|
$ |
1,683 |
|
$ |
5,952 |
|
Gross margin |
|
770 |
|
853 |
|
874 |
|
1,012 |
|
3,509 |
|
|||||
Income from continuing operations(2) |
|
309 |
|
318 |
|
225 |
|
334 |
|
1,186 |
|
|||||
Income from continuing operations per common share(2) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic |
|
0.46 |
|
0.47 |
|
0.33 |
|
0.49 |
|
1.75 |
|
|||||
Diluted |
|
0.45 |
|
0.47 |
|
0.33 |
|
0.49 |
|
1.74 |
|
|||||
Income from discontinued operations, net of tax(2) |
|
49 |
|
52 |
|
21 |
|
429 |
|
551 |
|
|||||
Income from discontinued operations per common share(2) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic |
|
0.07 |
|
0.08 |
|
0.03 |
|
0.64 |
|
0.82 |
|
|||||
Diluted |
|
0.07 |
|
0.08 |
|
0.03 |
|
0.63 |
|
0.81 |
|
|||||
Net income(2) |
|
358 |
|
370 |
|
246 |
|
763 |
|
1,737 |
|
|||||
Net income per common share(2) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic |
|
0.53 |
|
0.55 |
|
0.36 |
|
1.13 |
|
2.57 |
|
|||||
Diluted |
|
0.52 |
|
0.55 |
|
0.36 |
|
1.12 |
|
2.55 |
|
|||||
Cash dividends declared per common share |
|
0.00 |
|
0.00 |
|
0.00 |
|
0.00 |
|
0.00 |
|
(1) The first quarter of 2015 included net after-tax charges from continuing operations of $33 million related to intangible asset amortization, business optimization items, and separation costs; and a $9 million after-tax favorable adjustment to the gain recorded on sale of the companys commercial vaccines business reported in discontinued operations. The second quarter of 2015 included net after-tax charges from continuing operations of $109 million related to intangible asset amortization, business optimization items, separation costs, and milestone payments associated with the companys collaboration agreements; and a $4 million after-tax charge reported in discontinued
BAXALTA INCORPORATED
NOTES TO CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS (Continued)
NOTE 20 QUARTERLY FINANCIAL RESULTS (UNAUDITED) (Continued)
operations. The third quarter of 2015 included net after-tax charges from continuing operations of $104 million related to intangible asset amortization, separation costs, IPR&D and other impairment charges, a decrease in the fair value of contingent payment liabilities, milestone payments associated with the companys collaboration agreements and business development items; and a $28 million after-tax gain recorded on the sale of certain vaccines R&D programs reported in discontinued operations. The fourth quarter of 2015 included net after-tax charges from continuing operations of $286 million related to intangible asset amortization, business optimization items, separation costs, upfront and milestone payments to collaboration partners, a decrease in the fair value of contingent payment liabilities, a currency-related item and favorable adjustments to previously recorded impairment charges; and a $6 million after-tax unfavorable adjustment to the gain recorded on sale of the companys commercial vaccines business reported in discontinued operations.
(2) The first quarter of 2014 included net after-tax charges from continuing operations of $24 million related to intangible asset amortization, business optimization items, plasma-related litigation and milestone payments associated with the companys collaboration agreements; and an $8 million after-tax charge reported in discontinued operations. The second quarter of 2014 included net after-tax charges from continuing operations of $63 million related to intangible asset amortization, business optimization items, separation costs, milestone payments associated with the companys collaboration agreements and an increase in fair value of contingent payment liabilities. The third quarter of 2014 included net after-tax charges from continuing operations of $166 million related to intangible asset amortization, business optimization items, separation costs, the Branded Prescription Drug Fee and milestone payments associated with the companys collaboration arrangements; and after-tax charges of $5 million after-tax charge reported in discontinued operations. The fourth quarter of 2014 included net after-tax charges from continuing operations of $146 million related to intangible asset amortization, business optimization items, separation costs, milestone payments associated with the companys collaboration agreements, other-than-temporary impairment and an increase in fair value of contingent payment liabilities; and a $417 million after-tax gain on the sale of the companys commercial vaccines business reported in discontinued operations.
Exhibit 99.3
INDEX TO FINANCIAL STATEMENTS
For the quarterly period ended March 31, 2016
AUDITED COMBINED FINANCIAL STATEMENTS: |
|
Condensed Consolidated and Combined Balance Sheets |
2 |
Condensed Consolidated and Combined Statements of Income |
3 |
Condensed Consolidated and Combined Statements of Comprehensive Income |
4 |
Condensed Consolidated and Combined Statements of Cash Flows |
5 |
Condensed Consolidated and Combined Statements of Changes in Equity |
6 |
Notes to Condensed Consolidated and Combined Financial Statements |
7 |
BAXALTA INCORPORATED
CONDENSED CONSOLIDATED AND COMBINED BALANCE SHEETS
(UNAUDITED)
(in millions, except share data) |
|
March 31,
|
|
December 31,
|
|
||
Assets |
|
|
|
|
|
||
Current Assets: |
|
|
|
|
|
||
Cash and equivalents |
|
$ |
911 |
|
$ |
1,001 |
|
Accounts and other current receivables, net |
|
1,127 |
|
914 |
|
||
Inventories |
|
2,237 |
|
2,173 |
|
||
Prepaid expenses and other current assets |
|
601 |
|
620 |
|
||
Total current assets |
|
4,876 |
|
4,708 |
|
||
Property, plant and equipment, net |
|
5,208 |
|
5,034 |
|
||
Goodwill |
|
883 |
|
829 |
|
||
Other intangible assets, net |
|
1,320 |
|
1,295 |
|
||
Other long-term assets |
|
537 |
|
463 |
|
||
Total assets |
|
$ |
12,824 |
|
$ |
12,329 |
|
Liabilities and Equity |
|
|
|
|
|
||
Current Liabilities: |
|
|
|
|
|
||
Current maturities of capital lease obligations |
|
$ |
5 |
|
$ |
3 |
|
Short-term debt |
|
302 |
|
|
|
||
Accounts payable |
|
427 |
|
706 |
|
||
Accrued liabilities |
|
1,244 |
|
1,202 |
|
||
Total current liabilities |
|
1,978 |
|
1,911 |
|
||
Long-term debt and capital lease obligations |
|
5,317 |
|
5,265 |
|
||
Other long-term liabilities |
|
1,309 |
|
1,229 |
|
||
Commitments and contingencies |
|
|
|
|
|
||
Equity: |
|
|
|
|
|
||
Common stock, $0.01 par value (shares authorized of 2,500,000,000 at March 31, 2016 and December 31, 2015, shares issued and outstanding of 682,775,012 at March 31, 2016 and 679,287,500 at December 31, 2015) |
|
7 |
|
7 |
|
||
Additional paid-in capital |
|
4,167 |
|
4,103 |
|
||
Retained earnings |
|
404 |
|
309 |
|
||
Accumulated other comprehensive loss |
|
(358 |
) |
(495 |
) |
||
Total equity |
|
4,220 |
|
3,924 |
|
||
Total liabilities and equity |
|
$ |
12,824 |
|
$ |
12,329 |
|
The accompanying notes are an integral part of these condensed consolidated and combined financial statements.
BAXALTA INCORPORATED
CONDENSED CONSOLIDATED AND COMBINED STATEMENTS OF INCOME
(UNAUDITED)
|
|
Three months ended
|
|
||||
(in millions, except per share amounts) |
|
2016 |
|
2015 |
|
||
Net sales |
|
$ |
1,548 |
|
$ |
1,361 |
|
Cost of sales |
|
710 |
|
571 |
|
||
Gross margin |
|
838 |
|
790 |
|
||
Selling, general and administrative expenses |
|
384 |
|
283 |
|
||
Research and development expenses |
|
280 |
|
156 |
|
||
Net interest expense |
|
23 |
|
|
|
||
Other (income) expense, net |
|
(21 |
) |
12 |
|
||
Income from continuing operations before income taxes |
|
172 |
|
339 |
|
||
Income tax expense |
|
27 |
|
77 |
|
||
Net income from continuing operations |
|
145 |
|
262 |
|
||
Income from discontinued operations, net of tax |
|
|
|
10 |
|
||
Net income |
|
$ |
145 |
|
$ |
272 |
|
|
|
|
|
|
|
||
|
|
|
|
|
|
||
Income from continuing operations per common share |
|
|
|
|
|
||
Basic |
|
$ |
0.21 |
|
$ |
0.39 |
|
Diluted |
|
$ |
0.21 |
|
$ |
0.38 |
|
|
|
|
|
|
|
||
Income from discontinued operations per common share |
|
|
|
|
|
||
Basic |
|
$ |
|
|
$ |
0.02 |
|
Diluted |
|
$ |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
||
Net income per common share |
|
|
|
|
|
||
Basic |
|
$ |
0.21 |
|
$ |
0.41 |
|
Diluted |
|
$ |
0.21 |
|
$ |
0.40 |
|
|
|
|
|
|
|
||
Weighted-average number of common shares outstanding |
|
|
|
|
|
||
Basic |
|
681 |
|
676 |
|
||
Diluted |
|
690 |
|
681 |
|
||
|
|
|
|
|
|
||
Cash dividends declared per common share |
|
$ |
0.07 |
|
$ |
|
|
The accompanying notes are an integral part of these condensed consolidated and combined financial statements.
BAXALTA INCORPORATED
CONDENSED CONSOLIDATED AND COMBINED STATEMENTS OF COMPREHENSIVE INCOME
(UNAUDITED)
|
|
Three months ended
|
|
||||
(in millions) |
|
2016 |
|
2015 |
|
||
Net income |
|
$ |
145 |
|
$ |
272 |
|
Other comprehensive income (loss), net of tax: |
|
|
|
|
|
||
Currency translation adjustments, net of tax (expense) benefit of ($6) and $3 for the three months ended March 31, 2016 and 2015, respectively |
|
169 |
|
(353 |
) |
||
Pension and other employee benefits, net of tax benefit (expense) of $5 and ($3) for the three months ended March 31, 2016 and 2015, respectively |
|
7 |
|
8 |
|
||
Available-for-sale securities, net of tax benefit (expense) of $8 and ($4) for the three months ended March 31, 2016 and 2015, respectively |
|
(27 |
) |
5 |
|
||
Hedging activities, net of tax benefit of $6 and $20 for the three months ended March 31, 2016 and 2015, respectively |
|
(12 |
) |
(35 |
) |
||
Total other comprehensive income (loss), net of tax |
|
137 |
|
(375 |
) |
||
Comprehensive income (loss) |
|
$ |
282 |
|
$ |
(103 |
) |
The accompanying notes are an integral part of these condensed consolidated and combined financial statements.
BAXALTA INCORPORATED
CONDENSED CONSOLIDATED AND COMBINED STATEMENTS OF CASH FLOWS
(UNAUDITED)
|
|
Three months ended,
|
|
||||
(in millions) |
|
2016 |
|
2015 |
|
||
Cash flows from operations |
|
|
|
|
|
||
Net income |
|
$ |
145 |
|
$ |
272 |
|
Adjustments |
|
|
|
|
|
||
Depreciation and amortization |
|
76 |
|
58 |
|
||
Share-based compensation expense |
|
21 |
|
10 |
|
||
Excess tax benefits from share-based compensation |
|
(5 |
) |
(2 |
) |
||
Net periodic pension benefit and OPEB cost |
|
17 |
|
15 |
|
||
Business optimization charges (benefits) |
|
66 |
|
(10 |
) |
||
Other |
|
(37 |
) |
(1 |
) |
||
Changes in balance sheet items |
|
|
|
|
|
||
Accounts and other current receivables, net |
|
(69 |
) |
(27 |
) |
||
Inventories |
|
(24 |
) |
(91 |
) |
||
Accounts payable |
|
(75 |
) |
(37 |
) |
||
Due to/from Baxter International Inc. |
|
49 |
|
|
|
||
Accrued liabilities |
|
(20 |
) |
(295 |
) |
||
Business optimization payments |
|
(8 |
) |
(4 |
) |
||
Other |
|
(8 |
) |
(30 |
) |
||
Net cash provided from (used for) operations |
|
128 |
|
(142 |
) |
||
Cash flows from investing activities |
|
|
|
|
|
||
Capital expenditures |
|
(235 |
) |
(301 |
) |
||
Acquisitions, net of cash acquired |
|
(280 |
) |
(228 |
) |
||
Other investing activities |
|
(33 |
) |
(18 |
) |
||
Net cash used for investing activities |
|
(548 |
) |
(547 |
) |
||
Cash flows from financing activities |
|
|
|
|
|
||
Cash dividends on common stock |
|
(48 |
) |
|
|
||
Net transactions with Baxter International Inc. |
|
11 |
|
689 |
|
||
Increase in debt with maturities of three months or less, net |
|
300 |
|
|
|
||
Proceeds and excess tax benefits related to share-based compensation |
|
74 |
|
|
|
||
Other financing activities |
|
(9 |
) |
|
|
||
Net cash provided from financing activities |
|
328 |
|
689 |
|
||
Effect of foreign exchange rate changes on cash and equivalents |
|
2 |
|
|
|
||
Change in cash and equivalents |
|
(90 |
) |
|
|
||
Cash and equivalents at beginning of period |
|
1,001 |
|
|
|
||
Cash and equivalents at end of period |
|
$ |
911 |
|
$ |
|
|
The accompanying notes are an integral part of these condensed consolidated and combined financial statements.
BAXALTA INCORPORATED
CONDENSED CONSOLIDATED AND COMBINED STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
|
|
Common Stock |
|
Additional
|
|
Net Parent
|
|
Retained |
|
|
|
Total |
|
||||||||
(in millions, except share data) |
|
Shares |
|
Amount |
|
Capital |
|
Investment |
|
Earnings |
|
AOCI |
|
Equity |
|
||||||
Balance as of December 31, 2014 |
|
|
|
$ |
|
|
$ |
|
|
$ |
6,180 |
|
$ |
|
|
$ |
(433 |
) |
$ |
5,747 |
|
Net income |
|
|
|
|
|
|
|
272 |
|
|
|
|
|
272 |
|
||||||
Net transfers to Baxter International Inc. |
|
|
|
|
|
|
|
720 |
|
|
|
|
|
720 |
|
||||||
Other comprehensive loss, net of tax |
|
|
|
|
|
|
|
|
|
|
|
(375 |
) |
(375 |
) |
||||||
Balance as of March 31, 2015 |
|
|
|
$ |
|
|
$ |
|
|
$ |
7,172 |
|
$ |
|
|
$ |
(808 |
) |
$ |
6,364 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Balance as of December 31, 2015 |
|
679,287,500 |
|
$ |
7 |
|
4,103 |
|
$ |
|
|
$ |
309 |
|
$ |
(495 |
) |
$ |
3,924 |
|
|
Net income |
|
|
|
|
|
|
|
|
|
145 |
|
|
|
145 |
|
||||||
Separation-related adjustments |
|
|
|
|
|
(16 |
) |
|
|
|
|
|
|
(16 |
) |
||||||
Share-based compensation expense |
|
|
|
|
|
22 |
|
|
|
|
|
|
|
22 |
|
||||||
Shares issued under employee benefit plans and other |
|
3,487,512 |
|
|
|
58 |
|
|
|
(2 |
) |
|
|
56 |
|
||||||
Other comprehensive income, net of tax |
|
|
|
|
|
|
|
|
|
|
|
137 |
|
137 |
|
||||||
Dividends declared ($0.07 per share) |
|
|
|
|
|
|
|
|
|
(48 |
) |
|
|
(48 |
) |
||||||
Balance as of March 31, 2016 |
|
682,775,012 |
|
$ |
7 |
|
$ |
4,167 |
|
$ |
|
|
$ |
404 |
|
$ |
(358 |
) |
$ |
4,220 |
|
The accompanying notes are an integral part of these condensed consolidated and combined financial statements.
BAXALTA INCORPORATED
NOTES TO CONDENSED CONSOLIDATED AND COMBINED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1 NATURE OF BUSINESS AND BASIS OF PREPARATION
Baxalta Incorporated, together with its subsidiaries, (Baxalta or the company) is a global innovative biopharmaceutical leader with a sustainable portfolio of differentiated therapies that seek to address unmet medical needs across many disease areas, including hematology, immunology and oncology.
Separation from Baxter
Baxalta was incorporated in Delaware on September 8, 2014. The company separated from Baxter International Inc. (Baxter or Parent) on July 1, 2015 (the separation), becoming an independent company as a result of a pro rata distribution by Baxter of 80.5% of Baxaltas common stock to Baxters shareholders. Baxter retained an approximate 19.5% ownership stake in Baxalta immediately following the distribution. Baxalta common stock began trading regular way under the ticker symbol BXLT on the New York Stock Exchange on July 1, 2015.
In January 2016 and March 2016, Baxter exchanged portions of its retained stake in Baxalta common stock for indebtedness of Baxter held by third parties. The shares of Baxalta common stock exchanged were then sold by such third parties in secondary public offerings pursuant to registration statements filed by Baxalta. Following these transactions, Baxter held approximately 4.5% of Baxaltas total shares outstanding.
In April 2016, Baxter commenced an offer to exchange up to 13.4 million shares of Baxalta common stock that are currently owned by Baxter, which represents approximately 2.0% of the outstanding common stock of Baxalta, for shares of Baxter common stock that are validly tendered and not validly withdrawn in the exchange offer. Prior to or following the completion of that exchange offer, Baxter has informed Baxalta that Baxter intends to make a contribution to Baxters U.S. pension fund or distribute as a special dividend to all Baxter stockholders, on a pro rata basis, some or all of its remaining shares of Baxalta common stock. Following the completion of these transactions, if Baxter disposes of all of the remaining shares of Baxalta common stock held by it, Baxalta will be wholly independent from Baxter, except that certain agreements between Baxter and Baxalta will remain in place.
Merger Agreement with Shire plc
In January 2016, the company announced that it had reached an agreement (merger agreement) with Shire plc (Shire) under which Shire would acquire Baxalta, forming a global leader in rare diseases. Under the terms of the agreement, Baxalta shareholders will receive $18.00 in cash and 0.1482 Shire American Depository Shares (ADS) per each Baxalta share. The transaction has been approved by the boards of directors of both Shire and Baxalta. Closing of the transaction is subject to approval by Baxalta and Shire shareholders, certain regulatory approvals, receipt of certain tax opinions and other customary closing conditions. The Baxalta and Shire shareholder votes are scheduled for May 27, 2016. The transaction is expected to close in early June 2016.
The merger agreement provides for certain termination rights for both Shire and Baxalta. Upon termination of the merger agreement under certain specified circumstances, Baxalta may be required to disburse to Shire a termination fee of $369 million and Shire may be required to pay the company a termination fee of $369 million. In addition, if the merger agreement is terminated under certain specified circumstances following the receipt of an acquisition proposal by Baxalta, Baxalta may be required to reimburse Shire for transaction expenses up to $110 million (which expenses would be credited against any termination fee subsequently disbursed by Baxalta). Conversely, if the merger agreement is terminated under certain specified circumstances following the receipt of an acquisition proposal by Shire, Shire may be required to reimburse Baxalta for transaction expenses up to $65 million (which expenses would be credited against any termination fee subsequently payable by Shire).
Basis of Preparation
The unaudited interim condensed consolidated and combined financial statements of the company for all periods presented have been prepared pursuant to the rules and regulations of the SEC. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States (GAAP) have been condensed or omitted. The year-end condensed consolidated balance sheet data was derived from the audited consolidated financial statements, but does not include all disclosures required by GAAP. These unaudited interim condensed consolidated and combined financial statements should be read in conjunction with the financial statements and notes contained in the companys 2015 Annual Report on Form 10-K, as filed with the SEC on March 3, 2016 (2015 Annual Report).
In the opinion of management, the unaudited interim condensed consolidated and combined financial statements reflect all adjustments necessary for a fair statement of the interim periods. All such adjustments, unless otherwise noted herein, are of a normal, recurring nature. The results of operations for the interim period are not necessarily indicative of the results of operations to be expected for the full year.
As further described above, Baxalta became an independent publicly traded company following the separation from Baxter on July 1, 2015. The accompanying unaudited interim condensed consolidated and combined financial statements reflect the consolidated financial position and results of operations of the company as an independent, publicly-traded company for periods after the July 1, 2015 separation. The consolidated and combined financial statements reflect the combined results of operations of the company as a combined reporting entity of Baxter for periods prior to the separation.
Prior to the separation, the companys financial statements were prepared on a standalone basis and were derived from Baxters consolidated financial statements and accounting records as if the former biopharmaceuticals business of Baxter had been part of Baxalta. The combined financial statements reflected the companys financial position, results of operations and cash flows as the business was operated as part of Baxter prior to the separation, in conformity with GAAP.
Prior to the separation, all transactions between the company and Baxter were considered to be effectively settled in the combined financial statements at the time the transaction was recorded. The total net effect of the settlement of the transactions with Baxter were reflected in the statements of cash flows in periods prior to the separation as a financing activity and in the statement of shareholders equity as net parent company investment.
Prior to the separation, the combined financial statements included an allocation of expenses related to certain Baxter corporate functions, including senior management, legal, human resources, finance, treasury, information technology, and quality assurance. These expenses were allocated to the company based on direct usage or benefit where specifically identifiable, with the remainder allocated primarily on a pro rata basis of revenue, headcount, square footage, or other measures. The company considers the expense methodology and results to be reasonable for all periods prior to the separation. However, the allocations may not be indicative of the actual expense that would have been incurred had the company operated as an independent, publicly traded company for the periods prior to the separation.
Prior to the separation, the companys equity balance represented the excess of total assets over total liabilities, including the due to/from balances between the company and Baxter (net parent company investment) and accumulated other comprehensive income (AOCI). Net parent company investment was primarily impacted by distributions and contributions to or from Baxter, which were the result of treasury activities and net funding provided by or distributed to Baxter. In connection with the separation, the companys net parent company investment balance was reclassified to additional paid-in capital.
New Accounting Standards
In March 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-09, Improvements to Employer Share-Based Compensation Accounting, which includes provisions intended to simplify various aspects related to how share-based payments are accounted for and presented in the financial statements. Key provisions of ASU 2016-09 include a requirement to record tax effects of share-based payments at settlement (or expiration) through the statement of income, which is to be adopted on a prospective basis, and to report tax-related cash flows resulting from share-based payments as operating activities on the statement of cash flows, which can be adopted on a prospective or retrospective basis. ASU 2016-09 will be effective for the company beginning on January 1, 2017. Early adoption is permitted. The company is currently evaluating the impact of adopting this standard on its consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which requires lessees to recognize right-of-use assets and lease liabilities on the balance sheet. ASU 2016-02 is to be applied using a modified retrospective approach at the beginning of the earliest comparative period in the financial statements. ASU 2016-02 will be effective for the company beginning on January 1, 2019. Early adoption is permitted. The company is currently evaluating the impact of adopting this standard on its consolidated financial statements.
In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments Overall (Subtopic 825-10) Recognition and Measurement of Financial Assets and Financial Liabilities. ASU 2016-01 requires that equity investments, except those accounted for under the equity method of accounting or those that result in consolidation of the investee, be measured at fair value, with subsequent changes in fair value recognized in net income. In addition, the ASU requires a qualitative assessment of equity investments without readily determinable fair values when assessing impairment, the evaluation of a valuation allowance on a deferred tax asset related to available-for-sale securities and certain presentation and disclosures for financial instruments. ASU 2016-01 is applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption, which will be January 1, 2018. Early adoption is not permitted. The company is currently evaluating the impact of adopting this standard on its consolidated financial statements.
In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory, which clarifies that inventory should be measured at the lower of cost or net realizable value. ASU 2015-11 defines net realizable value as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The company adopted ASU No. 2015-11 beginning on January 1, 2016 on a prospective basis. The impact of this adoption was not material.
In April 2015, the FASB issued ASU No. 2015-05, Intangibles Goodwill and Other Internal-Use Software (Subtopic 350-40): Customers Accounting for Fees Paid in a Cloud Computing Arrangement, which provides guidance to customers about how to account for cloud computing arrangements when such arrangements include software licenses. The company adopted ASU No. 2015-05 beginning on January 1, 2016 on a prospective basis. The impact of this adoption was not material.
In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), which amends the existing accounting standards for revenue recognition. ASU 2014-09 is based on principles that govern the recognition of revenue at an amount an entity expects to be entitled to when products are transferred to customers. In July 2015, the FASB voted to approve a one-year deferral on the original effective date of January 1, 2017; therefore ASU No. 2014-09 will be effective for the company beginning on January 1, 2018. Early adoption is permitted as of the original effective date. The new revenue standard may be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the date of adoption. The company is currently evaluating the impact of adopting the new revenue standard on its consolidated financial statements.
NOTE 2 SUPPLEMENTAL FINANCIAL INFORMATION
Net Interest Expense
The company issued senior notes with an aggregate principal amount of $5 billion in June 2015. Prior to the issuance of the senior notes, Baxalta recorded no interest expense because Baxters third-party debt and the related interest expense were not allocated to the company.
|
|
Three months ended
|
|
||||
(in millions) |
|
2016 |
|
2015 |
|
||
Interest costs |
|
$ |
47 |
|
$ |
|
|
Interest costs capitalized |
|
(23 |
) |
|
|
||
Interest expense, net of capitalized interest |
|
24 |
|
|
|
||
Interest income |
|
(1 |
) |
|
|
||
Net interest expense |
|
$ |
23 |
|
$ |
|
|
Inventories
(in millions) |
|
March 31,
|
|
December 31,
|
|
||
Raw materials |
|
$ |
589 |
|
$ |
589 |
|
Work in process |
|
1,029 |
|
1,021 |
|
||
Finished goods |
|
619 |
|
563 |
|
||
Total inventories |
|
$ |
2,237 |
|
$ |
2,173 |
|
Prepaid Expenses and Other Current Assets
(in millions) |
|
March 31,
|
|
December 31,
|
|
||
Due from Baxter |
|
$ |
387 |
|
$ |
397 |
|
Prepaid expenses and other |
|
214 |
|
223 |
|
||
Prepaid expenses and other current assets |
|
$ |
601 |
|
$ |
620 |
|
Accrued Liabilities
(in millions) |
|
March 31,
|
|
December 31,
|
|
||
Due to Baxter |
|
$ |
341 |
|
$ |
208 |
|
Accrued rebates |
|
242 |
|
245 |
|
||
Employee compensation and withholdings |
|
200 |
|
286 |
|
||
Property, payroll and certain other taxes |
|
97 |
|
97 |
|
||
Income taxes payable |
|
26 |
|
77 |
|
||
Other |
|
338 |
|
289 |
|
||
Total accrued liabilities |
|
$ |
1,244 |
|
$ |
1,202 |
|
Other Long-Term Liabilities
(in millions) |
|
March 31,
|
|
December 31,
|
|
||
Pension and other employee benefits |
|
$ |
524 |
|
$ |
505 |
|
Contingent payment liabilities |
|
448 |
|
426 |
|
||
Long-term deferred income taxes |
|
176 |
|
181 |
|
||
Due to Baxter |
|
102 |
|
64 |
|
||
Other |
|
59 |
|
53 |
|
||
Total other long-term liabilities |
|
$ |
1,309 |
|
$ |
1,229 |
|
Concentration of Credit Risk
Baxalta engages in business with foreign governments in certain countries that have experienced deterioration in credit and economic conditions, including Greece, Spain, Portugal, Italy and Brazil. As of March 31, 2016, the companys net accounts receivable from the public sector in Greece, Spain, Portugal and Italy totaled $95 million, of which Greece receivables represented a $27 million balance. The company also has significant accounts receivable related to its Hemobrás partnership in Brazil totaling $174 million at March 31, 2016.
Global economic conditions and liquidity issues in certain countries have resulted, and may continue to result, in delays in the collection of receivables and credit losses. While the company believes that its allowance for doubtful accounts as of March 31, 2016 is adequate, future governmental actions and customer-specific factors may require the company to re-evaluate the collectability of its receivables and the company could potentially incur additional credit losses that materially impact its results of operations.
NOTE 3 EARNINGS PER SHARE
The denominator for basic earnings per common share (EPS) is the weighted-average number of common shares outstanding during the period. The dilutive effect of outstanding stock options, restricted stock units (RSUs) and performance share units (PSUs) is reflected in the denominator for diluted EPS using the treasury stock method. The numerator for both basic and diluted EPS is net income, net income from continuing operations, or income from discontinued operations, net of tax.
On July 1, 2015, Baxter distributed approximately 544 million shares of Baxalta common stock to its shareholders and retained an additional 132 million shares. The computation of basic EPS for the three months ended March 31, 2015 was calculated using the shares distributed and retained by Baxter on July 1, 2015 totaling 676 million. The weighted average number of shares outstanding for diluted EPS for the three months ended March 31, 2015 included 5 million of diluted common share equivalents for stock options, RSUs and PSUs as calculated using the treasury stock method as of July 1, 2015, as these share-based awards were previously issued by Baxter and outstanding at the time of separation and were assumed by Baxalta following the separation.
The following is a reconciliation of basic shares to diluted shares.
|
|
Three months ended
|
|
||
(in millions) |
|
2016 |
|
2015 |
|
Basic shares |
|
681 |
|
676 |
|
Effect of dilutive shares |
|
9 |
|
5 |
|
Diluted shares |
|
690 |
|
681 |
|
The computation of diluted EPS excluded 3 million and 19 million weighted-average equity awards outstanding for the three months ended March 31, 2016 and 2015 as their inclusion would have an anti-dilutive effect on diluted EPS.
NOTE 4 ACQUISITIONS AND COLLABORATIONS
Acquisitions
SuppreMol Acquisition
In March 2015, the company acquired all of the outstanding shares of SuppreMol GmbH (SuppreMol), a privately held biopharmaceutical company based in Germany, for cash of $228 million, net of cash acquired. Through the acquisition, the company obtained SuppreMols early-stage pipeline of treatment options for autoimmune and allergic diseases, as well as its operations in Munich, Germany. The acquired investigational treatments complement and build upon the companys immunology portfolio and offer an opportunity to expand into new areas with significant market potential and unmet medical needs in autoimmune diseases. The acquired net assets comprised a business based on the acquired inputs, processes and outputs. As a result, the transaction was accounted for as a business combination.
ONCASPAR Business Acquisition
In July 2015, the company acquired the ONCASPAR (pegaspargase) product portfolio from Sigma-Tau Finanziaria S.p.A (Sigma-Tau), a privately held biopharmaceutical company based in Italy, through the acquisition of 100% of the shares of a subsidiary of Sigma-Tau, for cash of $890 million, net of cash acquired. Through the acquisition, the company gained the marketed biologic treatment ONCASPAR, the investigational biologic calaspargase pegol, and an established oncology infrastructure with clinical and sales resources. ONCASPAR is a first-line biologic used as part of a chemotherapy regimen to treat patients with acute lymphoblastic leukemia. As of the acquisition date, it was marketed in the United States, Germany, Poland and certain other countries, and recently received EU approval. The acquired net assets comprised a business based on the acquired inputs, processes and outputs. As a result, the transaction was accounted for as a business combination. ONCASPAR sales recorded by the company during the 3 months ended March 31, 2016 were $52 million.
Collaborations
Precision BioSciences
In February 2016, Baxalta entered into a strategic immuno-oncology collaboration with Precision BioSciences (Precision), a private biopharmaceutical company based in the United States, specializing in genome editing technology. Together, Baxalta and Precision will develop chimeric antigen receptor (CAR) T cell therapies for up to six unique targets, with the first program expected to enter clinical studies in late 2017. On a product-by-product basis, following successful completion of early-stage research activities up to Phase 2, Baxalta will have exclusive option rights to complete late-stage development and worldwide commercialization. Precision is responsible for development costs for each target prior to option exercise.
The company made an upfront payment of $105 million to Precision, which was recorded as R&D expense during the three months ended March 31, 2016. The company may make additional payments related to option fees and development, regulatory, and commercial milestones totaling up to $1.6 billion, in addition to future royalty payments on worldwide sales. Precision also has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States.
Research and Development Costs Funded by Collaboration Partners
The company recorded offsets to R&D expense of $24 million for development costs funded by collaboration partners during the three months ended March 31, 2016.
Unfunded Contingent Payments
At March 31, 2016, the companys unfunded contingent milestone payments associated with all of its collaborative arrangements totaled $1.8 billion. This total includes contingent payments associated with R&D costs funded by collaboration partners through March 31, 2016. This total excludes contingent royalty and profit-sharing payments, contingent payment liabilities arising from business combinations, potential milestone payments and option exercise fees associated with certain of the companys collaboration agreements that become payable only if the company chooses to exercise one or more of its options and potential contingent payments associated with R&D costs that may be funded by collaboration partners in the future. Based on the companys projections, any contingent payments made in the future will be more than offset by the estimated net future cash flows relating to the rights acquired for those payments.
NOTE 5 GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill
The following is a summary of the activity in goodwill:
(in millions) |
|
|
|
|
December 31, 2015 |
|
$ |
829 |
|
Additions |
|
37 |
|
|
Currency translation and other adjustments |
|
17 |
|
|
March 31, 2016 |
|
$ |
883 |
|
As of March 31, 2016, there were no accumulated goodwill impairment losses.
Other intangible assets, net
The following is a summary of the companys other intangible assets:
(in millions) |
|
Developed
|
|
Other
|
|
Indefinite-lived
|
|
Total |
|
||||
March 31, 2016 |
|
|
|
|
|
|
|
|
|
||||
Gross other intangible assets |
|
$ |
1,287 |
|
$ |
30 |
|
$ |
246 |
|
$ |
1,563 |
|
Accumulated amortization |
|
(213 |
) |
(30 |
) |
|
|
(243 |
) |
||||
Other intangible assets, net |
|
$ |
1,074 |
|
$ |
|
|
$ |
246 |
|
$ |
1,320 |
|
|
|
|
|
|
|
|
|
|
|
||||
December 31, 2015 |
|
|
|
|
|
|
|
|
|
||||
Gross other intangible assets |
|
$ |
1,247 |
|
$ |
29 |
|
$ |
238 |
|
$ |
1,514 |
|
Accumulated amortization |
|
(190 |
) |
(29 |
) |
|
|
(219 |
) |
||||
Other intangible assets, net |
|
$ |
1,057 |
|
$ |
|
|
$ |
238 |
|
$ |
1,295 |
|
The increase in other intangible assets, net during the three months ended March 31, 2016 was due to foreign currency exchange rate fluctuations, partially offset by amortization expense.
Intangible asset amortization expense was $19 million and $8 million during the three months ended March 31, 2016 and 2015, respectively. The following table presents anticipated annual amortization expense for 2016 through 2020 for definite-lived intangible assets recorded as of March 31, 2016:
years ending (in millions) |
|
2016 |
|
2017 |
|
2018 |
|
2019 |
|
2020 |
|
|||||
Anticipated annual intangible asset amortization expense |
|
$ |
78 |
|
$ |
75 |
|
$ |
75 |
|
$ |
71 |
|
$ |
71 |
|
NOTE 6 BUSINESS OPTIMIZATION ITEMS
The companys total charges (benefits) related to business optimization plans are presented below:
|
|
Three months
|
|
||||
(in millions) |
|
2016 |
|
2015 |
|
||
Charges |
|
$ |
66 |
|
$ |
|
|
Reserve adjustments |
|
|
|
(10 |
) |
||
Total business optimization expenses (benefits) |
|
$ |
66 |
|
$ |
(10 |
) |
During the three months ended March 31, 2016, the company approved a business optimization plan to optimize its overall cost structure on a global basis by streamlining certain operations and rationalizing certain manufacturing facilities. The company recorded a charge of $66 million in cost of sales during the three months ended March 31, 2016 associated with this plan. The charge consisted of fixed assets and inventory impairments of $36 million and estimated severance and other costs of $30 million.
Prior to the separation, the company participated in business optimization plans initiated by Baxter. During the three months ended March 31, 2015, the company adjusted its previously estimated business optimization charges due to changes in assumptions resulting in a $10 million benefit recorded during the period. The adjustments were primarily due to lower severance payments than previously estimated from business optimization programs in prior years.
The following table summarizes activity in the reserves during the three months ended March 31, 2016 related to business optimization initiatives:
(in millions) |
|
|
|
|
Reserves as of December 31, 2015 |
|
$ |
12 |
|
Charges |
|
30 |
|
|
Utilization |
|
(8 |
) |
|
Currency translation adjustments and other |
|
(1 |
) |
|
Reserves as of March 31, 2016 |
|
$ |
33 |
|
The reserves are expected to be substantially utilized by the end of 2016. Management believes that these reserves are adequate. However, adjustments may be recorded in the future as the programs are completed.
NOTE 7 DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITY
The company does not hold any instruments for trading purposes and none of the companys outstanding derivative instruments contain credit-risk-related contingent features.
Interest Rate Risk Management
The company is exposed to the risk that its earnings and cash flows could be adversely impacted by fluctuations in benchmark interest rates relating to its existing debt obligations or anticipated issuances of debt. The companys policy is to manage this risk to an acceptable level.
Foreign Currency Risk Management
The company is primarily exposed to foreign exchange risk with respect to recognized assets and liabilities, forecasted transactions and net assets denominated in the Euro, Japanese Yen, British Pound, Swiss Franc, Australian Dollar, Turkish Lira, Russian Ruble, Chinese Renminbi, Colombian Peso and Argentine Peso. The companys policy is to manage this risk to an acceptable level.
In periods prior to the separation, the company participated in Baxters foreign currency risk management program through a central shared entity, which entered into derivative contracts to hedge foreign currency risk associated with forecasted transactions for the entire company, including for Baxaltas operations. Gains and losses on derivative contracts entered into by Baxter were allocated to Baxalta and partially offset gains and losses on underlying foreign currency exposures. The fair values of outstanding derivative instruments were not allocated to Baxaltas balance sheets. In connection with the separation, the company began entering into foreign currency derivative contracts on its own behalf and has recorded the related fair value on its condensed consolidated balance sheets as of March 31, 2016 and December 31, 2015. The contracts are classified as either short-term or long-term based on the scheduled maturity of the instrument.
Cash Flow Hedges
The company may use options, including collars and purchased options, and forwards to hedge the foreign exchange risk to earnings relating to forecasted transactions and recognized assets and liabilities. The company may use forward-starting interest rate swaps and treasury rate locks to hedge the risk to earnings associated with movements in interest rates relating to anticipated issuances of debt.
For each derivative instrument that is designated and effective as a cash flow hedge, the gain or loss on the derivative is recorded in AOCI and then recognized in earnings consistent with the underlying hedged item. Option premiums or net premiums paid are initially recorded as assets and reclassified to other comprehensive income (OCI) over the life of the option, and then recognized in earnings consistent with the underlying hedged item. Cash flow hedges are classified in net sales, cost of sales, and net interest expense, and primarily relate to forecasted third-party sales denominated in foreign currencies, forecasted intercompany sales denominated in foreign currencies, and anticipated issuances of debt, respectively.
The maximum term over which the company has cash flow hedge contracts in place related to forecasted transactions as of March 31, 2016 was 12 months. The notional amount of foreign exchange contracts totaled $1.1 billion as of March 31, 2016 and $1.2 billion as of December 31, 2015. There were no interest rate contracts designated as cash flow hedges outstanding at March 31, 2016 or December 31, 2015.
In certain instances, the company may discontinue cash flow hedge accounting because the forecasted transactions are no longer probable of occurring. As of March 31, 2016, all forecasted transactions were probable of occurring and no gains or losses were reclassified into earnings.
Fair Value Hedges
The company uses interest rate swaps to convert a portion of its fixed-rate debt into variable-rate debt. These instruments hedge the companys earnings from changes in the fair value of debt due to fluctuations in the designated benchmark interest rate. For each derivative instrument that is designated and effective as a fair value hedge, the gain or loss on the derivative is recognized immediately to earnings, and offsets the respective loss or gain on the underlying hedged item. Fair value hedges are classified in net interest expense, as they hedge the interest rate risk associated with certain of the companys fixed-rate debt.
The notional amount of interest rate swaps totaled $1.0 billion at both March 31, 2016 and December 31, 2015.
Undesignated Derivative Instruments
The company uses forward contracts to hedge earnings from the effects of foreign exchange relating to certain of the companys intercompany and third-party receivables and payables denominated in a foreign currency. These derivative instruments generally are not formally designated as hedges, the terms of these instruments generally do not exceed one month and the change in fair value of these derivatives are reported in earnings.
The notional amount of undesignated derivative instruments totaled $142 million as of March 31, 2016 and $209 million as of December 31, 2015.
Gains and Losses on Derivative Instruments
The following tables summarize the income statement locations and gains and losses on the companys derivative instruments for the three months ended March 31, 2016 and 2015.
|
|
Gain (loss) recognized in
|
|
Income
|
|
Gain (loss) reclassified from
|
|
||||||||
(in millions) |
|
2016 |
|
2015 |
|
location |
|
2016 |
|
2015 |
|
||||
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
||||
Interest rate contracts |
|
$ |
|
|
$ |
(55 |
) |
Net interest expense |
|
$ |
|
|
$ |
|
|
Foreign exchange contracts |
|
(1 |
) |
|
|
Net sales |
|
|
|
|
|
||||
Foreign exchange contracts |
|
(11 |
) |
|
|
Cost of sales |
|
6 |
|
|
|
||||
Total |
|
$ |
(12 |
) |
$ |
(55 |
) |
|
|
$ |
6 |
|
$ |
|
|
|
|
Income
|
|
Gain (loss) recognized in income |
|
||||
(in millions) |
|
location |
|
2016 |
|
2015 |
|
||
Fair value hedges |
|
|
|
|
|
|
|
||
Interest rate contracts |
|
Net interest expense |
|
$ |
36 |
|
$ |
|
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
Other (income) expense, net |
|
$ |
4 |
|
$ |
|
|
For the companys fair value hedges, a loss of $36 million was recognized in net interest expense during the three month period ending March 31, 2016, as adjustments to the underlying hedged item, fixed-rate debt. Ineffectiveness related to the companys cash flow and fair value hedges for the three months ended March 31, 2016 and March 31, 2015 was not material.
As of March 31, 2016, $1 million of deferred, net after-tax gains on derivative instruments included in AOCI are expected to be recognized in earnings during the next 12 months, coinciding with when the hedged items are expected to impact earnings. Refer to Note 10 for the balance in AOCI associated with cash flow hedges.
Fair Values of Derivative Instruments
The following table presents the classification and estimated fair value of the companys derivative instruments as of March 31, 2016:
|
|
Derivatives in asset positions |
|
Derivatives in liability positions |
|
||||||
(in millions) |
|
Balance sheet
|
|
Fair
|
|
Balance sheet
|
|
Fair value |
|
||
Derivative instruments designated as hedges |
|
|
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
Prepaid expenses and other current assets |
|
$ |
14 |
|
Accrued liabilities |
|
$ |
7 |
|
Interest rate contracts |
|
Other long-term assets |
|
41 |
|
|
|
|
|
||
Total derivative instruments designated as hedges |
|
|
|
$ |
55 |
|
|
|
$ |
7 |
|
|
|
|
|
|
|
|
|
|
|
||
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
Prepaid expenses and other current assets |
|
$ |
|
|
Accrued liabilities |
|
$ |
|
|
Total derivative instruments |
|
|
|
$ |
55 |
|
|
|
$ |
7 |
|
The following table presents the classification and estimated fair value of the companys derivative instruments as of December 31, 2015:
|
|
Derivatives in asset positions |
|
Derivatives in liability positions |
|
||||||
(in millions) |
|
Balance sheet
|
|
Fair
|
|
Balance sheet
|
|
Fair value |
|
||
Derivative instruments designated as hedges |
|
|
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
Prepaid expenses and other current assets |
|
$ |
23 |
|
Accrued liabilities |
|
$ |
2 |
|
Foreign exchange contracts |
|
Other long-term assets |
|
|
|
Other long-term liabilities |
|
|
|
||
Interest rate contracts |
|
Other long-term assets |
|
4 |
|
|
|
|
|
||
Total derivative instruments designated as hedges |
|
|
|
$ |
27 |
|
|
|
$ |
2 |
|
|
|
|
|
|
|
|
|
|
|
||
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
Prepaid expenses and other current assets |
|
$ |
1 |
|
Accrued liabilities |
|
$ |
1 |
|
Total derivative instruments |
|
|
|
$ |
28 |
|
|
|
$ |
3 |
|
|
|
|
|
|
|
|
|
|
|
While the companys derivatives are all subject to master netting arrangements, the company presents its assets and liabilities related to derivative instruments on a gross basis within the condensed consolidated balance sheets. Additionally, the company is not required to post collateral for any of its outstanding derivatives. If the companys derivatives were presented on a net basis, assets of $48 million and $25 million would be reported at March 31, 2016 and December 31, 2015, respectively.
NOTE 8 DEBT, FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Credit Facilities and Commercial Paper
As of March 31, 2016 and December 31, 2015, there were no outstanding borrowings under the companys primary and Euro-denominated revolving credit facilities. The companys maximum capacity of the facilities is reduced for the issuance of letters of credit. As of March 31, 2016 and December 31, 2015, the amount of letters of credit issued was immaterial.
During the three months ended March 31, 2016, the company issued and redeemed commercial paper, of which $300 million was outstanding as of March 31, 2016, with a weighted-average interest rate of 1.12%. This commercial paper is classified as short-term debt on the condensed consolidated balance sheet. The company did not have any commercial paper outstanding as of December 31, 2015.
Securitization arrangement
In April 2015, the company entered into agreements related to its trade receivables originating in Japan with a financial institution in which the entire interest in and ownership of the receivables are sold. While the company services the receivables in its Japanese securitization arrangement, no servicing asset or liability is recognized because the company receives adequate compensation to service the sold receivables.
During the three months ended March 31, 2016, sold receivables were $48 million and cash collections remitted to the owners of the receivables were $61 million. The effect of currency exchange rate changes and net losses relating to the sales of receivables were immaterial.
Fair Value Measurements
The following tables summarize the bases under the fair value hierarchy used to measure financial assets and liabilities that are carried at fair value on a recurring basis in the consolidated balance sheets:
|
|
|
|
Basis of fair value measurement |
|
||||||||
(in millions) |
|
Balance as
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
|
||||
Assets |
|
|
|
|
|
|
|
|
|
||||
Foreign currency derivative contracts |
|
$ |
14 |
|
$ |
|
|
$ |
14 |
|
$ |
|
|
Interest rate contracts |
|
41 |
|
|
|
41 |
|
|
|
||||
Available-for-sale securities |
|
|
|
|
|
|
|
|
|
||||
Equity securities |
|
45 |
|
45 |
|
|
|
|
|
||||
Foreign government debt securities |
|
16 |
|
3 |
|
13 |
|
|
|
||||
Total assets |
|
$ |
116 |
|
$ |
48 |
|
$ |
68 |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liabilities |
|
|
|
|
|
|
|
|
|
||||
Contingent payments |
|
$ |
458 |
|
$ |
|
|
$ |
|
|
$ |
458 |
|
Foreign currency derivative contracts |
|
7 |
|
|
|
7 |
|
|
|
||||
Total liabilities |
|
$ |
465 |
|
$ |
|
|
$ |
7 |
|
$ |
458 |
|
|
|
|
|
Basis of fair value measurement |
|
||||||||
(in millions) |
|
Balance as
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
|
||||
Assets |
|
|
|
|
|
|
|
|
|
||||
Foreign currency derivative contracts |
|
$ |
24 |
|
$ |
|
|
$ |
24 |
|
$ |
|
|
Interest rate contracts |
|
4 |
|
|
|
4 |
|
|
|
||||
Available-for-sale securities |
|
|
|
|
|
|
|
|
|
||||
Equity securities |
|
78 |
|
78 |
|
|
|
$ |
|
|
|||
Foreign government debt securities |
|
16 |
|
3 |
|
13 |
|
|
|
||||
Total assets |
|
$ |
122 |
|
$ |
81 |
|
$ |
41 |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liabilities |
|
|
|
|
|
|
|
|
|
||||
Contingent payments |
|
$ |
433 |
|
$ |
|
|
$ |
|
|
$ |
433 |
|
Foreign currency derivative contracts |
|
3 |
|
|
|
3 |
|
|
|
||||
Total liabilities |
|
$ |
436 |
|
$ |
|
|
$ |
3 |
|
$ |
433 |
|
For assets that are measured using quoted prices in active markets, the fair value is the published market price per unit multiplied by the number of units held, without consideration of transaction costs. The fair values of foreign government debt securities are obtained from pricing services or broker/dealers who either use quoted prices in an active market or proprietary pricing applications, which include observable market information for like or same securities. Primarily all of the derivatives entered into by the company are valued using internal valuation techniques as no quoted prices exist for such instruments. The principal techniques used to value these instruments are discounted cash flow and Black-Scholes models. The key inputs used to value these instruments are observable and vary depending on the type of derivative, and include contractual terms, interest rate yield curves and foreign exchange rates.
The following table is a reconciliation of the fair value measurements that use significant unobservable inputs (Level 3), which consists of contingent payment liabilities:
(in millions) |
|
Contingent
|
|
|
Fair value as of December 31, 2015 |
|
$ |
433 |
|
Additions |
|
23 |
|
|
Payments |
|
|
|
|
Net gains recognized in earnings |
|
(1 |
) |
|
Currency translation adjustments |
|
3 |
|
|
Fair value as of March 31, 2016 |
|
$ |
458 |
|
The addition during the three months ended March 31, 2016 relates to the formation of a joint venture in Turkey that is consolidated. The company has an option to acquire the remaining 50% of the Turkey joint venture from the non-controlling owners and the non-controlling owners have a put option to sell their 50% ownership to the company in 2021 and every 5 years thereafter. The fair value of the option to acquire the 50% interest was $23 million as of March 31, 2016 and was calculated using a discounted cash flow technique.
Contingent payments related to acquisitions consist of development, regulatory and commercial milestone payments, in addition to sales-based payments, and are valued using discounted cash flow techniques. The fair value of development, regulatory and commercial milestone payments reflects managements expectations of probability of payment, and increases or decreases as the probability of payment or expectation of timing of payments changes. Managements expected weighted-average probability of payment for development, regulatory and commercial milestone payments was approximately 21% as of both March 31, 2016 and December 31, 2015, with individual probabilities ranging from 10%-80%. The weighted average discount rate used in the fair value estimates was 8.1% as of both March 31, 2016 and December 31, 2015. The fair value of sales-based payments is based upon probability-weighted future revenue estimates, and increases or decreases as revenue estimates or expectations of timing of payments change.
Available for Sale Securities
The following table provides information relating to the companys investments in available-for-sale equity securities:
(in millions) |
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
|
||||
March 31, 2016 Available-for-sale equity securities |
|
$ |
55 |
|
$ |
10 |
|
$ |
(20 |
) |
$ |
45 |
|
December 31, 2015 Available-for-sale equity securities |
|
$ |
55 |
|
$ |
28 |
|
$ |
(5 |
) |
$ |
78 |
|
The company recorded $9 million in other-than-temporary impairment charges in other (income) expense, net during the three months ended March 31, 2015 based on the duration of losses related to two of the companys investments. There were no other-than-temporary impairment charges recorded during the three months ended March 31, 2016 as the company believes the unrealized losses to be temporary in nature.
Book Values and Fair Values of Financial Instruments
In addition to the financial instruments that the company is required to recognize at fair value on the condensed consolidated balance sheets, the company has certain financial instruments that are recognized at historical cost or some basis other than fair value. For these financial instruments, the following table provides the values recognized on the condensed consolidated balance sheets and the approximate fair values:
|
|
Book values |
|
Approximate fair values |
|
||||||||
(in millions) |
|
March 31,
|
|
December 31,
|
|
March 31,
|
|
December 31,
|
|
||||
Assets |
|
|
|
|
|
|
|
|
|
||||
Investments |
|
$ |
24 |
|
$ |
21 |
|
$ |
24 |
|
$ |
21 |
|
|
|
|
|
|
|
|
|
|
|
||||
Liabilities |
|
|
|
|
|
|
|
|
|
||||
Short-term debt |
|
302 |
|
|
|
302 |
|
|
|
||||
Current maturities of capital lease obligations |
|
5 |
|
3 |
|
5 |
|
3 |
|
||||
Long-term debt and capital lease obligations |
|
$ |
5,317 |
|
$ |
5,265 |
|
$ |
5,639 |
|
$ |
5,396 |
|
Investments include certain cost method investments whose fair value is based on Level 3 inputs. The estimated fair value of capital lease obligations is based on Level 2 inputs. The estimated fair values of long-term debt were computed by multiplying price by the notional amount of the respective debt instrument. Price is calculated using the stated terms of the respective debt instrument and yield curves commensurate with the companys credit risk. The discount factors used in the calculations reflect the non-performance risk of the company. The carrying values of the other financial instruments approximate their fair values due to the short-term maturities of most of these assets and liabilities.
Limited Partnership Commitment
The company had unfunded commitments of $75 million and $79 million as a limited partner in various equity investments as of March 31, 2016 and December 31, 2015, respectively.
NOTE 9 RETIREMENT AND OTHER BENEFIT PROGRAMS
Shared Baxter Plans Prior to the Separation
During the second quarter of 2015, Baxalta assumed certain pension and other post-employment benefit (OPEB) obligations and plan assets related to newly-created single employer plans for Baxalta employees, as well as pension obligations and plan assets associated with its employees who participated in certain plans that split following the separation.
Prior to the assumption of these net pension and OPEB plan obligations, and with the exception of certain Austrian defined benefit pension plans of which Baxalta was previously the sole sponsor, the companys employees participated in certain U.S. and international defined benefit pension and OPEB plans sponsored by Baxter. These plans included participants of Baxters other businesses and were accounted for as multiemployer plans in the companys financial statements prior to the transfer into newly-created plans sponsored by Baxalta. The costs of these plans were allocated to the company and recorded in cost of sales, selling, general and administrative expenses and R&D expenses in the condensed combined statement of income for the three months ended March 31, 2015. For the Baxter sponsored defined benefit pension and OPEB plans, Baxalta recorded expense of $12 million during the three months ended March 31, 2015.
The company has been the sole sponsor for certain Austrian defined benefit plans prior to the separation and has accounted for the Austrian defined benefit plans as single employer plans for both periods presented below.
Net Periodic Benefit Cost
Net periodic benefit cost associated with Baxaltas single employer pension and OPEB plans consisted of the following for the three months ended March 31, 2016 and 2015:
|
|
U.S. Pension and OPEB |
|
International Pension |
|
||||||||
|
|
Three months ended
|
|
Three months ended
|
|
||||||||
(in millions) |
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
||||
Net periodic benefit cost |
|
|
|
|
|
|
|
|
|
||||
Service costs |
|
$ |
5 |
|
$ |
|
|
$ |
7 |
|
$ |
1 |
|
Interest costs |
|
5 |
|
|
|
2 |
|
1 |
|
||||
Expected return on plan assets |
|
(4 |
) |
|
|
(2 |
) |
|
|
||||
Amortization of net losses and other deferred amounts |
|
1 |
|
|
|
3 |
|
1 |
|
||||
Total net periodic benefit cost |
|
$ |
7 |
|
$ |
|
|
$ |
10 |
|
$ |
3 |
|
The U.S. OPEB plan is not presented separately because the net periodic benefit cost associated with the plan was not significant for the periods presented.
NOTE 10 ACCUMULATED OTHER COMPREHENSIVE INCOME
The following is a net-of-tax summary of the changes in AOCI by component for the three months ended March 31, 2016 and 2015.
(in millions) |
|
Foreign
|
|
Pension
|
|
Available-
|
|
Hedging
|
|
Total |
|
|||||
Gains (losses) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance as of December 31, 2015 |
|
$ |
(359 |
) |
$ |
(186 |
) |
$ |
17 |
|
$ |
33 |
|
$ |
(495 |
) |
Other comprehensive income (loss) before reclassifications |
|
169 |
|
4 |
|
(27 |
) |
(8 |
) |
138 |
|
|||||
Amounts reclassified from AOCI (a) |
|
|
|
3 |
|
|
|
(4 |
) |
(1 |
) |
|||||
Net other comprehensive income (loss) |
|
169 |
|
7 |
|
(27 |
) |
(12 |
) |
137 |
|
|||||
Balance as of March 31, 2016 |
|
$ |
(190 |
) |
$ |
(179 |
) |
$ |
(10 |
) |
$ |
21 |
|
$ |
(358 |
) |
(in millions) |
|
Foreign
|
|
Pension
|
|
Available-
|
|
Hedging
|
|
Total |
|
|||||
Gains (losses) |
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance as of December 31, 2014 |
|
$ |
(387 |
) |
$ |
(52 |
) |
$ |
7 |
|
$ |
(1 |
) |
$ |
(433 |
) |
Other comprehensive (loss) income before reclassifications |
|
(353 |
) |
7 |
|
(2 |
) |
(35 |
) |
(383 |
) |
|||||
Amounts reclassified from AOCI (a) |
|
|
|
1 |
|
7 |
|
|
|
8 |
|
|||||
Net other comprehensive (loss) income |
|
(353 |
) |
8 |
|
5 |
|
(35 |
) |
(375 |
) |
|||||
Balance as of March 31, 2015 |
|
$ |
(740 |
) |
$ |
(44 |
) |
$ |
12 |
|
$ |
(36 |
) |
$ |
(808 |
) |
(a) See table below for details about these reclassifications.
The following is a summary of the amounts reclassified from AOCI to net income during the three months ended March 31, 2016 and 2015.
|
|
Amounts reclassified from AOCI (a) |
|
||||||
|
|
Three months ended
|
|
Income
|
|
||||
(in millions) |
|
2016 |
|
2015 |
|
Location |
|
||
Amortization of pension and other employee benefits |
|
|
|
|
|
|
|
||
Actuarial losses and other |
|
$ |
(4 |
) |
$ |
(1 |
) |
|
(b) |
|
|
(4 |
) |
(1 |
) |
Total before tax |
|
||
|
|
1 |
|
|
|
Tax benefit |
|
||
|
|
$ |
(3 |
) |
$ |
(1 |
) |
Net of tax |
|
|
|
|
|
|
|
|
|
||
Gains on hedging activities |
|
|
|
|
|
|
|
||
Foreign exchange contracts |
|
$ |
6 |
|
$ |
|
|
Cost of sales |
|
|
|
6 |
|
|
|
Total before tax |
|
||
|
|
(2 |
) |
|
|
Tax expense |
|
||
|
|
$ |
4 |
|
$ |
|
|
Net of tax |
|
|
|
|
|
|
|
|
|
||
Losses on available-for-sale securities |
|
|
|
|
|
|
|
||
Other-than-temporary impairment of available-for-sale equity security |
|
$ |
|
|
$ |
(9 |
) |
Other (income) expense, net |
|
|
|
|
|
(9 |
) |
Total before tax |
|
||
|
|
|
|
2 |
|
Tax benefit |
|
||
|
|
|
|
(7 |
) |
Net of tax |
|
||
|
|
|
|
|
|
|
|
||
Total reclassification for the period |
|
$ |
1 |
|
$ |
(8 |
) |
Total net of tax |
|
(a) Amounts in parentheses indicate reductions to net income.
(b) These AOCI components are included in the computation of net periodic benefit cost disclosed in Note 9.
NOTE 11 INCOME TAXES
Effective Tax Rate
The companys effective income tax rate from continuing operations was 15.7% and 22.7% during the three months ended March 31, 2016 and 2015, respectively. The companys effective income tax rate differs from the U.S. federal statutory rate each year due to state and local taxes, certain operations that are subject to tax incentives and foreign taxes that are different from the U.S. federal statutory rate. In addition, the effective tax rate can be affected each period by discrete factors and events.
The effective income tax rate during the three months ended March 31, 2016 was favorably impacted by an increase in the amount of expenditures qualifying for the U.S. Research & Experimentation tax credit and the settlement of an indemnification liability with Baxter. The effective income tax rate during the three month ended March 31, 2015 was favorably impacted by separation-related costs incurred during the period that were deductible at tax rates higher that the effective tax rate.
NOTE 12 SHARE-BASED COMPENSATION
Impact of Separation from Baxter
Prior to the separation, Baxalta employees participated in Baxters incentive stock program and Baxalta recorded expenses in cost of sales, selling, general and administrative expenses and R&D expenses for its employees participation in the program. In connection with the separation, outstanding Baxter equity awards granted prior to January 1, 2015 and held by Baxter or Baxalta employees were adjusted into both Baxter and Baxalta equity awards. Awards granted after January 1, 2015 and certain awards granted during 2014 were adjusted entirely
into corresponding awards of either Baxter or Baxalta, based on which company would employ the holder following the separation. The value of the combined Baxter and Baxalta stock-based awards after the separation was designed to generally preserve the intrinsic value and the fair value of the award immediately prior to separation. In periods following the separation, Baxalta records share-based compensation costs relating to its employees Baxalta and Baxter equity awards.
Share-Based Compensation Expense
The table below presents share-based compensation expense by statement of income line item.
|
|
Three months ended
|
|
||||
(in millions) |
|
2016 |
|
2015 |
|
||
Cost of sales |
|
$ |
2 |
|
$ |
2 |
|
Selling, general and administrative expense |
|
16 |
|
6 |
|
||
Research and development expenses |
|
3 |
|
2 |
|
||
Total share-based compensation expense |
|
$ |
21 |
|
$ |
10 |
|
Stock Options
The company did not grant stock options during the three months ended March 31, 2016. The weighted-average Black-Scholes assumptions used in estimating the fair value of stock options granted during the three months ended March 31, 2015 by Baxter prior to the separation, along with the weighted-average grant-date fair values, were as follows:
|
|
Three months
|
|
|
Expected volatility |
|
20 |
% |
|
Expected life (in years) |
|
5.5 |
|
|
Risk-free interest rate |
|
1.7 |
% |
|
Dividend yield |
|
3.0 |
% |
|
Fair value per stock option |
|
$ |
9.2 |
|
The total intrinsic value of Baxalta stock options exercised by both Baxter and Baxalta employees was $40 million during the three months ended March 31, 2016.
As of March 31, 2016, the unrecognized compensation cost related to all unvested Baxalta and Baxter stock options held by Baxaltas employees totaled $52 million, and is expected to be recognized as expense over a weighted-average period of 2.1 years.
RSUs
During the three months ended March 31, 2016, the company awarded approximately 2.6 million RSUs, which were primarily part of its annual equity grant to employees.
As of March 31, 2016, the unrecognized compensation cost related to all unvested Baxalta and Baxter RSUs held by Baxaltas employees totaled $132 million, and is expected to be recognized as expense over a weighted-average period of 2.4 years.
PSUs
The company did not grant PSUs during the three months ended March 31, 2016. As of March 31, 2016, the unrecognized compensation cost related to all unvested Baxalta and Baxter PSUs held by Baxaltas employees totaled $2 million, and is expected to be recognized as expense over a weighted-average period of less than one year.
NOTE 13 LEGAL PROCEEDINGS
The company is involved in product liability, patent, commercial, and other legal matters that arise in the normal course of the companys business. The company records a liability when a loss is considered probable and the amount can be reasonably estimated. If the reasonable estimate of a probable loss is a range, and no amount within the range is a better estimate, the minimum amount in the range is accrued. If a loss is not probable or a probable loss cannot be reasonably estimated, no liability is recorded. As of March 31, 2016, the companys total recorded reserves with respect to legal matters were $23 million and were primarily reported in other long-term liabilities.
Management is not able to estimate the amount or range of any loss for certain contingencies for which there is no reserve or additional loss for matters already reserved. While the liability of the company in connection with the claims cannot be estimated and although the resolution in any reporting period of one or more of these matters could have a significant impact on the companys results of operations and cash flows for that period, the outcome of these legal proceedings is not expected to have a material adverse effect on the companys consolidated financial position. While the company believes that it has valid defenses in these matters, litigation is inherently uncertain, excessive verdicts do occur, and the company may incur material judgments or enter into material settlements of claims.
The company remains subject to the risk of future administrative and legal actions. With respect to governmental and regulatory matters, these actions may lead to product recalls, injunctions, and other restrictions on the companys operations and monetary sanctions, including significant civil or criminal penalties. With respect to intellectual property, the company may become exposed to significant litigation
concerning the scope of the companys and others rights. Such litigation could result in a loss of patent protection or the ability to market products, which could lead to a significant loss of sales, or otherwise materially affect future results of operations.
NOTE 14 AGREEMENTS AND TRANSACTIONS WITH BAXTER
Separation-Related Agreements with Baxter
In connection with the separation, the company entered into a manufacturing and supply agreement, transition services agreement and international commercial operations agreement with Baxter.
Under the terms of the manufacturing and supply agreement, Baxalta manufactures certain products and materials and sells them to Baxter at an agreed-upon price reflecting Baxaltas cost plus a mark-up for certain products and materials. As a result, the company has recorded revenues associated with the manufacturing and supply agreement during the three months ended March 31, 2016 that were not recorded during the three months ended March 31, 2015. Revenues associated with the manufacturing and supply agreement with Baxter were $41 million during the three months ended March 31, 2016. The manufacturing and supply agreement did not contribute a significant amount of gross margin or net income to the companys results of operations during the three months ended March 31, 2016.
Under the terms of the transition services agreement, Baxalta and Baxter provide various services to each other on an interim, transitional basis. The services provided by Baxter to Baxalta include certain finance, information technology, human resources, quality, supply chain and other administrative services and functions, and are generally provided on a cost-plus basis. The services generally extend for approximately 2 years following the separation except for certain information technology services that may extend for 3 years following the separation. During the three months ended March 31, 2016, the company incurred selling, general and administrative expenses of approximately $30 million associated with the transition services agreement with Baxter.
For a certain portion of the companys operations, the legal transfer of Baxaltas net assets did not occur by the separation date of July 1, 2015 due to the time required to transfer marketing authorizations and other regulatory requirements in certain countries. Under the terms of the international commercial operations agreement with Baxter, the company is responsible for the business activities conducted by Baxter on its behalf, and is subject to the risks and entitled to the benefits generated by these operations and assets. As a result, the related assets and liabilities and results of operations have been reported in the companys condensed consolidated and combined financial statements.
In February 2016, the transfer of certain of these operations to Baxalta was completed. A majority of the remaining operations held by Baxter as of March 31, 2016 are expected to be transferred by the end of 2016.
Net sales related to operations not transferred to Baxalta and held by Baxter totaled approximately $121 million for the three months ended March 31, 2016. At March 31, 2016 and December 31, 2015, the assets and liabilities consisted of inventories, which are reported in inventories on the condensed consolidated balance sheets, as well as other assets and liabilities, which are reported in due to or from Baxter within the condensed consolidated balance sheets.
The company and Baxter also entered into a separation and distribution agreement, tax matters agreement, an employee matters agreement and a long-term services agreement in connection with the separation.
The following is a summary of the amounts in the condensed consolidated balance sheets due to or from Baxter, including the assets and liabilities of certain of the companys operations that have not yet transferred to Baxalta and are held by Baxter as of the balance sheet date:
(in millions) |
|
March
|
|
December
|
|
||
|
|
|
|
|
|
||
Inventories |
|
$ |
29 |
|
$ |
101 |
|
|
|
|
|
|
|
||
Assets to be transferred to Baxalta, held by Baxter |
|
$ |
97 |
|
$ |
236 |
|
Other amounts due from Baxter |
|
324 |
|
161 |
|
||
Due from Baxter |
|
$ |
421 |
|
$ |
397 |
|
|
|
|
|
|
|
||
Liabilities to be transferred to Baxalta, held by Baxter |
|
$ |
10 |
|
$ |
46 |
|
Other amounts due to Baxter |
|
433 |
|
226 |
|
||
Due to Baxter |
|
$ |
443 |
|
$ |
272 |
|
The decreases in inventories and assets and liabilities to be transferred to Baxalta, held by Baxter were primarily due to completion of the legal transfer of certain operations during the three months ended March 31, 2016.
Other amounts due to or from Baxter primarily relate to intercompany balances which originated prior to the separation and ongoing transactions with Baxter associated with the separation-related agreements described above, including current tax-related indemnification liabilities of $4 million and $75 million as of March 31, 2016 and December 31, 2015, respectively, and long-term tax-related indemnification liabilities of $69 million and $51 million as of March 31, 2016 and December 31, 2015, respectively. Certain indemnification liabilities classified as short-term as of December 31, 2015 were settled during the three months ended March 31, 2016 or were reclassified to long-term as of March 31, 2016 due to changes in the estimated date of resolution. The company recorded a gain in other (income) expense, net of $20 million during the three months ended March 31, 2016 following the settlement of an indemnification liability with Baxter.
Corporate Overhead and Other Allocations from Baxter Prior to Separation
During the three months ended March 31, 2015, the company did not operate as a standalone business and had various relationships with Baxter whereby Baxter provided services to the company. In the financial statements prior to the separation, Baxter provided the company certain services, which included, but were not limited to, executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology and investor relations. The financial information in the combined financial statements for the three months ended March 31, 2015 did not necessarily include all the expenses that would have been incurred had the company been a separate, standalone entity. Baxter charged the company for these services based on direct and indirect costs. When specific identification was not practicable, a proportional cost method was used, primarily based on sales, headcount, or square footage. These allocations were reflected as follows during the three months ended March 31, 2015:
(in millions) |
|
Three months
|
|
|
Cost of sales allocations |
|
$ |
9 |
|
Selling, general and administrative allocations |
|
122 |
|
|
Research and development allocations |
|
1 |
|
|
Total corporate overhead and other allocations from Baxter |
|
$ |
132 |
|
Management believes that the methods used to allocate expenses to the companys historical financial statements were reasonable.
NOTE 15 DISCONTINUED OPERATIONS
In December 2014 and August 2015, the company completed the divestitures of its commercial vaccines business and certain vaccines-related R&D programs, respectively. The three months ended March 31, 2015 includes a net after-tax gain of $9 million as a result of a purchase price adjustment related to the December 2014 divestiture of the commercial vaccines business.
As a result of the divestitures, the operations and cash flows of the vaccines business were eliminated from the ongoing operations of the company. The companys results did not include income from discontinued operations during the three months ended March 31, 2016. Following is a summary of the operating results and gain on the sale of the vaccines business during the three months ended March 31, 2015, which have been reflected as discontinued operations.
|
|
Three months ended
|
|
||||
(in millions) |
|
2016 |
|
2015 |
|
||
Net sales |
|
$ |
|
|
$ |
1 |
|
Income from discontinued operations before income taxes, excluding gain on sale |
|
|
|
1 |
|
||
Gain on sale before income taxes |
|
|
|
10 |
|
||
Income tax expense |
|
|
|
(1 |
) |
||
Income from discontinued operations, net of taxes |
|
$ |
|
|
$ |
10 |
|
Exhibit 99.4
SHIRE PLC
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION
On June 3, 2016, Shire plc (Shire) and Baxalta Incorporated (Baxalta), a U.S. biopharmaceutical company based in Bannockburn, Illinois, completed their business combination pursuant to the Agreement and Plan of Merger (the merger agreement), dated as of January 11, 2016, by and among Shire, Baxalta and BearTracks, Inc., a Delaware corporation and wholly-owned subsidiary of Shire.
The unaudited pro forma condensed combined statements of income for the fiscal year ended December 31, 2015 and the three months ended March 31, 2016 have been prepared by Shire and give effect to the following transactions as if they had occurred on January 1, 2015:
· the combination with Baxalta for a consideration of, in each case without interest and subject to any applicable withholding taxes, (i) $18.00 in cash and (ii) (a) 0.1482 of a Shire ADS or (b) if a Baxalta stockholder timely elected, 0.4446 of a Shire ordinary share, in lieu of such fraction of a Shire ADS described in (ii)(a), per share of Baxalta common stock, representing an aggregate consideration of approximately $31.2 billion, based on the closing price of Shire ADSs on May 27, 2016 (the latest practicable date before the date of this Current Report on Form 8-K) and the directly attributable financing of the combination; and
· the acquisition of Dyax Corp. (Dyax) by Shire on January 22, 2016 for consideration of (i) $37.30 in cash per share and (ii) a non-tradable contingent value right of $4.00 per share, payable subject to FDA approval of SHP 643 (formerly known as DX-2930), representing an aggregate preliminary consideration of $6.3 billion, and the directly attributable financing of the acquisition.
The unaudited pro forma condensed combined balance sheet as of March 31, 2016 combines the historical consolidated balance sheets of Shire, which includes the acquisition of Dyax on January 22, 2016, and Baxalta, giving effect to the combination with Baxalta as if it had occurred on March 31, 2016.
Shire has adjusted the historical consolidated financial statements to give effect to pro forma events that are (1) directly attributable to the business combination and acquisition, (2) factually supportable, and (3) with respect to the statement of income expected to have a continuing impact on the combined results. This information should be read in conjunction with:
(i) the accompanying notes to the unaudited pro forma condensed combined financial statements;
(ii) the separate unaudited financial statements of Shire as of and for the three months ended March 31, 2016, included in Shires Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) by Shire on May 4, 2016;
(iii) the separate historical consolidated financial statements of Shire for the year ended December 31, 2015 included in Shires Annual Report on Form 10-K filed with the SEC on February 23, 2016;
(iv) the separate historical financial statements of Dyax as of and for the year ended December 31, 2015 included in Shires amendment to a Current Report on Form 8-K/A on March 17, 2016;
(v) the separate historical unaudited financial statements of Baxalta as of and for the three months ended March 31, 2016 included in Exhibit 99.3 to this Form 8-K; and
(vi) the separate historical financial statements of Baxalta as of and for the year ended December 31, 2015 included in Exhibit 99.2 to this Form 8-K.
Shire funded the cash component of the purchase consideration of approximately $12.37 billion through borrowings under the $18.0 billion bridge facilities agreement with, among others, Barclays Bank PLC and Morgan Stanley Bank International Limited, acting as mandated lead arrangers and book runners (the January 2016
Facilities Agreement), which comprises two credit facilities: (i) a $13.0 billion term loan facility which, subject to a one year extension option exercisable at Shires option, matures on January 11, 2017 (January 2016 Facility A) and (ii) a $5.0 billion revolving loan facility which, subject to a one year extension option exercisable at Shires option, matures on January 11, 2017.
The unaudited pro forma condensed combined financial information has been prepared by management in accordance with SEC Regulation S-X Article 11 for illustrative purposes only. The unaudited pro forma condensed combined financial statements are not necessarily indicative of what the combined companys financial position or results of operations actually would have been had the combination with Baxalta and the acquisition of Dyax been completed as of the dates indicated. In addition, the unaudited pro forma condensed combined financial statements do not purport to project the future financial position or results of operations of the combined entity. There were no material transactions between Shire, Baxalta and/or Dyax (prior to its acquisition by Shire on January 22, 2016) during the period presented in the unaudited pro forma condensed combined financial statements that would need to be eliminated.
The unaudited pro forma condensed combined financial statements have been prepared using the acquisition method of accounting under U.S. generally accepted accounting principles, with Shire being the accounting acquirer. The accounting for the acquisition of Dyax and combination with Baxalta are dependent upon certain valuations that are provisional and are subject to change. Shire will finalize these amounts as it obtains the information necessary to complete the measurement processes. Accordingly, the pro forma adjustments are preliminary and have been made solely for the purpose of providing these unaudited pro forma condensed combined financial statements. Differences between these preliminary estimates and the final acquisition accounting may occur and these differences could be material. The differences, if any, could have a material impact on the accompanying unaudited pro forma condensed combined financial statements and Shires future results of operations and financial position.
In addition, the unaudited pro forma condensed combined financial statements do not reflect any cost savings, operating synergies or revenue enhancements that the combined company may achieve as a result of the combination with Baxalta and the acquisition of Dyax, the costs to integrate the operations of Shire, Baxalta and Dyax or the costs necessary to achieve these cost savings, operating synergies and revenue enhancements.
UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET
AS AT MARCH 31, 2016
|
|
Shire |
|
Baxalta
|
|
Baxalta
|
|
|
|
Baxalta
|
|
|
|
Pro forma
|
|
|
|
$M |
|
$M |
|
$M |
|
Notes |
|
$M |
|
Notes |
|
$M |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
69.0 |
|
911.0 |
|
(12,292.5 |
) |
4(h) |
|
12,223.5 |
|
4(j) |
|
911.0 |
|
Restricted cash |
|
22.3 |
|
|
|
|
|
|
|
|
|
|
|
22.3 |
|
Accounts receivable, net |
|
1,312.7 |
|
1,127.0 |
|
|
|
|
|
|
|
|
|
2,439.7 |
|
Inventories |
|
680.0 |
|
2,237.0 |
|
1,863.0 |
|
4(a) |
|
|
|
|
|
4,780.0 |
|
Prepaid expenses and other current assets |
|
314.4 |
|
601.0 |
|
|
|
|
|
|
|
|
|
915.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
2,398.4 |
|
4,876.0 |
|
(10,429.5 |
) |
|
|
12,223.5 |
|
|
|
9,068.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments |
|
50.4 |
|
122.0 |
|
|
|
|
|
|
|
|
|
172.4 |
|
Property, plant and equipment, net |
|
837.6 |
|
5,208.0 |
|
|
|
|
|
|
|
|
|
6,045.6 |
|
Goodwill |
|
6,881.9 |
|
883.0 |
|
6,656.7 |
|
4(c) |
|
|
|
|
|
14,421.6 |
|
Other intangible assets, net |
|
13,715.6 |
|
1,320.0 |
|
26,680.0 |
|
4(b) |
|
|
|
|
|
41,715.6 |
|
Deferred tax asset |
|
129.1 |
|
|
|
|
|
|
|
|
|
|
|
129.1 |
|
Other non-current assets |
|
42.3 |
|
415.0 |
|
|
|
|
|
|
|
|
|
457.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
24,055.3 |
|
12,824.0 |
|
22,907.2 |
|
|
|
12,223.5 |
|
|
|
72,010.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
1,978.2 |
|
1,645.0 |
|
111.0 |
|
4(e) |
|
112.0 |
|
4(k) |
|
3,846.2 |
|
Short term borrowings |
|
2,211.3 |
|
302.0 |
|
|
|
|
|
12,111.5 |
|
4(j),(k) |
|
14,624.8 |
|
Other current liabilities |
|
157.1 |
|
31.0 |
|
|
|
|
|
|
|
|
|
188.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
4,346.6 |
|
1,978.0 |
|
111.0 |
|
|
|
12,223.5 |
|
|
|
18,659.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long term borrowings |
|
4,654.0 |
|
4,987.0 |
|
322.0 |
|
4(d) |
|
|
|
|
|
9,963.0 |
|
Deferred tax liability |
|
3,543.3 |
|
176.0 |
|
7,844.4 |
|
4(e),(f) |
|
|
|
|
|
11,563.7 |
|
Other non-current liabilities |
|
1,216.7 |
|
1,463.0 |
|
|
|
|
|
|
|
|
|
2,679.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
13,760.6 |
|
8,604.0 |
|
8,277.4 |
|
|
|
12,223.5 |
|
|
|
42,865.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock |
|
59.0 |
|
7.0 |
|
16.8 |
|
4(g),(i) |
|
|
|
|
|
82.8 |
|
Additional paid-in capital |
|
4,507.8 |
|
4,167.0 |
|
14,731.0 |
|
4(g),(i) |
|
|
|
|
|
23,405.8 |
|
Treasury stock |
|
(302.8 |
) |
|
|
|
|
|
|
|
|
|
|
(302.8 |
) |
Accumulated other comprehensive (loss)/income |
|
(159.4 |
) |
(358.0 |
) |
358.0 |
|
4(i) |
|
|
|
|
|
(159.4 |
) |
Retained earnings/(accumulated deficit) |
|
6,190.1 |
|
404.0 |
|
(476.0 |
) |
4(i),(e) |
|
|
|
|
|
6,118.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity |
|
10,294.7 |
|
4,220.0 |
|
14,629.8 |
|
|
|
|
|
|
|
29,144.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity |
|
24,055.3 |
|
12,824.0 |
|
22,907.2 |
|
|
|
12,223.5 |
|
|
|
72,010.0 |
|
UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF INCOME
FOR THE THREE MONTHS ENDED MARCH 31, 2016
|
|
Shire |
|
Baxalta
|
|
Baxalta
|
|
|
|
Dyax |
|
Dyax pro
|
|
|
|
Pro forma
|
|
||
|
|
$M |
|
$M |
|
$M |
|
Notes |
|
$M |
|
$M |
|
Notes |
|
$M |
|
||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Product sales |
|
1,627.3 |
|
1,548.0 |
|
|
|
|
|
4.7 |
|
|
|
|
|
3,180.0 |
|
||
Royalties |
|
79.2 |
|
|
|
|
|
|
|
1.0 |
|
|
|
|
|
80.2 |
|
||
Other revenues |
|
2.8 |
|
|
|
|
|
|
|
0.2 |
|
|
|
|
|
3.0 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Total revenues |
|
1,709.3 |
|
1,548.0 |
|
|
|
|
|
5.9 |
|
|
|
|
|
3,263.2 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Cost of product sales |
|
248.6 |
|
619.0 |
|
|
|
|
|
1.3 |
|
0.5 |
|
5(b) |
|
869.4 |
|
||
Research and development |
|
217.1 |
|
280.0 |
|
|
|
|
|
20.6 |
|
(17.8 |
) |
5(f) |
|
499.9 |
|
||
Selling, general and administrative |
|
609.5 |
|
353.0 |
|
180.0 |
|
4(l) |
|
89.7 |
|
(83.3 |
) |
5(a),(c),(f) |
|
1,148.9 |
|
||
Gain on sale of product rights |
|
(4.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
(4.2 |
) |
||
Reorganization costs |
|
3.3 |
|
76.0 |
|
|
|
|
|
|
|
|
|
|
|
79.3 |
|
||
Integration and acquisition costs |
|
91.1 |
|
25.0 |
|
(54.0 |
) |
4(m) |
|
|
|
(51.7 |
) |
5(c) |
|
10.4 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Total operating expenses |
|
1,165.4 |
|
1,353.0 |
|
126.0 |
|
|
|
111.6 |
|
(152.3 |
) |
|
|
2,603.7 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Operating income/(loss) from continuing operations |
|
543.9 |
|
195.0 |
|
(126.0 |
) |
|
|
(105.7 |
) |
152.3 |
|
|
|
659.5 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Interest income |
|
1.0 |
|
1.0 |
|
|
|
|
|
|
|
|
|
|
|
2.0 |
|
||
Interest expense |
|
(44.7 |
) |
(24.0 |
) |
|
|
|
|
(0.1 |
) |
(5.0 |
) |
5(d),(e) |
|
(73.8 |
) |
||
Other (expense), net |
|
(8.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
(8.5 |
) |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Income/(loss) from continuing operations before income taxes and equity in losses of equity method investees |
|
491.7 |
|
172.0 |
|
(126.0 |
) |
|
|
(105.8 |
) |
147.3 |
|
|
|
579.2 |
|
||
Income taxes |
|
(82.1 |
) |
(27.0 |
) |
37.6 |
|
4(n) |
|
|
|
(9.5 |
) |
5(g) |
|
(81.0 |
) |
||
Equity in losses of equity method investees, net of taxes |
|
(0.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
(0.1 |
) |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Income/(loss) from continuing operations, net of taxes |
|
409.5 |
|
145.0 |
|
(88.4 |
) |
|
|
(105.8 |
) |
137.8 |
|
|
|
498.1 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Earnings per ordinary share from continuing operation - basic |
|
$ |
0.69 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
0.56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Earnings per ordinary share from continuing operations - diluted |
|
$ |
0.69 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
0.56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Weighted average number of shares (millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Basic |
|
591.7 |
|
|
|
303.6 |
|
4(o) |
|
|
|
|
|
|
|
895.3 |
|
||
Diluted |
|
593.3 |
|
|
|
303.6 |
|
4(o) |
|
|
|
|
|
|
|
896.9 |
|
UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF INCOME
FOR THE YEAR ENDED DECEMBER 31, 2015
|
|
Shire |
|
Baxalta
|
|
Baxalta
|
|
|
|
Baxalta
|
|
|
|
Dyax |
|
Dyax pro
|
|
|
|
Pro
|
|
||
|
|
$M |
|
$M |
|
$M |
|
Notes |
|
(Note 4) |
|
Notes |
|
$M |
|
$M |
|
Notes |
|
$M |
|
||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Product sales |
|
6,099.9 |
|
6,148.0 |
|
|
|
|
|
|
|
|
|
66.7 |
|
|
|
|
|
12,314.6 |
|
||
Royalties |
|
300.5 |
|
|
|
|
|
|
|
|
|
|
|
13.5 |
|
|
|
|
|
314.0 |
|
||
Other revenues |
|
16.3 |
|
|
|
|
|
|
|
|
|
|
|
6.9 |
|
|
|
|
|
23.2 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Total revenues |
|
6,416.7 |
|
6,148.0 |
|
|
|
|
|
|
|
|
|
87.1 |
|
|
|
|
|
12,651.8 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Cost of product sales |
|
969.0 |
|
2,332.0 |
|
|
|
|
|
|
|
|
|
16.7 |
|
10.6 |
|
5(b) |
|
3,328.3 |
|
||
Research and development |
|
1,564.0 |
|
1,170.0 |
|
|
|
|
|
|
|
|
|
58.6 |
|
|
|
|
|
2,792.6 |
|
||
Selling, general and administrative |
|
2,341.2 |
|
1,273.0 |
|
740.8 |
|
4(l) |
|
|
|
|
|
64.4 |
|
25.5 |
|
5(a),(c) |
|
4,444.9 |
|
||
Gain on sale of product rights |
|
(14.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14.7 |
) |
||
Reorganization costs |
|
97.9 |
|
193.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
290.9 |
|
||
Integration and acquisition costs |
|
39.8 |
|
(60.0 |
) |
(35.0 |
) |
4(m) |
|
|
|
|
|
|
|
(13.2 |
) |
5(c) |
|
(68.4 |
) |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Total operating expenses |
|
4,997.2 |
|
4,908.0 |
|
705.8 |
|
|
|
|
|
|
|
139.7 |
|
22.9 |
|
|
|
10,773.6 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Operating income/(loss) from continuing operations |
|
1,419.5 |
|
1,240.0 |
|
(705.8 |
) |
|
|
|
|
|
|
(52.6 |
) |
(22.9 |
) |
|
|
1,878.2 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Interest income |
|
4.2 |
|
3.0 |
|
|
|
|
|
|
|
|
|
0.8 |
|
|
|
|
|
8.0 |
|
||
Interest expense |
|
(41.6 |
) |
(51.0 |
) |
|
|
|
|
(349.0 |
) |
4(p) |
|
(8.9 |
) |
(80.2 |
) |
5(d),(e) |
|
(530.7 |
) |
||
Other income, net |
|
3.7 |
|
6.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9.7 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Income/(loss) from continuing operations before income taxes and equity in losses of equity method investees |
|
1,385.8 |
|
1,198.0 |
|
(705.8 |
) |
|
|
(349.0 |
) |
|
|
(60.7 |
) |
(103.1 |
) |
|
|
1,365.2 |
|
||
Income taxes |
|
(46.1 |
) |
(270.0 |
) |
200.0 |
|
4(n) |
|
|
|
|
|
|
|
15.5 |
|
5(g) |
|
(100.6 |
) |
||
Equity in losses of equity method investees, net of taxes |
|
(2.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2.2 |
) |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Income/(loss) from continuing operations, net of taxes |
|
1,337.5 |
|
928.0 |
|
(505.8 |
) |
|
|
(349.0 |
) |
|
|
(60.7 |
) |
(87.6 |
) |
|
|
1,262.4 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Earnings per ordinary share from continuing operation - basic |
|
$ |
2.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Earnings per ordinary share from continuing operations - diluted |
|
$ |
2.26 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Weighted average number of shares (millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Basic |
|
590.4 |
|
|
|
303.6 |
|
4(o) |
|
|
|
|
|
|
|
|
|
|
|
894.0 |
|
||
Diluted |
|
593.1 |
|
|
|
303.6 |
|
4(o) |
|
|
|
|
|
|
|
|
|
|
|
896.7 |
|
NOTES TO THE UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
1. Description of the Baxalta and Dyax transactions
Combination with Baxalta
On January 11, 2016, Shire and Baxalta announced that the boards of directors of both companies reached an agreement under which Shire would combine with Baxalta. Under the merger agreement, Baxalta shareholders received (i) $18.00 in cash and (ii) either 0.1482 of a Shire ADS or 0.4446 of a Shire ordinary share per Baxalta share, without interest and subject to any applicable withholding taxes. The exchange ratio was based on the 30-day trading day volume weighted average price of Shire ADSs of $199.03 as at January 8, 2016, which implied a total value of $47.50 per Baxalta share.
The value of the offer, as at the January 8, 2016 closing price of Shire ADSs, represented a premium of approximately 37.5% to Baxaltas share price on August 3, 2015, the day prior to the public announcement of Shires initial offer for Baxalta. Following the transaction, Baxalta shareholders hold approximately 34% of the equity interests in the combined company.
Acquisition of Dyax
On January 22, 2016, Shire completed the acquisition of Dyax. As consideration, Shire paid $37.30 in cash, without interest and less any required withholding taxes for each share of Dyax common stock outstanding at the time of the acquisition (other than shares owned by Dyax or any of its subsidiaries, and shares owned by shareholders who had properly exercised any available rights of appraisal under Delaware law). Under the terms of the merger agreement Dyax shareholders may receive additional value through a non-tradable contingent value right worth $4.00 per share, payable subject to FDA approval of SHP643 (formerly DX-2930) and certain other conditions set forth in the Contingent Value Rights Agreement.
The preliminary acquisition-date fair value of the purchase consideration is $6,330.0 million, comprised of cash paid on closing of $5,934.0 million and the preliminary fair value of the contingent value right of $396.0 million (maximum payable $646.0 million).
2. Basis of presentation
These unaudited pro forma condensed combined financial statements were prepared using the acquisition method of accounting in accordance with Financial Accounting Standards Boards Accounting Standards Codification (ASC) 805, Business Combinations, with Shire as the accounting acquirer, using the fair value concepts defined in ASC 820, Fair Value Measurements and Disclosures, based on the historical financial statements of Shire, Baxalta and Dyax.
Certain reclassifications have been made to Baxaltas historical consolidated and combined financial statements to conform to Shires presentation as follows:
Reclassifications made to Baxaltas historical condensed consolidated balance sheet as at March 31, 2016:
|
|
Baxalta before
|
|
Reclassifications |
|
|
|
Baxalta after
|
|
|
|
$M |
|
$M |
|
Notes |
|
$M |
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
911.0 |
|
|
|
|
|
911.0 |
|
Accounts receivable, net |
|
1,127.0 |
|
|
|
|
|
1,127.0 |
|
Inventories |
|
2,237.0 |
|
|
|
|
|
2,237.0 |
|
Prepaid expenses and other current assets |
|
601.0 |
|
|
|
|
|
601.0 |
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
4,876.0 |
|
|
|
|
|
4,876.0 |
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
Investments |
|
|
|
122.0 |
|
(1) |
|
122.0 |
|
Property, plant and equipment, net |
|
5,208.0 |
|
|
|
|
|
5,208.0 |
|
Goodwill |
|
883.0 |
|
|
|
|
|
883.0 |
|
Other intangible assets, net |
|
1,320.0 |
|
|
|
|
|
1,320.0 |
|
Other non-current assets |
|
537.0 |
|
(122.0 |
) |
(1) |
|
415.0 |
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
12,824.0 |
|
|
|
|
|
12,824.0 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
427.0 |
|
(427.0 |
) |
(2) |
|
|
|
Accrued liabilities |
|
1,244.0 |
|
(1,244.0 |
) |
(2),(3) |
|
|
|
Accounts payable and accrued expenses |
|
|
|
1,645.0 |
|
(2),(3) |
|
1,645.0 |
|
Current maturities of capital lease obligations |
|
5.0 |
|
(5.0 |
) |
(4) |
|
|
|
Short-term debt |
|
302.0 |
|
|
|
|
|
302.0 |
|
Other current liabilities |
|
|
|
31.0 |
|
(3),(4) |
|
31.0 |
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
1,978.0 |
|
|
|
|
|
1,978.0 |
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
Long term borrowings |
|
5,317.0 |
|
(330.0 |
) |
(5) |
|
4,987.0 |
|
Deferred tax liability |
|
|
|
176.0 |
|
(6) |
|
176.0 |
|
Other non-current liabilities |
|
1,309.0 |
|
154.0 |
|
(5),(6) |
|
1,463.0 |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
8,604.0 |
|
|
|
|
|
8,604.0 |
|
|
|
|
|
|
|
|
|
|
|
Equity: |
|
|
|
|
|
|
|
|
|
Common stock |
|
7.0 |
|
|
|
|
|
7.0 |
|
Additional paid-in capital |
|
4,167.0 |
|
|
|
|
|
4,167.0 |
|
Accumulated other comprehensive loss |
|
(358.0 |
) |
|
|
|
|
(358.0 |
) |
Retained earnings |
|
404.0 |
|
|
|
|
|
404.0 |
|
|
|
|
|
|
|
|
|
|
|
Total equity |
|
4,220.0 |
|
|
|
|
|
4,220.0 |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity |
|
12,824.0 |
|
|
|
|
|
12,824.0 |
|
(1) Reclassification of investments ($122.0 million) from Other non-current assets to Investments.
(2) Reclassification of Accounts payable ($427.0 million) and of Accrued liabilities ($1,218.0 million) to Accounts payable and accrued expenses.
(3) Reclassification of income taxes payable ($26.0 million) from Accrued liabilities to Other current liabilities.
(4) Reclassification of capital lease obligation ($5.0 million) from Current maturities of capital lease obligations to Other current liabilities.
(5) Reclassification of capital lease obligations ($330.0 million) from Long term borrowings to Other non-current liabilities.
(6) Reclassification of deferred tax liability ($176.0 million) from Other non-current liabilities to Deferred tax liability.
Reclassifications made to Baxaltas historical consolidated and combined statements of income for the three months ended March 31, 2016 and the year ended December 31, 2015:
|
|
For the three months ended March 31, 2016 |
|
||||||
|
|
Baxalta before
|
|
Reclassifications |
|
|
|
Baxalta after
|
|
|
|
$M |
|
$M |
|
Notes |
|
$M |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Product sales |
|
1,548.0 |
|
|
|
|
|
1,548.0 |
|
Royalties |
|
|
|
|
|
|
|
|
|
Other revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
1,548.0 |
|
|
|
|
|
1,548.0 |
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
710.0 |
|
(91.0 |
) |
(5),(6),(11) |
|
619.0 |
|
Research and development |
|
280.0 |
|
|
|
(1),(8) |
|
280.0 |
|
Selling, general and administrative |
|
384.0 |
|
(31.0 |
) |
(2),(4),(5),(7) |
|
353.0 |
|
Reorganization costs |
|
|
|
76.0 |
|
(6),(7),(8),(11),(12) |
|
76.0 |
|
Integration and acquisition costs |
|
|
|
25.0 |
|
(3),(4) |
|
25.0 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
1,374.0 |
|
(21.0 |
) |
|
|
1,353.0 |
|
|
|
|
|
|
|
|
|
|
|
Operating income from continuing operations |
|
174.0 |
|
21.0 |
|
|
|
195.0 |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
1.0 |
|
(10) |
|
1.0 |
|
Net interest expense |
|
(23.0 |
) |
(1.0 |
) |
(10) |
|
(24.0 |
) |
Other income/(expense), net |
|
21.0 |
|
(21.0 |
) |
(3),(12) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before income taxes and equity in earnings of equity method investees |
|
172.0 |
|
|
|
|
|
172.0 |
|
Income taxes |
|
(27.0 |
) |
|
|
|
|
(27.0 |
) |
|
|
|
|
|
|
|
|
|
|
Income from continuing operations, net of taxes |
|
145.0 |
|
|
|
|
|
145.0 |
|
|
|
For the years ended December 31, 2015 |
|
||||||
|
|
Baxalta before
|
|
Reclassifications |
|
|
|
Baxalta after
|
|
|
|
$M |
|
$M |
|
Notes |
|
$M |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Product sales |
|
6,148.0 |
|
|
|
|
|
6,148.0 |
|
Royalties |
|
|
|
|
|
|
|
|
|
Other revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
6,148.0 |
|
|
|
|
|
6,148.0 |
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
2,386.0 |
|
(54.0 |
) |
(5),(6),(9) |
|
2,332.0 |
|
Research and development |
|
1,176.0 |
|
(6.0 |
) |
(1),(8) |
|
1,170.0 |
|
Selling, general and administrative |
|
1,442.0 |
|
(169.0 |
) |
(2),(4),(5),(7),(9) |
|
1,273.0 |
|
Reorganization costs |
|
|
|
193.0 |
|
(1),(2),(6),(7),(8) |
|
193.0 |
|
Integration and acquisition costs |
|
|
|
(60.0 |
) |
(3),(4) |
|
(60.0 |
) |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
5,004.0 |
|
(96.0 |
) |
|
|
4,908.0 |
|
|
|
|
|
|
|
|
|
|
|
Operating income from continuing operations |
|
1,144.0 |
|
96.0 |
|
|
|
1,240.0 |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
3.0 |
|
(10) |
|
3.0 |
|
Net interest expense |
|
(48.0 |
) |
(3.0 |
) |
(10) |
|
(51.0 |
) |
Other income/(expense), net |
|
102.0 |
|
(96.0 |
) |
(3),(4) |
|
6.0 |
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before income taxes and equity in earnings of equity method investees |
|
1,198.0 |
|
|
|
|
|
1,198.0 |
|
Income taxes |
|
(270.0 |
) |
|
|
|
|
(270.0 |
) |
|
|
|
|
|
|
|
|
|
|
Income from continuing operations, net of taxes |
|
928.0 |
|
|
|
|
|
928.0 |
|
(1) Reclassification of business optimization charges of $nil for the three months ended March 31, 2016 and ($9.0) million net credit for the year ended December 31, 2015 from Research and development expenses to Reorganization costs.
(2) Reclassification of business optimization charges of $nil million for the three months ended March 31, 2016 and $1.0 million for the year ended December 31, 2015 from Selling, general and administrative expenses to Reorganization costs.
(3) Reclassification of changes in the fair value of contingent consideration of ($1.0) million net credit for the three months ended March 31, 2016 and ($97.0) million net credit for the year ended December 31, 2015 from Other expense, net to Integration and acquisition costs.
(4) Reclassification of acquisition related costs of $26.0 million for the three months ended March 31, 2016 and $37.0 million for the year ended December 31, 2015 from Selling, general and administrative expenses ($26.0 million and $36.0 million respectively) and from Other income/(expense), net ($nil million and $1.0 million respectively ) to Integration and acquisition costs.
(5) Reclassification of amortization expense of $19.0 million for the three months ended March 31, 2016 and $53.0 million for the year ended December 31, 2015 from Cost of product sales to Selling, general and administrative expenses.
(6) Reclassification of separation costs of $6.0 million for the three months ended March 31, 2016 and $20.0 million for the year ended December 31, 2015 from Cost of product sales to Reorganization costs.
(7) Reclassification of separation costs of $24.0 for the three months ended March 31, 2016 and $166.0 million for the year ended December 31, 2015 from Selling, general and administrative expenses to Reorganization costs.
(8) Reclassification of separation costs of $nil for the three months ended March 31, 2016 and $15.0 million for the year ended December 31, 2015 from Research and development expenses to Reorganization costs.
(9) Reclassification of shipping costs of $19.0 million from Selling, general and administrative expenses to Cost of product sales. Shire does not have sufficient information to make the necessary adjustment of shipping costs for the three months ended March 31, 2016.
(10) Reclassification of interest income of $1.0 million for the three months ended March 31, 2016 and $3.0 million for the year ended December 31, 2015 from Net interest expense to Interest income.
(11) Reclassification of business optimization charges of $66 million for the three months ended March 31, 2016 and $nil for the year ended December 31, 2015 from Cost of product sales to Reorganization costs.
(12) Reclassification of separation costs of $20.0 million net credit for the three months ended March 31, 2016 and $nil for the year ended December 31, 2015 from Other income/(expense), net to Reorganization costs.
Further review of Baxaltas detailed accounting policies may identify additional differences between the accounting policies of the two companies that, when conformed, could have a material impact on the financial statements of the combined company. At this time, Shire is not aware of any differences that would have a material impact on the financial statements of the combined company, other than the presentation differences outlined above.
The unaudited pro forma condensed combined financial statements do not assume any differences in accounting policies between Shire and Dyax. Further review of Dyaxs detailed accounting policies may identify additional differences between the accounting policies of the two companies that, when conformed, could have a material impact on the financial statements of the combined company. At this time, Shire is not aware of any differences that would have a material impact on the financial statements of the combined company.
Under ASC 805, acquisition related transaction costs are not included as a component of consideration transferred but are accounted for as expenses in the periods in which the costs are incurred. Total combination related transaction costs (excluding financing fees payable) in connection with the Baxalta combination are estimated to be approximately $200.0 million. This estimate includes transaction related costs to be incurred by Baxalta, which are estimated to be approximately $85.0 million (of which $46.0 million have already been accrued or paid in the historical financial statements).
These anticipated costs for Shire are reflected in the unaudited pro forma condensed combined balance sheet as a reduction to retained earnings and an increase in accrued liabilities. The anticipated transaction costs for Baxalta are reflected in the unaudited pro forma condensed combined balance sheet as a reduction to net assets acquired and an increase in accrued liabilities.
3. Estimate of Consideration Expected to be Transferred in Connection with the Combination with Baxalta
The following is a preliminary estimate of the consideration expected to be paid to effect the combination with Baxalta:
Purchase Consideration
In millions except per share amounts
Estimate of share consideration expected to be transferred to Baxalta shareholders |
|
|
|
|
|
|
Number of Baxalta shares outstanding as at March 31, 2016 |
|
682.8 |
|
|
|
|
Number of Baxalta and Baxter non-employee director equity awards expected to be converted to Shire ADSs |
|
0.1 |
|
|
|
|
Multiplied by the conversion ratio |
|
0.1482 |
|
|
|
|
|
|
|
|
|
|
|
Shire ADSs expected to be issued |
|
101.2 |
|
|
|
|
Closing price of Shire ADSs on May 27, 2016 |
|
$ |
186.96 |
|
|
|
|
|
|
|
|
|
|
Estimated fair value of share consideration |
|
$ |
18,921.8 |
|
A |
|
|
|
|
|
|
|
|
Shares of Shire common stock expected to be issued |
|
303.6 |
|
|
|
|
|
|
|
|
|
|
|
Estimate of cash consideration expected to be transferred to Baxalta shareholders |
|
|
|
|
|
|
Number of Baxalta shares outstanding as at March 31, 2016 |
|
682.8 |
|
|
|
|
Number of Baxalta and Baxter non-employee director equity awards expected to be converted to Shire ADSs |
|
0.1 |
|
|
|
|
Multiplied by cash consideration per Baxalta share outstanding |
|
$ |
18.0 |
|
|
|
|
|
|
|
|
|
|
Estimated fair value of cash consideration |
|
$ |
12,292.5 |
|
B |
|
|
|
|
|
|
|
|
Estimated fair value of total consideration to be transferred |
|
$ |
31,214.3 |
|
C |
|
For the purposes of these unaudited pro forma condensed combined financial statements, the fair value of share consideration to be transferred is estimated using the closing price of Shire ADSs of $186.96 per Shire ADS as at May 27, 2016, the latest practicable date before the date of this Current Report on Form 8-K .
The estimated consideration for Shires combination with Baxalta reflected in these unaudited pro forma condensed combined financial statements does not purport to represent the actual consideration when the combination with Baxalta is consummated. In accordance with ASC 805, the fair value of equity securities issued as part of the consideration paid will be measured on the closing date of the combination at the then-current market price. This requirement will likely result in a per share equity component different from the $27.7 assumed in these unaudited pro forma condensed combined financial statements, and that difference may be material. An increase or decrease in
the price per Shire ADS assumed in these unaudited pro forma condensed combined financial statements by 30% will increase or decrease the estimated purchase price by approximately $5.7 billion, which would be reflected in these unaudited pro forma condensed combined financial statements as an increase or decrease in goodwill.
Pursuant to the terms of the merger agreement, at the effective date of the combination all in-the-money equity awards held by non-employee directors of Baxalta or Baxter, whether vested or unvested, were exchanged for the same consideration paid to common stockholders. Accordingly the estimated cash and equity consideration payable as a result of the conversion of non-employee directors has been reflected in the estimated purchase consideration.
All other Baxalta equity awards outstanding at the effective date of the combination were replaced with Shire equity awards. In accordance with ASC 805, the fair value of these replacement equity awards will be bifurcated between purchase consideration and post-acquisition share-based payment expense based, amongst other things, on the completion date fair values of both the original and replacement unvested equity awards and the length of pre- and post-vesting service periods. Shire estimates the fair value of unvested Baxalta Restricted Stock Units would be approximately $210 million as at March 31, 2016. This fair value would be allocated between purchase consideration transferred and post-combination compensation expense. However at this time Shire does not have sufficient information to determine the pre-and post-combination service periods to determine this allocation. Additionally, at this time Shire does not have sufficient information to determine the combination-date fair values of other Baxalta equity awards outstanding, and thus is unable to determine the allocation between consideration transferred and post-combination compensation expense. Accordingly, the unaudited pro forma condensed combined financial statements do not reflect the effect of issuing replacement equity awards in either the preliminary estimated purchase consideration or the unaudited pro forma condensed combined statements of income.
Shire will calculate the fair value of all Baxalta equity awards outstanding and the replacement Shire equity awards as of the actual acquisition date, in accordance with ASC 718, Compensation Stock Compensation. This will result in the recognition of an incremental component of purchase consideration transferred which is not currently reflected in the preliminary estimate of purchase consideration. In addition, this calculation will be used to determine the fair value amounts related to unvested replacement Shire equity awards which will be recorded as post-combination compensation expense, which is not currently reflected in the unaudited pro forma condensed combined statements of income.
However, in order to illustrate the potential impact on the purchase consideration transferred, Shire has estimated the intrinsic value of the Baxalta equity awards outstanding as of December 31, 2015 based on information disclosed in Baxaltas Form 10-K, which is the most recent publicly available information.
Based on the intrinsic value, Shire estimates a potential increase to the estimated purchase consideration (which would give rise to an equivalent increase in goodwill in the pro forma balance sheet) of approximately $609.4 million related to Baxalta options outstanding as of December 31, 2015, calculated as follows:
|
|
Number of
|
|
Weighted-
|
|
Per Share Offer Price |
|
Intrinsic
|
|
Estimated
|
|
||||
Options |
|
37.7 |
|
$ |
29.55 |
|
$ |
45.71 |
|
$ |
16.16 |
|
$ |
609.4 |
|
(a) Intrinsic value used as an approximation of fair value for illustrative purposes only.
Preliminary purchase price allocation
Assuming a closing date of Shires combination with Baxalta of March 31, 2016 the following table sets forth a preliminary estimate of the fair value of the assets acquired and liabilities assumed by Shire, reconciled to the total estimated consideration transferred:
|
|
Note |
|
$M |
|
Cash and cash equivalents |
|
|
|
911.0 |
|
Accounts receivable, net |
|
|
|
1,127.0 |
|
Inventories |
|
(a) |
|
4,100.0 |
|
Prepaid expenses and other current assets |
|
|
|
601.0 |
|
Property, plant and equipment, net |
|
(c) |
|
5,208.0 |
|
Investments |
|
|
|
122.0 |
|
Other intangible assets, net |
|
(b) |
|
28,000.0 |
|
Other non-current assets |
|
|
|
415.0 |
|
Accounts payable and accrued expenses |
|
|
|
(1,684.0 |
) |
Short-term borrowings |
|
|
|
(302.0 |
) |
Other current liabilities |
|
|
|
(31.0 |
) |
Long term borrowings |
|
(d) |
|
(5,309.0 |
) |
Deferred tax liability |
|
(f) |
|
(8,020.4 |
) |
Other non-current liabilities |
|
(e) |
|
(1,463.0 |
) |
|
|
|
|
|
|
Goodwill |
|
(g) |
|
7,539.7 |
|
|
|
|
|
|
|
Estimate of consideration expected to be transferred |
|
|
|
31,214.3 |
|
(a) A preliminary fair value estimate of $4,100.0 million has been assigned to inventories to be acquired. The pro forma fair value adjustment to inventories to be acquired is based on the book value of Baxaltas inventories as of March 31, 2016 adjusted as follows based on Shire managements estimates using the following methods:
i. Finished goods at estimated selling prices less the sum of costs of disposal and a reasonable profit allowance for the selling effort of a market participant;
ii. Work in process at estimated selling prices of finished goods less the sum of costs to complete the manufacturing of the relevant product, costs of disposal, and a reasonable profit allowance for the completing and selling effort of a market participant ; and
iii. Raw materials at current replacement costs.
Assumptions as to the nature of the products, the margins to be achieved, the value of the selling effort and the stage of completion of work in process inventories have been made by Shire in determining the fair value estimate of Baxaltas inventories for purposes of these unaudited pro forma condensed combined financial statements. The estimated fair value adjustment is preliminary, subject to change and could vary, potentially materially, from the actual fair value adjustment that will be calculated as Shire finalizes its valuation of Baxaltas inventories following the completion of the combination.
(b) A preliminary fair value estimate of $28,000.0 million has been assigned to intangible assets acquired, primarily consisting of currently marketed product rights and in-process research and development (IPR&D). At the date of consummation of the combination, identifiable intangible assets are required to be measured at fair value and these acquired assets may include assets that are not intended to be used or sold or that are intended to be used in a manner other than their highest and best use. For purposes of these unaudited pro forma condensed combined financial statements, it is assumed that all assets will be used and that all assets will be used in a manner that represents the highest and best use of those assets.
The fair value of identifiable intangible assets is determined primarily using the income method, which starts with a forecast of all the expected future net cash flows. Some of the more significant assumptions inherent in the development of intangible asset values, from the perspective of a market participant, include: the amount and timing of projected future cash flows (including revenue, cost of sales, research and development costs, sales and marketing expenses, working capital/contributory asset charges and income taxes), the discount rate selected to measure the risks inherent in the future cash flows, and other factors.
The estimated fair value of the identifiable intangible assets and a preliminary estimate of their weighted average useful lives are as follows:
|
|
Estimated fair |
|
Weighted Average
|
|
(in millions) |
|
value |
|
life |
|
Currently marketed product rights |
|
25,400.0 |
|
32 years |
|
In-process research and development * |
|
2,600.0 |
|
N/A |
|
|
|
|
|
|
|
Total |
|
28,000.0 |
|
|
|
* Acquired IPR&D assets are initially recognized at fair value and are classified as indefinite lived assets until the successful completion or abandonment of the associated research and development efforts. Accordingly, during the development period after the closing date of the combination, these assets will not be amortized into earnings; instead these assets will be subject to periodic impairment testing. Upon successful completion of the development process for an acquired IPR&D project, determination as to the useful life of the asset will be made; at that point in time, the asset would then be considered a finite lived intangible asset and Shire would begin to amortize the asset into earnings.
These preliminary estimates of fair value and weighted average useful life could potentially be different from those determined through the final acquisition accounting, and the difference could potentially have a material impact on the accompanying unaudited pro forma condensed combined financial statements. As Shire obtains additional information in respect of the Baxalta intangible assets, additional insight could be gained which could impact (i) the estimated total value assigned to intangible assets, (ii) the estimated allocation of value between finite lived and indefinite lived intangible assets and/or (iii) the estimated weighted average useful life of each category of intangible assets. The estimated intangible asset fair values and their useful lives could be impacted by a variety of factors that may become known to us only upon access to additional information and/or by changes in such factors that may occur prior to the effective time
of the merger. These factors include but are not limited to the regulatory, legislative, legal, technological and competitive environments. Increased knowledge about these and/or other elements could result in a change to the estimated fair value of the Baxaltas intangible assets and/or to the estimated weighted average useful lives from that assumed by Shire in these unaudited pro forma condensed combined financial statements. The combined effect of any such changes could then also result in a significant increase or decrease to our estimate of associated amortization expense .
(c) As Shire does not currently have sufficient information to reliably determine fair value, the current book value of $5,208.0 million has been used to approximate the preliminary fair value of property, plant and equipment to be acquired, primarily consisting of land, buildings, machinery and equipment and construction in progress. At date of consummation of the combination, property, plant and equipment is required to be measured at fair value, unless those assets are classified as held-for-sale on the closing date of the combination. The acquired assets can include assets that are not intended to be used or sold, or that are intended to be used in a manner other than their highest and best use. Shire has only limited information at this time as to the specific nature, age, condition or location of the land, buildings, machinery and equipment, and construction-in-progress. All of these factors can cause differences between the fair value and net book value, and such differences could be material.
(d) The preliminary fair value estimate of $5,309.0 million has been assigned to Baxaltas debt to be assumed as part of the combination.
(e) Primarily includes capital lease obligations, pension liabilities and assumed contingent consideration liabilities with a preliminary fair value estimate of $330.0 million, $524.0 million and $448.0 million respectively, after consideration of the fair value information included in Baxalta consolidated financial statements for the three months ended March 31, 2016.
(f) The preliminary estimate of deferred income tax liabilities primarily resulting from the fair value adjustments for acquired inventory and identifiable intangible assets. This estimate was determined based on the excess book basis over the tax basis of the assets acquired at an estimated 28% weighted average statutory tax rate. This estimate of deferred income tax liabilities is preliminary and is subject to change based upon Shires final determination of the fair values of assets acquired and liabilities assumed and the statutory tax rates in the jurisdictions where the fair values are expected to occur.
(g) Goodwill is calculated as the difference between the fair value of the consideration expected to be transferred and the fair values assigned to the assets acquired and liabilities assumed. Goodwill is not amortized and is not expected to be deductible for tax purposes.
The accounting for the combination with Baxalta is dependent upon certain valuations that are provisional and are subject to change. Shire will finalize these amounts as it obtains the information necessary to complete the measurement processes. Accordingly, the pro forma adjustments are preliminary and have been made solely for the purpose of providing these unaudited pro forma condensed combined financial statements. Differences between these preliminary estimates and the final acquisition accounting may occur and these differences could be material. The differences, if any, could have a material impact on the accompanying unaudited pro forma condensed combined financial statements and Shires future results of operations and financial position.
4. Pro Forma Adjustments in Connection with the Combination with Baxalta
The Baxalta pro forma adjustments reflected in the unaudited condensed combined financial statements represent estimated values and amounts based on available information and do not reflect anticipated synergies had the combination been completed as at the dates indicated above. The unaudited pro forma condensed combined balance sheet reflects the combination using the acquisition method of accounting as at March 31, 2016, and the unaudited pro forma condensed combined statements of income reflect the combination using the acquisition method as at January 1, 2015.
This note should be read in conjunction with Note 1. Description of Transaction ; Note 2. Basis of Presentation ; and Note 3. Estimate of Consideration Expected to be Transferred .
Pro forma adjustments to the condensed combined balance sheet as at March 31, 2016 :
Adjustments included in the column under the heading Baxalta acquisition adjustments represent the following:
(a) Inventory
Represents the adjustment required to record Baxaltas inventory at its estimated fair value. This estimated step-up in inventory value is preliminary, subject to change and could vary materially from the actual step-up in value calculated after consummation of the combination. Shire will reflect the increased value of inventory in cost of product sales as the acquired inventory is sold which, for purposes of these unaudited pro forma condensed combined financial statements, is assumed to occur within the first year after the combination. As there is no continuing impact of the inventory step-up on Shires results, the impact on cost of product sales of the unwind of the step-up in value of acquired inventory is not included in the unaudited pro forma condensed combined statement of income.
(b) Intangible assets
Represents the adjustment required to record acquired intangible assets to their estimated preliminary fair value of ($28,000.0 million), and to eliminate the book value of Baxaltas historical intangible assets ($1,320.0 million).
(c) Goodwill
Represents the adjustment required to record the preliminary estimate of goodwill arising from the combination ($7,539.7 million) and to eliminate the book value of Baxaltas historical goodwill ($883.0 million).
(d) Long-term borrowings
Represents the adjustment required to record Baxaltas long-term borrowings to their estimated preliminary fair value.
(e) Combination related costs
Represents estimated transaction costs (excluding costs associated with acquisition financing) to be incurred by Shire ($72.0 million) and Baxalta ($39.0 million) related to the combination of $111.0 million that were not previously recorded in the historical combined financial statements, and estimated related taxes of $28.5 million.
As there is no continuing impact of the combination related costs, the impact of these costs is not included in the unaudited pro forma condensed combined statement of income.
(f) Deferred tax liabilities
Reflects the estimated adjustment to deferred income tax liabilities primarily resulting from the fair value adjustments for acquired inventory and identifiable intangible assets. This estimate was determined based on the excess book basis over the tax basis of the assets acquired at an estimated 28% weighted average statutory tax rate. This estimate of deferred income tax liabilities is preliminary and is subject to change based upon Shires final determination of the fair values of assets acquired and liabilities assumed and the statutory tax rates in the jurisdictions where the fair values are expected to occur.
(g) Estimated Stock Consideration Expected to be Transferred
Represents the adjustment to record the equity portion of the merger consideration, at fair value as follows:
|
|
Common Stock,
|
|
Common Stock
|
|
Additional paid-in
|
|
Total Equity ($) |
|
|
|
(in millions) |
|
||||||
|
|
|
|
|
|
|
|
|
|
Shares of Shire common stock expected to be issued |
|
303.6 |
|
23.8 |
|
18,898.0 |
|
18,921.8 |
|
(h) Estimated Cash Consideration Expected to be Transferred
Represents the adjustment required to record the cash portion of the merger consideration estimated to be $12,292.5 million.
(i) Shareholders equity
Represents the adjustment to eliminate Baxaltas historical shareholders equity, and to record an estimate of the remaining combination-related costs to be incurred by Shire (assumed to be non-recurring), as follows:
*Combination-related costs are not reflected in the unaudited pro forma condensed combined statement of income as they are not expected to have an on-going impact.
Adjustments included in the column under the heading Baxalta financing adjustments represent the following:
(j) Acquisition financing
Shire has secured an $18.0 billion, 12 month fully underwritten Bridge Facility (with a one-year extension option exercisable at Shires discretion), which we refer to as the Bridge Facility, to finance the combination with Baxalta, of which $13.0 billion is available to fund the cash consideration payable and certain related costs in respect of the combination with Baxalta and $5.0 billion is available to finance the redemption of Baxaltas senior notes, if required. After the closing date of the combination Shire intends to re-finance borrowings under the Bridge Facility in due course. The financing of the transaction has been structured with the intention of maintaining an investment grade credit rating for the combined company. For the purposes of the unaudited pro forma condensed combined financial statements, it has been assumed that the Bridge Facility will be used solely to fund the cash consideration payable in respect of the acquisition (estimated at $12,223.5 million). The unaudited pro forma condensed combined balance sheet presents the borrowings under the Bridge Facility as short-term borrowings.
Adjustments arising from any potential redemption of Baxaltas existing borrowings are excluded from the unaudited pro forma condensed combined financial information since such redemption is not certain at the time of preparation of these pro forma condensed combined financial statements and is not considered directly attributable to the combination with Baxalta.
(k) Financing costs
Represents financing related transaction fees expected to be incurred (estimated at $112.0 million), all of which are expected to be initially capitalized in short-term borrowings as debt issuance costs associated with the underwritten Bridge Facility.
Pro forma adjustments to the condensed combined statements of income, relating to the combination with Baxalta, for the three months ended March 31, 2016 and for the year ended December 31, 2015
Adjustments included in the column under the heading Baxalta acquisition adjustments represent the following:
(l) Amortization of intangibles
To adjust amortization expense to include an estimate of intangible asset amortization based on an estimated weighted average useful life of 32 years for acquired definite lived intangible assets, as follows:
|
|
Three months |
|
Year ended |
|
(in millions) |
|
ended March 31,
|
|
December 31,
|
|
Estimated amortization of acquired product rights |
|
199.0 |
|
793.8 |
|
Eliminate Baxaltas historical intangible assets amortization expense |
|
(19.0 |
) |
(53.0 |
) |
|
|
|
|
|
|
Total |
|
180.0 |
|
740.8 |
|
(m) Combination related costs
Represents the adjustment to eliminate combination related costs incurred by Shire of $28.0 million for the three months ended March 31, 2016 and $15.0 million for the year ended December 31, 2015 and by Baxalta of $26.0 million for the three months ended March 31, 2016 and $20.0 million for the year ended December 31, 2015, which are directly attributable to the pending combination but which are not expected to have a continuing impact.
(n) Income tax
Reflects the estimated income tax impact of the pro forma adjustments, primarily related to amortization of intangible assets and the elimination of transaction costs. An estimated weighted average statutory tax rate of 28% was applied to the applicable pro forma adjustments.
The effective tax rate of the combined company could be significantly different than the weighted average tax rate assumed for purposes of preparing the unaudited pro forma condensed combined financial statements for a variety of factors.
(o) Weighted average number of shares
The unaudited pro forma combined basic and diluted earnings per share from continuing operations for the periods presented have been adjusted by the number of Shire common shares expected to be issued in connection with the combination with Baxalta.
These unaudited pro forma combined basic and diluted earnings per share from continuing operations have not been adjusted to reflect the potential impact on the dilutive number of shares arising as a result of the replacement of unvested Baxalta equity awards with Shire equity based awards as there is currently insufficient information to determine the dilutive impact.
|
|
Three months
|
|
(In millions) |
|
31, 2015 |
|
Adjustment to basic and diluted weighted average number of Shire common shares outstanding |
|
|
|
Number of Shire ADSs expected to be issued at a conversion ratio of 0.1482 per share of Baxalta stock |
|
101.2 |
|
Number of shares of Shire common stock expected to be issued (three shares of common stock to one Shire ADS). |
|
303.6 |
|
Adjustments included in the column under the heading Baxalta financing adjustments represent the following:
(p) Interest expense
Interest expense for the year ended December 31, 2015 consists of contractual interest expense ($237.0 million) and amortization of debt issuance costs ($112.0 million) associated with the Bridge Facility, using a weighted average interest rate of 1.9%.
Shire intends to re-finance borrowings under the Bridge Facility through capital market debt issuances in due course. As the terms of the anticipated capital market debt issuances are uncertain and not considered directly attributable to the combination with Baxalta, no pro forma adjustment has been made for the associated interest expense in the three months ended March 31, 2016.
A 1/8 percent change in the interest rate would result in an increase or a decrease in the pro forma interest expense by $29.5 million for the year ended December 31, 2015.
5. Pro forma adjustments to the condensed combined statements of income, relating to the acquisition of Dyax, for the three months ended March 31, 2016 and for the year ended December 31, 2015
The Dyax pro forma adjustments reflect the acquisition of Dyax using the acquisition method as if the acquisition had been completed as of January 1, 2015. These adjustments represent estimated values and amounts based on available information and do not reflect anticipated synergies had the acquisition been completed as at the date indicated above.
(a) Amortization of intangibles
Represents the amortization expense of definite lived intangible assets acquired of $2.1 million for the period ended January 22, 2016 and $33.8 million for the year ended December 31, 2015, based on estimated fair values and useful lives for the finite lived intangibles acquired of 18 years for KALBITOR product rights and 8 years for contract-based royalty arrangements. Amortization expense has been calculated on a straight-line basis.
(b) Amortization of inventory fair value step-up
Represents the amortization of the step-up in fair value of inventory of $0.5 million for the period ended January 22, 2016 and $10.6 million for the year ended December 31, 2015.
(c) Acquisition related costs
Represents the adjustment to eliminate acquisition related costs incurred by Shire of $51.7 million for the period ended January 22, 2016 and $13.2 million for the year ended December 31, 2015 and by Dyax of $57.7 million for the period ended January 22, 2016 and $8.3 million for the year ended December 31, 2015, which are directly attributable to the combination but which are not expected to have a continuing impact.
(d) Interest expense
Reflects interest expense associated with the $5,600 million drawn down under the November 2015 Facilities Agreement and $209.1 million of additional borrowings under the RCF. Interest expense of $4.0 million for the period ended January 22, 2016 and $67.9 million for the year ended December 31, 2015 has been estimated as if the purchase consideration was paid, and the relevant loans drawn down, on January 1, 2015, using a weighted average interest rate of 1.17%.
A 1/8 percent change in the interest rate would result in an increase or a decrease in the pro forma interest expense by $7.3 million for the year ended December 31, 2015 and by $0.5 million for the three months ended March 31, 2016.
(e) Amortization of debt issue costs
Represents amortization of debt issue costs of $1.0 million for the period ended January 22, 2016 and $12.3 million for the year ended December 31, 2015 that were incurred on arranging the November 2015 Facilities Agreement, assuming the borrowings had occurred on January 1, 2015.
(f) Stock compensation expense
Reflects the adjustment to eliminate stock compensation charges of $17.8 million within Research and development expenses and $27.7 million within Selling, general and administrative expenses recognized in the period ended January 22, 2016 as a result of the accelerated vesting and settlement of Dyaxs outstanding equity awards, which are directly attributable to the acquisition but which have no continuing impact.
(g) Income taxes
Reflects the income tax impact of the pro forma adjustments (based on statutory tax rates in the jurisdictions where these adjustments are reasonably expected to occur), primarily related to the increase in amortization expense and elimination of acquisition related costs.