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): February 11, 2016
Shire plc
(Exact
name of registrant as specified in its charter)
Jersey, Channel Islands
(State or other jurisdiction of incorporation)
0-29630 | 98-0601486 | |
(Commission File Number) | (IRS Employer Identification No.) |
5 Riverwalk, Citywest Business Campus, Dublin
24, Republic of Ireland
(Address of principal executive offices) (Zip code)
Registrant’s 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.):
[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.f13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition
On February 11, 2016, Shire plc issued a press release and published a presentation announcing its financial results for the twelve month period ended December 31, 2015 which are attached hereto, respectively, as Exhibit 99.1 and Exhibit 99.2 and are incorporated by reference herein. The information furnished pursuant to this Item 2.02, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits. The following exhibits are furnished herewith:
99.1 | Press Release dated February 11, 2016 reporting Shire plc’s financial results for the twelve month period ended December 31, 2015 |
99.2 | Presentation dated February 11, 2016 reporting Shire plc’s financial results for the twelve month period ended December 31, 2015 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SHIRE PLC
| ||
By: | /s/ B Mordan | |
Name: | Bill Mordan | |
Title: | Company Secretary |
Dated: February 11, 2016
EXHIBIT INDEX
Number | Description |
99.1 | Press Release dated February 11, 2016 reporting Shire plc’s financial results for the twelve month period ended December 31, 2015 |
99.2 | Presentation dated February 11, 2016 reporting Shire plc’s financial results for the twelve month period ended December 31, 2015 |
Exhibit 99.1
Press Release | ![]() |
Shire delivers record full-year revenue and strong double digit growth in Non GAAP diluted earnings per ADS |
Transformational M&A achieved through NPS and Dyax acquisitions and the announced combination with Baxalta |
Positioned for future growth with most robust pipeline in Shire’s history |
February 11, 2016 – Shire (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the year to December 31, 2015. |
Financial Highlights | Full Year 2015 | Growth(1) | Non GAAP CER(1)(2) |
Product sales | $6,100 million | +5%(3) | +9%(3) |
Product sales excluding INTUNIV® | $6,035 million | +10% | +14% |
Total revenues | $6,417 million | +7% | +11% |
Non GAAP operating income | $2,786 million | +7% | +11% |
US GAAP operating income | $1,420 million | -16% | |
Non GAAP EBITDA margin (excluding royalties & other revenues)(4) | 43% | -1pps(5) | |
US GAAP net income margin(6) | 20% | -37pps(7) | |
Non GAAP diluted earnings per ADS | $11.68 | +10% | +14% |
US GAAP diluted earnings per ADS | $6.59 | -62%(7) | |
Non GAAP cash generation | $2,422 million | +1% | |
Non GAAP free cash flow | $2,222 million | -12% | |
US GAAP net cash provided by operating activities | $2,337 million | -45%(7) | |
(1) Results and percentages compare to the full financial year 2014.
(2) On a Constant Exchange Rate (“CER”) basis, which is a Non GAAP measure.
(3) Product sales including NPS Pharmaceuticals Inc. (“NPS”) acquired on February 21, 2015.
(4) Non GAAP earnings before interest, tax, depreciation and amortization (“EBITDA”) as a percentage of product sales, excluding royalties and other revenues.
(5) Percentage point change (“pps”).
(6) US GAAP net income as a percentage of total revenues.
(7) US GAAP net income margin, diluted earnings per American Depositary Share (“ADS”) and net cash provided by operating activities in 2014 benefited from the receipt of a $1,635 million break fee in relation to the terminated offer for Shire by AbbVie Inc. (“AbbVie”).
The Non GAAP financial measures included within this release are explained on page 33 - 34, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 24 - 30.
Full Year & Recent Highlights:
· | Delivered product sales growth of 10% excluding INTUNIV (14% on a Non GAAP CER basis) driven by the strong performance from VYVANSE®, CINRYZE®, FIRAZYR®, LIALDA®/MEZAVANT®, and the inclusion of GATTEX®/REVESTIVE® and NATPARA®. |
· | Achieved Non GAAP diluted earnings per ADS growth of 10% (14% on a Non GAAP CER basis), exceeding our upgraded guidance provided in Q2 2015, while investing in future growth drivers. |
· | Expanded commercial portfolio with NPS-acquired products, GATTEX/REVESTIVE and NATPARA, and launch of VYVANSE in the Binge Eating Disorder (“BED”) adult indication. |
· | Significantly progressed pipeline, now with 14 programs either in Phase 3 or Phase 3 ready. |
· | Advanced opthalmic portfolio with the US Food and Drug Administration (“FDA”) acceptance of lifitegrast New Drug Application (“NDA”) resubmission on February 4, 2016 with a Prescription Drug User Fee Act (“PDUFA”) date of July 22, 2016, and the acquisition of Foresight Therapeutics, Inc.; SHP607 Phase 2 topline data in Retinopathy of Prematurity expected in mid-2016. |
· | Closed the acquisitions of NPS in February 2015 and Dyax Corp. (“Dyax”) in January 2016. |
· | Reached merger agreement with Baxalta Incorporated (“Baxalta”), which at closing would create the global leader in rare diseases; expected to deliver over $20 billion in annual revenues by 2020. |
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
Flemming Ornskov, M.D. Chief Executive Officer, commented:
“In 2015, we significantly advanced our strategy to become a leading global biotechnology company focused on rare diseases and other specialty conditions. We executed significant acquisitions to deliver best-in-class therapies in our core therapeutic areas, further strengthened our position in rare diseases, and advanced our innovative dry eye treatment, lifitegrast, including the recent FDA acceptance of our NDA resubmission.
As we transformed our business in 2015, we also achieved record full year revenue and strong Non GAAP diluted earnings per ADS growth. I am particularly pleased with our top and bottom-line growth, delivered while we continued our investment in future growth drivers. Importantly, we again demonstrated our ability to accelerate the growth of rare disease assets that we have acquired, most recently with NPS.
Our continued focus on innovation has resulted in Shire entering 2016 with the most robust pipeline in its history, now with 14 programs either in Phase 3 or Phase 3 ready, and with the acquisition of Dyax and the planned combination with Baxalta, we are positioned for global leadership in rare diseases.
We expect to deliver strong results in 2016 as we anticipate generating double digit topline growth and a 7% to 10% increase in Non GAAP diluted earnings per ADS, while continuing to invest behind lifitegrast, Dyax and our pipeline. Our 2016 outlook includes the effect of the Dyax acquisition but excludes the effect of the announced combination with Baxalta.”
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FINANCIAL SUMMARY
Full Year 2015 Unaudited Results from Continuing Operations
Full Year 2015 | Full Year 2014 | |||||||||||||
US GAAP | Adjustments | Non GAAP | US GAAP | Adjustments | Non GAAP | |||||||||
$M | $M | $M | $M | $M | $M | |||||||||
Total revenues | 6,417 | - | 6,417 | 6,022 | - | 6,022 | ||||||||
Operating income | 1,420 | 1,366 | 2,786 | 1,698 | 895 | 2,593 | ||||||||
Diluted earnings per ADS | $6.59 | $5.09 | $11.68 | $17.28 | ($6.68) | $10.60 | ||||||||
· | Product sales excluding INTUNIV were up 10% (up 14% on a Non GAAP CER basis), with growth driven by VYVANSE(1) (up 19% to $1,722 million), CINRYZE (up 23% to $618 million), LIALDA/MEZAVANT (up 8% to $684 million) and FIRAZYR (up 22% to $445 million). GATTEX/REVESTIVE and NATPARA acquired with NPS contributed 3 percentage points, or $166 million of product sales growth. |
Product sales growth in 2015 was held back, as expected, by 4 percentage points due to the foreign exchange headwinds from the strong US dollar, primarily affecting sales of ELAPRASE®, REPLAGAL® and VPRIV®.
· | Total product sales were up 5% on 2014 (up 9% on a Non GAAP CER basis) at $6,100 million (2014: $5,830 million). Total product sales were held back by significantly lower INTUNIV sales (down 80% to $65 million) following the introduction of generic competition from December 2014. |
· | Total revenues were up 7% to $6,417 million (2014: $6,022 million), due to our product sales growth and higher royalties and other revenues (up 65%), primarily $115 million of SENSIPAR® royalties acquired with NPS. |
· | On a Non GAAP basis: |
Operating income increased by 7% in 2015 to $2,786 million (2014: $2,593 million). Higher total revenues (up 7%), were partially offset by higher combined Research & Development expenditure (“R&D”) and Selling, General and Administrative expenditure (“SG&A”) (up 7%). R&D was up 5%, primarily due to the inclusion of NPS R&D costs and the continued advancement of our existing pipeline. SG&A increased 8%, as we invested behind current and anticipated product launches and included NPS operating costs.
We’ve delivered a strong Non GAAP EBITDA margin (excluding royalties and other revenues) of 43% (2014 : 44%), whilst continuing to invest in our expected future growth drivers, including the launch of VYVANSE for moderate to severe BED in adults, ahead of the anticipated approval and launch of lifitegrast in 2016 and behind the launches of GATTEX/REVESTIVE and NATPARA.
On a US GAAP basis (from continuing operations):
Operating income in 2015 was down 16% to $1,420 million (2014: $1,698 million), as 2015 included higher in-process research and development (“IPR&D”) impairment charges ($644 million in 2015 relating to SHP625 and SHP608), and higher intangible asset amortization charges following the acquisition of NPS, which were in part offset by a net credit from changes in the fair value of contingent consideration liabilities ($150 million).
· | Non GAAP diluted earnings per ADS increased 10% to $11.68 (2014: $10.60) primarily due to the higher Non GAAP operating income and the benefit of a lower Non GAAP effective tax rate in 2015. |
On a US GAAP basis diluted earnings per ADS decreased 62% to $6.59 (2014: $17.28) primarily as a result of comparison to strong US GAAP diluted earnings per ADS in 2014 which benefited from the $1,635 million break fee received following AbbVie’s terminated offer for Shire.
· | Cash generation, a Non GAAP measure, was up 1% at $2,422 million (2014: $2,402 million). Higher cash receipts from product sales and royalties in 2015 was almost totally offset by higher operating |
___________________________
(1) Lisdexamfetamine dimesylate (“LDX”) currently marketed as VYVANSE in the US and Canada, VENVANSE® in Latin America and ELVANSE® in certain territories in the EU for the treatment of Attention Deficit Hyperactivity Disorder (“ADHD”) and in the US for the treatment of moderate to severe BED.
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expense payments, including payments in relation to integration, reorganization activities and employee retention payments following AbbVie’s terminated offer for Shire. |
Free cash flow, also a Non GAAP measure, was down 12% to $2,222 million (2014: $2,529 million). Free cash flow in 2014 benefited from the $417 million repayment received from the Canadian revenue authorities.
On a US GAAP basis, net cash provided by operating activities was down 45% to $2,337 million (2014: $4,228 million). Net cash from operating activities in 2014 significantly benefited from the $1,635 million break fee in relation to AbbVie’s terminated offer for Shire and the $417 million repayment received from the Canadian revenue authorities.
· | Net debt (a Non GAAP measure) at December 31, 2015 was $1,459 million (December 31, 2014: net cash $2,119 million). |
On a US GAAP basis, cash and cash equivalents were $136 million at December 31, 2015 (December 31, 2014: $2,982 million).
OUTLOOK
Following our strong revenue growth and double digit Non GAAP diluted earnings per ADS growth in 2015, we expect 2016 to be another strong year of financial performance for Shire.
This outlook includes the effect of the Dyax acquisition, which closed on January 22, 2016, but does not include the effect of the announced combination with Baxalta which is expected to close mid-2016.
We expect product sales to increase by 11% to 14% on a reported basis in 2016, and increase approximately 13% to 17% on a Non GAAP CER basis.
Royalties and other revenues are expected to increase by 5% to 10% in 2016 as we will benefit from a full year of SENSIPAR royalties and the addition of Dyax royalties.
Our Non GAAP gross margin is expected to be in line with 2015 (2015: 85.5%).
In 2016, we expect our combined Non GAAP R&D and SG&A costs to increase in the 12% to 14% range as we absorb the costs associated with Dyax, make commercial investments in support of our anticipated launch of lifitegrast in the second half of 2016, and invest in 14 programs in late stage clinical development.
With the recent close of the Dyax acquisition, funded by a $5.6 billion term loan bank facility, we expect our Non GAAP net interest and other expense to increase by approximately 1.5 to 2 times 2015 levels (2015: $49 million).
For 2016, we expect our effective tax rate on Non GAAP income to be in the range of 16% to 18%, before reverting to the longer term expectations of 17% to 19%.
Taken together, we expect Non GAAP diluted earnings per ADS growth in the 7% to 10% range in 2016 (9% to 13% on a Non GAAP CER basis).
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FINANCIAL SUMMARY
Fourth Quarter 2015 Unaudited Results
Financial Highlights | Q4 2015 | Growth(1) | Non GAAP CER |
Product sales | $1,624 million | +8%(2) | +12%(2) |
Product sales excluding INTUNIV | $1,604 million | +10% | +14% |
Total revenues | $1,716 million | +9% | +13% |
Non GAAP operating income | $764 million | +17% | +19% |
US GAAP operating income | $357 million | -26% | |
Non GAAP EBITDA margin (excluding royalties & other revenues) | 43% | +2pps | |
US GAAP net income margin | 16% | -121pps(3) | |
Non GAAP diluted earnings per ADS | $2.97 | +13% | +15% |
US GAAP diluted earnings per ADS | $1.42 | -87%(3) | |
Non GAAP cash generation | $813 million | +2% | |
Non GAAP free cash flow | $709 million | -21% | |
US GAAP net cash provided by operating activities | $762 million | -70%(3) | |
(1) Percentages compare to equivalent 2014 period.
(2) Product sales including NPS acquired on February 21, 2015.
(3) US GAAP net income margin, diluted earnings per ADS and net cash provided by operating activities in Q4 2014 benefited from the receipt of a $1,635 million break fee in relation to AbbVie’s terminated offer for Shire.
· | Product sales excluding INTUNIV were up 10% (up 14% on a Non GAAP CER basis), with strong growth from VYVANSE (up 18% to $453 million), LIALDA/MEZAVANT (up 9% to $201 million) and FIRAZYR (up 23% to $125 million). GATTEX and NATPARA, acquired with NPS, contributed 4 percentage points or $58 million of product sales growth. |
As anticipated, product sales growth in Q4 2015 was also held back by approximately 4 percentage points due to foreign exchange headwinds from the strong US dollar, primarily affecting sales of ELAPRASE, REPLAGAL and VPRIV.
· | Total product sales were up 8% on Q4 2014 (up 12% on a Non GAAP CER basis) at $1,624 million (Q4 2014: $1,501 million), held back by lower INTUNIV sales (down 58% to $20 million) following the introduction of generic competition in December 2014. |
· | Total revenues were up 9% to $1,716 million (Q4 2014: $1,576 million), as Q4 2015 benefited from SENSIPAR royalties acquired with NPS. |
· | On a Non GAAP basis: |
Operating income increased 17% to $764 million (Q4 2014: $655 million) as combined R&D and SG&A (up 2%) grew at a slower rate than total revenues. R&D decreased by 2% compared to Q4 2014. SG&A increased by 4%, primarily due to the inclusion of NPS operating costs.
Non GAAP EBITDA margin (excluding royalties and other revenues) was 43%, up 2 percentage points compared to Q4 2014 (Q4 2014: 41%).
On a US GAAP basis (from continuing operations):
Operating income was down 26% to $357 million (Q4 2014: $481 million). US GAAP operating income in Q4 2015 included higher IPR&D intangible asset impairment charges ($120 million in 2015 relating to SHP625), charges of $47 million on re-measurement of contingent consideration liabilities primarily in relation to the acquisition of SARcode reflecting our increased confidence in lifitegrast, and higher intangible asset amortization charges on intangible assets acquired with NPS.
· | Non GAAP diluted earnings per ADS increased 13% to $2.97 (Q4 2014: $2.63), primarily due to the higher Non GAAP operating income. |
On a US GAAP basis diluted earnings per ADS decreased 87% to $1.42 (Q4 2014: $11.02), primarily as a result of comparison to the US GAAP diluted earnings per ADS in Q4 2014, which included the
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$1,635 million break fee received following AbbVie’s terminated offer for Shire, and lower US GAAP operating income in Q4 2015.
· | Cash generation, a Non GAAP measure, was up 2% to $813 million compared to $800 million in Q4 2014. Higher cash receipts from product sales and royalties in Q4 2014 was offset by higher operating expense payments, including payments in relation to integration, reorganization activities and employee retention payments following AbbVie’s terminated offer for Shire. |
Free cash flow, a Non GAAP measure, was down 21% to $709 million (Q4 2014: $892 million), as Q4 2014 benefited from the $169 million repayment from the Canadian revenue authorities.
On a US GAAP basis, net cash provided by operating activities was down 70% to $762 million (Q4 2014: $2,555 million), primarily due to comparison against Q4 2014 which included the receipt of the $1,635 million break fee received following AbbVie’s terminated offer for Shire and the $169 million repayment from the Canadian revenue authorities.
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FOURTH QUARTER 2015 AND RECENT PRODUCT AND PIPELINE DEVELOPMENTS
Products
INTUNIV – for the treatment of ADHD
· | Following approval by the European Commission in September 2015, INTUNIV has now been launched in Germany, the UK and Denmark. Additional launches are planned throughout 2016. Once-daily, non-stimulant INTUNIV (guanfacine hydrochloride prolonged release tablets) is approved in Europe for the treatment of ADHD in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. INTUNIV must be used as part of a comprehensive ADHD treatment program, typically including psychological, educational and social measures. |
· | Geographic expansion is further aided by the launch of INTUNIV XR in Canada for the treatment of ADHD in adolescents, which occurred on January 19, 2016, and submission on January 27, 2016 of a marketing application in Japan for the treatment of ADHD in patients 6 to 18 years old. |
Pipeline
SHP606 (lifitegrast) – for the treatment of dry eye disease (“DED”)
· | On October 27, 2015 Shire announced positive topline results from OPUS-3, a phase 3 efficacy and safety study of lifitegrast versus placebo. These data showed OPUS-3 met the primary endpoint of significantly improving patient-reported symptoms of DED from baseline to day 84 (p=0.0007). Additionally, OPUS-3 met the secondary endpoints of symptom improvement from baseline to days 14 and 42 (p<0.0001 for both endpoints). |
· | On January 22, 2016, Shire resubmitted the NDA for lifitegrast with the FDA in response to the complete response letter the company received from the FDA on October 16, 2015 and to include the positive data from OPUS-3. On February 4, 2016, Shire announced that the FDA acknowledged receipt of the resubmission of the NDA. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a PDUFA date of July 22, 2016. |
Shire’s late stage pipeline continues to expand with a total of 14 programs either in Phase 3 or Phase 3-ready, representing the most robust late stage pipeline in Shire’s history. Programs advancing into Phase 3 or Phase 3-ready include:
· | CINRYZE (SHP616) for the treatment of acute antibody mediated rejection. |
· | A subcutaneous formulation of CINRYZE for routine prophylaxis against Hereditary Angiodema (“HAE”) attacks in adolescent and adult patients. |
· | SHP621 for the treatment of adolescents and adults with Eosinophilic Esophagitis. |
· | SHP643 (DX-2930), a Phase 3 fully humanized monoclonal antibody targeting plasma kallikrein for the treatment of HAE, acquired with Dyax in January 2016. |
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OTHER FOURTH QUARTER 2015 DEVELOPMENTS
Proposed combination with Baxalta
· | On January 11, 2016 Shire announced that the boards of directors of both companies have reached an agreement under which Shire will combine with Baxalta. Under the agreement, Baxalta shareholders will receive $18.00 in cash and 0.1482 Shire ADSs per Baxalta share. Based on Shire’s closing ADS price on January 8, 2016, this implied a total current value of $45.57 per Baxalta share, representing an aggregate consideration of approximately $32 billion. The exchange ratio is based on Shire’s 30-day trading day volume weighted average ADS price of $199.03 as of January 8, 2016, which implied a total value of $47.50 per Baxalta share. |
Acquisition of Dyax
· | On January 22, 2016 Shire announced the closing of the acquisition of Dyax for $5.9 billion. With the acquisition, Shire acquired the global rights to DX-2930, a Phase 3, fully humanized monoclonal antibody targeting plasma kallikrein with proof-of-concept Phase 1B efficacy data. These data demonstrate a greater than 90% reduction in HAE attacks compared to placebo in the 300mg/400mg arms in patients with more than 2 attacks in the 3 months prior to study entry. DX-2930 has received Fast Track, Breakthrough Therapy, and Orphan Drug designations by the FDA and has also received Orphan Drug status in the EU. If approved for the prevention of Type 1 and Type 2 HAE, Shire believes that DX-2930 could generate estimated annual global sales of up to $2 billion. |
BOARD AND COMMITTEE CHANGES
On February 10, 2016 Shire announced that David Kappler will step down as Deputy Chairman and Senior Independent Director of the Board of Directors, and that William Burns, Non-Executive Director and member of the Remuneration, Nomination and Science & Technology Committees, will be appointed Senior Independent Director. Both of these changes will be effective upon the conclusion of the Annual General Meeting (“AGM”) to be held on April 28, 2016.
DIVIDEND
In respect of the six months ended December 31, 2015 the Board has resolved to pay an interim dividend of 22.16 US cents per Ordinary Share (2014: 19.09 US cents per Ordinary Share).
Dividend payments will be made in Pounds Sterling to holders of Ordinary Shares and in US Dollars to holders of ADSs. A dividend of 15.32(1) pence per Ordinary Share (2014: 12.51 pence) and 66.48 US cents per ADS (2014: 57.27 US cents) will be paid on April 12, 2016 to shareholders on the register as at the close of business on March 11, 2016.
Together with the first interim payment of 4.21 US cents per Ordinary Share (2014: 3.83 US cents per Ordinary Share), this represents total dividends for 2015 of 26.37 US cents per Ordinary Share (2014: 22.92 US cents per Ordinary Share), an increase of 15% in US Dollar terms.
(1) Translated using a GBP:USD exchange rate of 1.4466.
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ADDITIONAL INFORMATION
The following additional information is included in this press release:
Page | |
Overview of Full Year 2015 Financial Results | 10 |
Financial Information | 15 |
Non GAAP Reconciliation | 24 |
Notes to Editors | 30 |
Forward-Looking Statements | 31 |
Non GAAP Measures | 33 |
Trade Marks | 34 |
For further information please contact:
Investor Relations | |||
- Matthew Osborne | mattosborne@shire.com | +1 781 482 9502 | |
- Sarah Elton-Farr | seltonfarr@shire.com | +44 1256 894157 | |
Media | |||
- Michele Galen | mgalen@shire.com | +1 781 482 1867 | |
- Gwen Fisher | gfisher@shire.com | +1 484 595 9836 | |
- Brooke Clarke | brclarke@shire.com | +44 1256 894829 |
Dial in details for the live conference call for investors at 14:00 GMT / 09:00 EST on February 11, 2016:
UK dial in: | 0808 237 0030 or 020 3139 4830 |
US dial in: | 1 866 928 7517 or 1 718 873 9077 |
International Access Numbers: | Click here |
Password/Conf ID: | 83231093# |
Live Webcast: | Click here |
The quarterly earnings presentation will be available today at 13:00 GMT / 08:00 EST on:
- Shire.com Investors section
- Shire's IR Briefcase in the iTunes Store
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OVERVIEW OF FULL YEAR 2015 FINANCIAL RESULTS
1. Product sales
For the year to December 31, 2015 product sales increased by 5% to $6,099.9 million (2014: $5,830.4 million) and represented 95% of total revenues (2014: 97%).
Year on year growth | US Exit Market Share(2) | ||||||||||
Product sales | Sales $M | Sales | Non GAAP CER(1) | US Rx(2) | |||||||
VYVANSE | 1,722.2 | +19% | +21% | +8% | 17% | ||||||
LIALDA/MEZAVANT | 684.4 | +8% | +10% | +10% | 36% | ||||||
CINRYZE | 617.7 | +23% | +24% | n/a(3) | n/a(3) | ||||||
ELAPRASE | 552.6 | -7% | +4% | n/a(3) | n/a(3) | ||||||
FIRAZYR | 445.0 | +22% | +25% | n/a(3) | n/a(3) | ||||||
REPLAGAL | 441.2 | -12% | +1% | n/a(4) | n/a(4) | ||||||
ADDERALL XR® | 362.8 | -5% | -4% | +10% | 5% | ||||||
VPRIV | 342.4 | -7% | +1% | n/a(3) | n/a(3) | ||||||
PENTASA® | 305.8 | +6% | +6% | -7% | 12% | ||||||
GATTEX/REVESTIVE | 141.7 | n/a | n/a | n/a(3) | n/a(3) | ||||||
INTUNIV | 65.1 | -80% | -79% | -70% | 1% | ||||||
NATPARA | 24.4 | n/a | n/a | n/a(3) | n/a(3) | ||||||
OTHER | 394.6 | -6% | +3% | n/a | n/a | ||||||
Total | 6,099.9 | +5% | +9% | ||||||||
(1) | On a CER basis, which is a Non GAAP measure. |
(2) | This information is an estimate derived from the use of information under license from the following IMS Health information service: IMS NPA Weekly (“IMS NPA”) for the period January 17, 2014 to January 22, 2016. IMS expressly reserves all rights, including rights of copying, distribution and republication. Exit market share represents the average US market share in the month ended December 31, 2015. |
(3) | IMS NPA data not available. |
(4) | Not sold in the US in Q4 2015. |
VYVANSE – ADHD and BED
VYVANSE product sales grew strongly (up 19%) in 2015. Growth was driven by prescription growth in the US (up 8%), the benefit of price increases and to a lesser extent the benefit of stocking in 2015 as compared to destocking in 2014 and growth from international markets. This growth was partially offset by higher sales deductions as a percentage of product sales in 2015 as compared to 2014.
LIALDA/MEZAVANT – Ulcerative Colitis
The 8% growth in product sales for LIALDA/MEZAVANT in 2015 was primarily driven by higher prescription demand (up 10%) and, to a lesser extent, a price increase taken at the beginning of 2015. The growth was partially offset by higher sales deductions as a percentage of sales in 2015 as compared to 2014 and, to a lesser extent, the effect of slight destocking in 2015 compared to stocking in 2014.
CINRYZE – for the prophylactic treatment of HAE
CINRYZE sales were up 23% on 2014, primarily driven by strong growth in patients on therapy and, to a lesser extent, sales also benefited from a price increase taken since 2014.
ELAPRASE – Hunter syndrome
ELAPRASE product sales were down 7% (up 4% on a Non GAAP CER basis) reflecting the negative impact of foreign exchange movements and, to a lesser extent, a lower average price due to pricing pressures and geographic mix. These negative factors were partially offset by higher volumes, primarily due to an increase in the number of patients on therapy.
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FIRAZYR – for the treatment of acute HAE attacks
FIRAZYR product sales were up 22% compared to 2014, driven by a higher number of patients on therapy and, to a lesser extent, the effect of price increases in the US market.
REPLAGAL – Fabry disease
REPLAGAL sales were down 12% compared to 2014 (up 1% on a Non GAAP CER basis), as the benefit of more patients on therapy was more than offset by the negative impact of foreign exchange and, to a lesser extent, pricing pressures.
ADDERALL XR – ADHD
ADDERALL XR product sales were down 5% in 2015, as growth in prescription demand (up 10%) was more than offset by higher sales deductions as a percentage of product sales in 2015 compared to 2014, primarily due to the mix of business.
VPRIV – Gaucher disease
VPRIV product sales were down 7% (up 1% on a Non GAAP CER basis), as sales growth was negatively impacted by foreign exchange and the impact of new competition in the US market partially offset by higher utilization per patient.
PENTASA – Ulcerative Colitis
PENTASA product sales were up 6% as the benefit of price increases was partially offset by higher sales deductions as a percentage of product sales and lower prescription demand in 2015 compared to 2014.
GATTEX – Short Bowel Syndrome (“SBS”)
Shire acquired GATTEX/REVESTIVE through its acquisition of NPS on February 21, 2015, and recorded sales of $142 million in 2015 (up 51% on a pro-forma basis(1)).
(1) Sales prior to February 21, 2015 were recorded by NPS, prior to the acquisition by Shire.
INTUNIV – ADHD
INTUNIV product sales were down 80% compared to 2014, reflecting the impact of generic competitors since December 2014.
NATPARA – Hypoparathyroidism
Shire made NATPARA available on April 1, 2015, after acquiring the product through its acquisition of NPS, and following a strong US launch, sales of $24 million were recorded in 2015.
2. | Royalties |
Product | Royalties to Shire $M | Year on year growth | CER | |
SENSIPAR | 114.5 | n/a | n/a | |
3TC® and ZEFFIX® | 49.1 | +45% | +45% | |
FOSRENOL® | 46.1 | -10% | +3% | |
ADDERALL XR | 26.0 | -10% | -10% | |
INTUNIV | 27.8 | +26% | +26% | |
Other | 37.0 | +50% | +50% | |
Total | 300.5 | +87% | +91% |
Royalty income increased by 87% in 2015 due primarily to the inclusion of royalty income receivable from Amgen Inc. for SENSIPAR (following the acquisition of NPS by Shire in February 2015).
![]() | 11 |
3. | Financial details |
Cost of product sales
2015 | % of product sales | 2014 | % of product sales | ||||
$M | $M | ||||||
Cost of product sales (US GAAP) | 969.0 | 15.9% | 979.3 | 16.8% | |||
Unwind of inventory fair value adjustment | (31.1) | (91.9) | |||||
Costs of employee retention awards following AbbVie's terminated offer for Shire | (7.1) | - | |||||
Depreciation | (46.1) | (57.1) | |||||
Cost of product sales (Non GAAP) | 884.7 | 14.5% | 830.3 | 14.2% | |||
Non GAAP cost of product sales as a percentage of product sales increased by 0.3% in 2015 compared to 2014. Cost of product sales as a percentage of product sales was slightly higher in 2015 than 2014 principally due to the inclusion of lower margin products acquired with NPS.
US GAAP cost of product sales as a percentage of product sales was 0.9% lower than in 2014, as the impact to the inclusion of lower margin products acquired with NPS was more than offset by lower charges on the unwind of fair value adjustments on acquired inventories.
R&D
2015 | % of product sales | 2014 | % of product sales | ||||
$M | $M | ||||||
R&D (US GAAP) | 1,564.0 | 26% | 1,067.5 | 18% | |||
Impairment of IPR&D intangible assets | (643.7) | (190.3) | |||||
Payment in respect of in-licensed and acquired products | - | (12.5) | |||||
Costs of employee retention awards following AbbVie's terminated offer for Shire | (14.5) | - | |||||
Depreciation | (21.7) | (24.5) | |||||
R&D (Non GAAP) | 884.1 | 14% | 840.2 | 14% | |||
Non GAAP R&D increased by $43.9 million,
or 5%, due to the inclusion of NPS costs since February 2015 and increased investment in existing pipeline programs, partially
offset by lower spend on certain programs in 2014 which was not repeated in 2015.
US GAAP R&D increased by $496.5 million, or 47%, as 2015 included higher IPR&D impairment charges compared to 2014, principally an impairment charge of $467 million following negative clinical trial results and the reassessment of the commercial potential for SHP625.
![]() | 12 |
SG&A
2015 | % of product sales | 2014 | % of product sales | ||||
$M | $M | ||||||
SG&A (US GAAP) | 2,341.2 | 38% | 2,025.8 | 35% | |||
Intangible asset amortization | (498.7) | (243.8) | |||||
Legal and litigation costs | (9.5) | (9.2) | |||||
Costs incurred in connection with AbbVie’s terminated offer for Shire (including employee retention awards) | (38.5) | (95.8) | |||||
Depreciation | (70.7) | (81.9) | |||||
SG&A (Non GAAP) | 1,723.8 | 28% | 1,595.1 | 27% | |||
Non GAAP SG&A increased by $128.7 million, or 8%, due to the inclusion of NPS’s SG&A (approximately 5 percentage points of the increase) and increased sales and marketing spend supporting the launch of VYVANSE for the treatment of BED and the anticipated launch of lifitegrast for the treatment of DED.
US GAAP SG&A increased by $315.4 million, or 16%, a higher rate of increase than on a Non GAAP basis, as 2015 included significantly higher amortization of intangible assets acquired with NPS.
Gain on sale of product rights
For the year to December 31, 2015 Shire recorded a net gain on sale of product rights of $14.7 million (2014: $88.2 million) due primarily to the re-measurement of the contingent consideration receivable relating to the divestment of DAYTRANA. In 2014 Shire additionally recorded a net gain on sale of product rights following the divestment of CALCICHEW, VANCOCIN, ESTRACE and EXPUTEX.
Reorganization costs
For the year to December 31, 2015 Shire recorded reorganization costs of $97.9 million (2014: $180.9 million) primarily related to the relocation of roles from Chesterbrook to Lexington. 2014 also included costs relating to the One Shire reorganization, including termination benefits and other reorganization costs.
Integration and acquisition costs
For the year to December 31, 2015 Shire recorded net integration and acquisition costs of $39.8 million, representing acquisition and integration costs of $189.7 million, primarily related to NPS, ViroPharma Incorporated (“ViroPharma”), Baxalta and Dyax. These costs were offset by a net credit of $149.9 million on the change in fair value of contingent consideration liabilities, primarily relating to SHP625 (acquired with Lumena Pharmaceuticals, Inc.) and SHP608 (acquired with Lotus Tissue Repair, Inc.).
In 2014 Shire recorded integration and acquisition costs of $158.8 million, comprising acquisition and integration costs of $144.1 million, primarily related to ViroPharma, and a $14.7 million charge relating to the change in the fair value of contingent consideration liabilities.
Interest expense
For the year to December 31, 2015 Shire incurred interest expense of $41.6 million (2014: $30.8 million). Interest expense in 2015 principally relates to interest and financing costs incurred on facilities drawn down in respect of the acquisition of NPS.
![]() | 13 |
Taxation
The effective tax rate on Non GAAP income in 2015 was 16% (2014: 18%) and the effective tax rate on US GAAP income from continuing operations was 3% (2014: 2%).
The effective rate of tax on Non GAAP income from continuing operations in 2015 is lower than the same period in 2014, primarily due the release of certain valuation allowances, increased research and development credits, the effect of the finalization of various tax returns and changes in profit mix.
In addition to the above factors, the effective rate of tax on US GAAP income from continuing operations in 2015 is low, primarily due to deferred tax movements which do not reduce the Company’s cash tax liability. Excluding the effect of these items, the effective US GAAP tax rate would be approximately 14%.
The effective rate of tax on US GAAP income in 2014 included the non-taxable receipt of the break fee from AbbVie and a net credit to income taxes following the settlement with the Canadian revenue authorities.
Discontinued operations
The loss from discontinued operations for the year to December 31, 2015 was $34.1 million net of tax (2014: gain of $122.7 million). The charge in 2015 primarily related to a change in estimate for onerous lease provisions.
The gain on discontinued operations in 2014 included a tax credit of $211.3 million primarily driven by a tax benefit arising following a reorganization of the Regenerative Medicine business undertaken in Q4 2014, associated with the divestment of the DERMAGRAFT® business in Q1 2014. The gain was partially offset by costs associated with the divestment of the DERMAGRAFT business, including a loss on re-measurement of contingent consideration receivable from Organogenesis Inc. to its fair value.
![]() | 14 |
FINANCIAL INFORMATION
TABLE OF CONTENTS
Page | |
Unaudited US GAAP Consolidated Balance Sheets | 16 |
Unaudited US GAAP Consolidated Statements of Income | 17 |
Unaudited US GAAP Consolidated Statements of Cash Flows | 19 |
Selected Notes to the Unaudited US GAAP Financial Statements | |
(1) Earnings per share | 21 |
(2) Analysis of revenues | 22 |
Non GAAP reconciliation | 24 |
![]() | 15 |
Unaudited US GAAP financial position as of December 31, 2015
and 2014
Consolidated Balance Sheets
December 31, | December 31, | ||
2015 | 2014 | ||
$M | $M | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | 135.5 | 2,982.4 | |
Restricted cash | 86.0 | 54.6 | |
Accounts receivable, net | 1,201.2 | 1,035.1 | |
Inventories | 635.4 | 544.8 | |
Deferred tax asset(1) | - | 344.7 | |
Prepaid expenses and other current assets | 197.4 | 221.5 | |
Total current assets | 2,255.5 | 5,183.1 | |
Non-current assets: | |||
Investments | 50.8 | 43.7 | |
Property, plant and equipment ("PP&E"), net | 828.1 | 837.5 | |
Goodwill | 4,147.8 | 2,474.9 | |
Other intangible assets, net | 9,173.3 | 4,934.4 | |
Deferred tax asset | 121.0 | 112.1 | |
Other non-current assets | 33.3 | 46.4 | |
Total assets | 16,609.8 | 13,632.1 | |
LIABILITIES AND EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued expenses | 2,050.6 | 1,909.4 | |
Short term borrowings | 1,511.5 | 850.0 | |
Other current liabilities | 144.0 | 262.5 | |
Total current liabilities | 3,706.1 | 3,021.9 | |
Non-current liabilities: | |||
Long term borrowings | 69.9 | - | |
Deferred tax liability | 2,205.9 | 1,210.6 | |
Other non-current liabilities | 798.8 | 736.7 | |
Total liabilities | 6,780.7 | 4,969.2 | |
Equity: | |||
Common stock of 5p par value; 1,000 million shares authorized; and 601.1 million shares issued and outstanding (2014: 1,000 million shares authorized; and 599.1 million shares issued and outstanding) | 58.9 | 58.7 | |
Additional paid-in capital | 4,486.3 | 4,338.0 | |
Treasury stock: 9.7 million shares (2014: 10.6 million) | (320.6) | (345.9) | |
Accumulated other comprehensive loss | (183.8) | (31.5) | |
Retained earnings | 5,788.3 | 4,643.6 | |
Total equity | 9,829.1 | 8,662.9 | |
Total liabilities and equity | 16,609.8 | 13,632.1 |
(1) ASU No.2015-17, which requires entities to present deferred tax assets and liabilities as non-current, has been adopted on a prospective basis in 2015.
![]() | 16 |
Unaudited US GAAP results for the three months and year to
December 31, 2015 and 2014
Consolidated Statements of Income
3 months to December 31, | Year to December 31, | ||||||
2015 | 2014 | 2015 | 2014 | ||||
$M | $M | $M | $M | ||||
Revenues: | |||||||
Product sales | 1,623.7 | 1,500.7 | 6,099.9 | 5,830.4 | |||
Royalties | 82.3 | 59.4 | 300.5 | 160.8 | |||
Other revenues | 9.7 | 16.0 | 16.3 | 30.9 | |||
Total revenues | 1,715.7 | 1,576.1 | 6,416.7 | 6,022.1 | |||
Costs and expenses: | |||||||
Cost of product sales | 250.5 | 218.5 | 969.0 | 979.3 | |||
R&D(1) | 353.2 | 241.5 | 1,564.0 | 1,067.5 | |||
SG&A(2) | 632.3 | 576.4 | 2,341.2 | 2,025.8 | |||
Gain on sale of product rights | (1.7) | (2.0) | (14.7) | (88.2) | |||
Reorganization costs | 38.3 | 57.5 | 97.9 | 180.9 | |||
Integration and acquisition costs | 86.6 | 3.0 | 39.8 | 158.8 | |||
Total operating expenses | 1,359.2 | 1,094.9 | 4,997.2 | 4,324.1 | |||
Operating income from continuing operations | 356.5 | 481.2 | 1,419.5 | 1,698.0 | |||
Interest income | 0.8 | 1.9 | 4.2 | 24.7 | |||
Interest expense | (10.0) | (5.1) | (41.6) | (30.8) | |||
Other (expense)/income, net | (8.2) | (5.9) | 3.7 | 8.9 | |||
Receipt of break fee | - | 1,635.4 | - | 1,635.4 | |||
Income from continuing operations before income taxes and equity in (losses)/earnings of equity method investees | 339.1 | 2,107.5 | 1,385.8 | 3,336.2 | |||
Income taxes | (55.1) | (120.8) | (46.1) | (56.1) | |||
Equity in (losses)/earnings of equity method investees, net of taxes | (0.6) | (1.1) | (2.2) | 2.7 | |||
Income from continuing operations, net of tax | 283.4 | 1,985.6 | 1,337.5 | 3,282.8 | |||
(Loss)/gain from discontinued operations, net of taxes | (2.8) | 186.7 | (34.1) | 122.7 | |||
Net income | 280.6 | 2,172.3 | 1,303.4 | 3,405.5 | |||
(1) | R&D includes impairments of IPR&D intangible assets of $120.4 for the three months to December 31, 2015 (2014: $2.3 million) and $643.7 million for the year to December 31, 2015 (2014: $190.3 million). |
(2) | SG&A includes amortization of intangible assets relating to intellectual property rights acquired of $146.4 million for the three months to December 31, 2015 (2014: $61.9 million) and $498.7 million for the year to December 31, 2015 (2014: $243.8 million). |
![]() | 17 |
Unaudited US GAAP results for the three months and year to
December 31, 2015 and 2014
Consolidated Statements of Income (continued)
3 months to December 31, | Year to December 31, | ||||||
2015 | 2014 | 2015 | 2014 | ||||
Earnings per Ordinary Share – basic | |||||||
Earnings from continuing operations | 47.9c | 338.3c | 226.5c | 559.6c | |||
(Loss)/gain from discontinued operations | (0.5c) | 31.8c | (5.8c) | 20.9c | |||
Earnings per Ordinary Share – basic | 47.4c | 370.1c | 220.7c | 580.5c | |||
Earnings per ADS – basic | 142.2c | 1,110.3c | 662.1c | 1,741.5c | |||
Earnings per Ordinary Share – diluted | |||||||
Earnings from continuing operations | 47.8c | 335.7c | 225.5c | 555.2c | |||
(Loss)/gain from discontinued operations | (0.5c) | 31.6c | (5.8c) | 20.8c | |||
Earnings per Ordinary Share – diluted | 47.3c | 367.3c | 219.7c | 576.0c | |||
Earnings per ADS – diluted | 141.9c | 1,101.9c | 659.1c | 1,728.0c | |||
Weighted average number of shares: | |||||||
Millions | Millions | Millions | Millions | ||||
Basic | 591.2 | 586.9 | 590.4 | 586.7 | |||
Diluted | 593.3 | 591.4 | 593.1 | 591.3 |
![]() | 18 |
Unaudited US GAAP results for the three months and year to
December 31, 2015 and 2014
Consolidated Statements of Cash Flows
3 months to December 31, | Year to December 31, | |||||||
2015 | 2014 | 2015 | 2014 | |||||
$M | $M | $M | $M | |||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net income | 280.6 | 2,172.3 | 1,303.4 | 3,405.5 | ||||
Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||
Depreciation and amortization | 179.8 | 100.2 | 637.2 | 407.3 | ||||
Share based compensation | 29.5 | 18.7 | 100.3 | 97.0 | ||||
Change in fair value of contingent consideration | 46.6 | (11.6) | (149.9) | 14.7 | ||||
Impairment of intangible assets | 120.4 | 2.3 | 643.7 | 190.3 | ||||
Gain on sale of product rights | (1.7) | (2.0) | (14.7) | (54.6) | ||||
Unwind of inventory fair value step-up | 8.1 | 1.3 | 31.1 | 91.9 | ||||
Other, net | 15.4 | (1.1) | 12.5 | 29.4 | ||||
Movement in deferred taxes | (19.9) | (77.4) | (198.2) | (14.3) | ||||
Equity in losses/(earnings) of equity method investees | 0.6 | 1.1 | 2.2 | (2.7) | ||||
Changes in operating assets and liabilities: | ||||||||
Decrease/(increase) in accounts receivable | 76.7 | 26.0 | (211.4) | (66.1) | ||||
(Decrease)/increase in sales deduction accrual | (2.4) | 79.4 | 97.6 | 107.6 | ||||
Increase in inventory | (41.5) | (9.5) | (63.2) | (25.3) | ||||
Decrease in prepayments and other assets | 16.0 | 157.1 | 37.2 | 42.4 | ||||
Increase in accounts payable and other liabilities | 53.6 | 98.1 | 109.2 | 5.3 | ||||
Net cash provided by operating activities(A) | 761.8 | 2,554.9 | 2,337.0 | 4,228.4 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Movements in restricted cash | 16.0 | (0.3) | (32.0) | (32.6) | ||||
Purchases of subsidiary undertakings and businesses, net of cash acquired | - | - | (5,553.4) | (4,104.4) | ||||
Purchases of non-current investments | (4.3) | (0.3) | (9.5) | (23.1) | ||||
Purchases of PP&E | (52.6) | (27.2) | (114.7) | (77.0) | ||||
Proceeds from short-term investments | - | - | 67.0 | 57.8 | ||||
Proceeds from disposal of non-current investments | 0.2 | 0.2 | 18.7 | 21.5 | ||||
Proceeds received on sale of product rights | 3.0 | 4.3 | 17.5 | 127.0 | ||||
Other, net | (16.2) | (1.1) | (13.5) | 0.2 | ||||
Net cash used in investing activities(B) | (53.9) | (24.4) | (5,619.9) | (4,030.6) |
![]() | 19 |
Unaudited US GAAP results for the three months and year to
December 31, 2015 and 2014
Consolidated Statements of Cash Flows (continued)
3 months to December 31, | Year to December 31, | ||||||
2015 | 2014 | 2015 | 2014 | ||||
$M | $M | $M | $M | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
Proceeds from revolving line of credit, long term and short term borrowings | 110.0 | - | 3,760.8 | 2,310.8 | |||
Repayment of revolving line of credit and short term borrowings | (624.8) | - | (3,110.9) | (1,461.8) | |||
Repayment of debt acquired through business combinations | - | - | - | (551.5) | |||
Proceeds from ViroPharma call options | - | - | - | 346.7 | |||
Payment of dividend | (24.2) | (21.6) | (134.4) | (121.2) | |||
Excess tax benefit associated with exercise of stock options | 1.9 | 2.3 | 32.4 | 39.7 | |||
Proceeds from exercise of options | 15.8 | 16.2 | 16.6 | 17.4 | |||
Facility arrangement fee | (20.8) | (6.8) | (24.1) | (10.2) | |||
Contingent consideration payments | (92.4) | (2.4) | (101.2) | (15.2) | |||
Other, net | 18.6 | (0.4) | (0.2) | (0.2) | |||
Net cash (used in)/provided by financing activities(C) | (615.9) | (12.7) | 439.0 | 554.5 | |||
Effect of foreign exchange rate changes on cash and cash equivalents (D) | (1.5) | (3.1) | (3.0) | (9.3) | |||
Net (decrease)/increase in cash and cash equivalents(A) +(B) +(C) +(D) | 90.6 | 2,514.7 | (2,846.9) | 743.0 | |||
Cash and cash equivalents at beginning of period | 44.9 | 467.7 | 2,982.4 | 2,239.4 | |||
Cash and cash equivalents at end of period | 135.5 | 2,982.4 | 135.5 | 2,982.4 | |||
![]() | 20 |
Unaudited US GAAP results for the three months and year to December 31, 2015 and 2014
Selected Notes to the Financial Statements
(1) Earnings Per Share (“EPS”)
3 months to December 31, | Year to December 31, | ||||||
2015 | 2014 | 2015 | 2014 | ||||
$M | $M | $M | $M | ||||
Income from continuing operations | 283.4 | 1,985.6 | 1,337.5 | 3,282.8 | |||
(Loss)/gain from discontinued operations | (2.8) | 186.7 | (34.1) | 122.7 | |||
Numerator for EPS | 280.6 | 2,172.3 | 1,303.4 | 3,405.5 | |||
Weighted average number of shares: | |||||||
Millions | Millions | Millions | Millions | ||||
Basic(1) | 591.2 | 586.9 | 590.4 | 586.7 | |||
Effect of dilutive shares: | |||||||
Share based awards to employees(2) | 2.1 | 4.5 | 2.7 | 4.6 | |||
Diluted | 593.3 | 591.4 | 593.1 | 591.3 |
(1) | Excludes shares purchased by the employee benefit trust and under the share buy-back program and presented by Shire as treasury stock. |
(2) | Calculated using the treasury stock method. |
The share equivalents not included in the calculation of the diluted weighted average number of shares are shown below:
3 months to December 31, | Year to December 31, | ||||||
2015 | 2014 | 2015 | 2014 | ||||
Millions | Millions | Millions | Millions | ||||
Share based awards to employees(1) | 3.9 | 0.3 | 3.4 | 0.3 |
(1) | Certain stock options have been excluded from the calculation of diluted EPS because (a) their exercise prices exceeded Shire’s average share price during the calculation period or (b) the required performance conditions were not satisfied as at the balance sheet date. |
![]() | 21 |
Unaudited US GAAP results for the year to December 31, 2015 and 2014
Selected Notes to the Financial Statements
(2) Analysis of revenues
Year to December 31, | 2015 | 2014 | 2015 | 2015 | |||
% | % of total | ||||||
$M | $M | change | revenue | ||||
Net product sales: | |||||||
VYVANSE | 1,722.2 | 1,449.0 | 19% | 27% | |||
LIALDA/MEZAVANT | 684.4 | 633.8 | 8% | 11% | |||
CINRYZE | 617.7 | 503.0 | 23% | 10% | |||
ELAPRASE | 552.6 | 592.8 | -7% | 9% | |||
FIRAZYR | 445.0 | 364.2 | 22% | 7% | |||
REPLAGAL | 441.2 | 500.4 | -12% | 7% | |||
ADDERALL XR | 362.8 | 383.2 | -5% | 6% | |||
VPRIV | 342.4 | 366.7 | -7% | 5% | |||
PENTASA | 305.8 | 289.7 | 6% | 5% | |||
FOSRENOL | 177.6 | 183.0 | -3% | 3% | |||
GATTEX/REVESTIVE | 141.7 | - | n/a | 2% | |||
XAGRID® | 100.8 | 108.5 | -7% | 2% | |||
INTUNIV | 65.1 | 327.2 | -80% | 1% | |||
NATPARA | 24.4 | - | n/a | <1% | |||
Other product sales | 116.2 | 128.9 | -10% | 2% | |||
Total product sales | 6,099.9 | 5,830.4 | 5% | 95% | |||
Royalties: | |||||||
SENSIPAR | 114.5 | - | n/a | 2% | |||
3TC and ZEFFIX | 49.1 | 33.9 | 45% | 1% | |||
FOSRENOL | 46.1 | 51.4 | -10% | 1% | |||
INTUNIV | 27.8 | 22.0 | 26% | <1% | |||
ADDERALL XR | 26.0 | 28.9 | -10% | <1% | |||
Other | 37.0 | 24.6 | 50% | <1% | |||
Total royalties | 300.5 | 160.8 | 87% | 5% | |||
Other revenues | 16.3 | 30.9 | -47% | <1% | |||
Total revenues | 6,416.7 | 6,022.1 | 7% | 100% |
![]() | 22 |
Unaudited US GAAP results for the three months to December 31, 2015 and 2014
Selected Notes to the Financial Statements
(2) Analysis of revenues
3 months to December 31, | 2015 | 2014 | 2015 | 2015 | |||
% | % of total | ||||||
$M | $M | change | revenue | ||||
Net product sales: | |||||||
VYVANSE | 453.3 | 383.4 | 18% | 26% | |||
LIALDA/MEZAVANT | 201.4 | 184.7 | 9% | 12% | |||
CINRYZE | 143.3 | 142.4 | 1% | 8% | |||
ELAPRASE | 147.1 | 143.3 | 3% | 9% | |||
FIRAZYR | 125.2 | 101.9 | 23% | 7% | |||
REPLAGAL | 115.7 | 119.7 | -3% | 7% | |||
ADDERALL XR | 103.1 | 103.0 | 0% | 6% | |||
VPRIV | 86.2 | 93.7 | -8% | 5% | |||
PENTASA | 73.1 | 75.9 | -4% | 4% | |||
FOSRENOL | 44.7 | 46.8 | -4% | 3% | |||
GATTEX/REVESTIVE | 46.5 | - | n/a | 3% | |||
XAGRID | 25.8 | 26.4 | -2% | 2% | |||
INTUNIV | 20.1 | 48.2 | -58% | 1% | |||
NATPARA | 11.6 | - | n/a | <1% | |||
Other product sales | 26.6 | 31.3 | -15% | 2% | |||
Total product sales | 1,623.7 | 1,500.7 | 8% | 95% | |||
Royalties: | |||||||
SENSIPAR | 34.5 | - | n/a | 2% | |||
3TC and ZEFFIX | 19.2 | 9.3 | 106% | 1% | |||
FOSRENOL | 13.7 | 14.6 | -6% | <1% | |||
INTUNIV | - | 22.0 | n/a | 0% | |||
ADDERALL XR | 3.8 | 5.9 | -36% | <1% | |||
Other | 11.1 | 7.6 | 46% | <1% | |||
Total royalties | 82.3 | 59.4 | 39% | 5% | |||
Other revenues | 9.7 | 16.0 | -39% | <1% | |||
Total revenues | 1,715.7 | 1,576.1 | 9% | 100% |
![]() | 23 |
Unaudited results for the year to December 31, 2015
Non GAAP reconciliation
Year to December 31, 2015 | US GAAP | Adjustments | Non GAAP | |||||||
(a) | (b) | (c) | (d) | (e) | (f) | |||||
$M | $M | $M | $M | $M | $M | $M | $M | |||
Total revenues | 6,416.7 | - | - | - | - | - | - | 6,416.7 | ||
Costs and expenses: | ||||||||||
Cost of product sales | 969.0 | - | (31.1) | - | - | (7.1) | (46.1) | 884.7 | ||
R&D | 1,564.0 | (643.7) | - | - | - | (14.5) | (21.7) | 884.1 | ||
SG&A | 2,341.2 | (498.7) | - | - | (9.5) | (38.5) | (70.7) | 1,723.8 | ||
Gain on sale of product rights | (14.7) | - | - | 14.7 | - | - | - | - | ||
Reorganization costs | 97.9 | - | - | (97.9) | - | - | - | - | ||
Integration and acquisition costs | 39.8 | - | (39.8) | - | - | - | - | - | ||
Depreciation | - | - | - | - | - | - | 138.5 | 138.5 | ||
Total operating expenses | 4,997.2 | (1,142.4) | (70.9) | (83.2) | (9.5) | (60.1) | - | 3,631.1 | ||
Operating income | 1,419.5 | 1,142.4 | 70.9 | 83.2 | 9.5 | 60.1 | - | 2,785.6 | ||
Interest income | 4.2 | - | - | - | - | (1.1) | - | 3.1 | ||
Interest expense | (41.6) | - | - | - | - | - | - | (41.6) | ||
Other income/(expense), net | 3.7 | - | - | (14.1) | - | - | - | (10.4) | ||
Income before income taxes and equity in losses of equity method investees | 1,385.8 | 1,142.4 | 70.9 | 69.1 | 9.5 | 59.0 | - | 2,736.7 | ||
Income taxes | (46.1) | (258.4) | (67.9) | (25.8) | (3.5) | (22.7) | - | (424.4) | ||
Equity in losses of equity method investees, net of tax | (2.2) | - | - | - | - | - | - | (2.2) | ||
Income from continuing operations | 1,337.5 | 884.0 | 3.0 | 43.3 | 6.0 | 36.3 | - | 2,310.1 | ||
Loss from discontinued operations, net of tax | (34.1) | - | - | 34.1 | - | - | - | - | ||
Net income | 1,303.4 | 884.0 | 3.0 | 77.4 | 6.0 | 36.3 | - | 2,310.1 | ||
Weighted average number of shares (millions) – diluted | 593.1 | - | - | - | - | - | - | 593.1 | ||
Diluted earnings per ADS | 659.1c | 447.1c | 1.6c | 39.4c | 3.0c | 18.3c | - | 1,168.5c |
The following items are included in Adjustments:
a) | Amortization and asset impairments: Impairment of SHP625 IPR&D intangible asset ($467.0 million), impairment of SHP608 IPR&D intangible asset ($176.7 million), amortization of intangible assets relating to intellectual property rights acquired ($498.7 million), and tax effect of adjustments; |
b) | Acquisition and integration activities: Unwind of NPS inventory fair value adjustments ($29.8 million), unwind of ViroPharma inventory fair value adjustments ($1.3 million), acquisition and integration costs primarily associated with NPS, ViroPharma, Dyax and the announced combination with Baxalta ($189.7 million), net credit related to the change in the fair value of contingent consideration liabilities ($149.9 million), and tax effect of adjustments; |
c) | Divestments, reorganizations and discontinued operations: Net gain on re-measurement of DAYTRANA contingent consideration to fair value ($13.6 million), gain on disposal of non-core product rights ($1.1 million), costs relating to the One Shire reorganization, primarily costs relating to the relocation of staff from Chesterbrook to Lexington ($97.9 million), gain on sale of long term investments ($14.1 million), tax effect of adjustments and loss from discontinued operations, net of tax ($34.1 million); |
d) | Legal and litigation costs: Costs related to litigation, government investigations, other disputes and external legal costs ($9.5 million), and tax effect of adjustments; |
e) | Other: Costs associated with AbbVie’s terminated offer for Shire ($60.1 million), interest income received in respect of cash deposited with the Canadian revenue authorities ($1.1 million); and |
f) | Depreciation reclassification: Depreciation of $138.5 million included in Cost of product sales, R&D and SG&A for US GAAP separately disclosed for the presentation of Non GAAP earnings. |
![]() | 24 |
Unaudited results for the year to December 31, 2014
Non GAAP reconciliation
Year to December 31, 2014 | US GAAP | Adjustments | Non GAAP | |||||||
(a) | (b) | (c) | (d) | (e) | (f) | |||||
$M | $M | $M | $M | $M | $M | $M | $M | |||
Total revenues | 6,022.1 | - | - | - | - | - | - | 6,022.1 | ||
Costs and expenses: | ||||||||||
Cost of product sales | 979.3 | - | (91.9) | - | - | - | (57.1) | 830.3 | ||
R&D | 1,067.5 | (190.3) | (12.5) | - | - | - | (24.5) | 840.2 | ||
SG&A | 2,025.8 | (243.8) | - | - | (9.2) | (95.8) | (81.9) | 1,595.1 | ||
Gain on sale of product rights | (88.2) | - | - | 88.2 | - | - | - | - | ||
Reorganization costs | 180.9 | - | - | (180.9) | - | - | - | - | ||
Integration and acquisition costs | 158.8 | - | (158.8) | - | - | - | - | - | ||
Depreciation | - | - | - | - | - | - | 163.5 | 163.5 | ||
Total operating expenses | 4,324.1 | (434.1) | (263.2) | (92.7) | (9.2) | (95.8) | - | 3,429.1 | ||
Operating income | 1,698.0 | 434.1 | 263.2 | 92.7 | 9.2 | 95.8 | - | 2,593.0 | ||
Interest income | 24.7 | - | - | - | - | (22.0) | - | 2.7 | ||
Interest expense | (30.8) | - | - | - | - | - | - | (30.8) | ||
Other income/(expense), net | 8.9 | - | (4.7) | (15.8) | - | - | - | (11.6) | ||
Receipt of break fee | 1,635.4 | - | - | - | - | (1,635.4) | - | - | ||
Income before income taxes and equity in earnings of equity method investees | 3,336.2 | 434.1 | 258.5 | 76.9 | 9.2 | (1,561.6) | - | 2,553.3 | ||
Income taxes | (56.1) | (126.7) | (24.1) | (22.2) | (3.4) | (235.0) | - | (467.5) | ||
Equity in earnings of equity method investees, net of tax | 2.7 | - | - | - | - | - | - | 2.7 | ||
Income from continuing operations | 3,282.8 | 307.4 | 234.4 | 54.7 | 5.8 | (1,796.6) | - | 2,088.5 | ||
Gain from discontinued operations, net of tax | 122.7 | - | - | (122.7) | - | - | - | - | ||
Net income | 3,405.5 | 307.4 | 234.4 | (68.0) | 5.8 | (1,796.6) | - | 2,088.5 | ||
Weighted average number of shares (millions) – diluted | 591.3 | - | - | - | - | - | - | 591.3 | ||
Diluted earnings per ADS | 1,728.0c | 155.9c | 118.7c | (34.6c) | 3.0c | (911.4c) | - | 1,059.6c |
The following items are included in Adjustments:
a) | Amortization and asset impairments: Impairment of IPR&D intangible assets ($190.3 million), amortization of intangible assets relating to intellectual property rights acquired ($243.8 million), and tax effect of adjustments; |
b) | Acquisition and integration activities: Unwind of ViroPharma inventory fair value adjustments ($91.9 million), payments in respect of in-licensed and acquired products ($12.5 million), costs primarily associated with the acquisition and integration of ViroPharma ($144.1 million), net charge related to the change in fair values of contingent consideration liabilities ($14.7 million), gain on settlement of pre-existing relationship with an acquired business ($4.7 million), and tax effect of adjustments; |
c) | Divestments, reorganizations and discontinued operations: Net gain on divestment of non-core product rights and on re-measurement of DAYTRANA contingent consideration to fair value ($88.2 million), costs relating to the One Shire reorganization ($180.9 million), gain on sale of long term investments ($15.8 million), tax effect of adjustments and gain from discontinued operations, net of tax ($122.7 million); |
d) | Legal and litigation costs: Costs related to litigation, government investigations, other disputes and external legal costs ($9.2 million), and tax effect of adjustments; |
e) | Other: Costs associated with AbbVie’s terminated offer for Shire ($95.8 million), interest income received in respect of cash deposited with the Canadian revenue authorities ($22.0 million), receipt of break fee from AbbVie ($1,635.4 million), net income tax credit related to the settlement of certain tax positions with the Canadian revenue authorities ($235.0 million), and tax effect of adjustments; and |
f) | Depreciation reclassification: Depreciation of $163.5 million included in Cost of product sales, R&D and SG&A for US GAAP separately disclosed for the presentation of Non GAAP earnings. |
![]() | 25 |
Unaudited results for the three months to December 31, 2015
Non GAAP reconciliation
3 months to December 31, 2015 | US GAAP | Adjustments | Non GAAP | |||||||
(a) | (b) | (c) | (d) | (e) | (f) | |||||
$M | $M | $M | $M | $M | $M | $M | $M | |||
Total revenues | 1,715.7 | - | - | - | - | - | - | 1,715.7 | ||
Costs and expenses: | ||||||||||
Cost of product sales | 250.5 | - | (8.1) | - | - | (0.6) | (11.7) | 230.1 | ||
R&D | 353.2 | (120.4) | - | - | - | (1.0) | (4.5) | 227.3 | ||
SG&A | 632.3 | (146.4) | - | - | (5.1) | (2.5) | (17.2) | 461.1 | ||
Gain on sale of product rights | (1.7) | - | - | 1.7 | - | - | - | - | ||
Reorganization costs | 38.3 | - | - | (38.3) | - | - | - | - | ||
Integration and acquisition costs | 86.6 | - | (86.6) | - | - | - | - | - | ||
Depreciation | - | - | - | - | - | - | 33.4 | 33.4 | ||
Total operating expenses | 1,359.2 | (266.8) | (94.7) | (36.6) | (5.1) | (4.1) | - | 951.9 | ||
Operating income | 356.5 | 266.8 | 94.7 | 36.6 | 5.1 | 4.1 | - | 763.8 | ||
Interest income | 0.8 | - | - | - | - | - | - | 0.8 | ||
Interest expense | (10.0) | - | - | - | - | - | - | (10.0) | ||
Other expense, net | (8.2) | - | - | - | - | - | - | (8.2) | ||
Income before income taxes and equity in losses of equity method investees | 339.1 | 266.8 | 94.7 | 36.6 | 5.1 | 4.1 | - | 746.4 | ||
Income taxes | (55.1) | (70.5) | (14.8) | (12.5) | (1.9) | (3.4) | - | (158.2) | ||
Equity in losses of equity method investees, net of tax | (0.6) | - | - | - | - | - | - | (0.6) | ||
Income from continuing operations | 283.4 | 196.3 | 79.9 | 24.1 | 3.2 | 0.7 | - | 587.6 | ||
Loss from discontinued operations, net of tax | (2.8) | - | - | 2.8 | - | - | - | - | ||
Net income | 280.6 | 196.3 | 79.9 | 26.9 | 3.2 | 0.7 | - | 587.6 | ||
Weighted average number of shares (millions) – diluted | 593.3 | - | - | - | - | - | - | 593.3 | ||
Diluted earnings per ADS | 141.9c | 99.3c | 40.5c | 13.5c | 1.5c | 0.3c | - | 297.1c |
The following items are included in Adjustments:
(a) | Amortization and asset impairments: Impairment of SHP625 IPR&D intangible asset ($120.4 million), amortization of intangible assets relating to intellectual property rights acquired ($146.4 million), and tax effect of adjustments; |
(b) | Acquisition and integration activities: Unwind of NPS inventory fair value adjustments ($8.1 million), acquisition and integration costs primarily associated with NPS, ViroPharma, Dyax and the announced combination with Baxalta ($40.0 million), charges related to the change in fair value of contingent consideration liabilities ($46.6 million), and tax effect of adjustments; |
(c) | Divestments, reorganizations and discontinued operations: Gain on re-measurement of DAYTRANA contingent consideration to fair value ($1.7 million), costs relating to the One Shire reorganization, primarily costs relating to the relocation of staff from Chesterbrook to Lexington ($38.3 million), tax effect of adjustments, and loss from discontinued operations, net of tax ($2.8 million); |
(d) | Legal and litigation costs: Costs related to litigation, government investigations, other disputes and external legal costs ($5.1 million), and tax effect of adjustments; |
(e) | Other: Costs associated with AbbVie’s terminated offer for Shire ($4.1 million), and tax effect of adjustments; and |
(f) | Depreciation reclassification: Depreciation of $33.4 million included in Cost of product sales, R&D and SG&A for US GAAP separately disclosed for the presentation of Non GAAP earnings. |
![]() | 26 |
Unaudited results for the three months to December 31, 2014
Non GAAP reconciliation
3 months to December 31, 2014 | US GAAP | Adjustments | Non GAAP | |||||||
(a) | (b) | (c) | (d) | (e) | (f) | |||||
$M | $M | $M | $M | $M | $M | $M | $M | |||
Total revenues | 1,576.1 | - | - | - | - | - | - | 1,576.1 | ||
Costs and expenses: | ||||||||||
Cost of product sales | 218.5 | - | (1.3) | - | - | - | (12.2) | 205.0 | ||
R&D | 241.5 | (2.3) | - | - | - | - | (6.8) | 232.4 | ||
SG&A | 576.4 | (61.9) | - | - | (2.0) | (48.3) | (19.3) | 444.9 | ||
Gain on sale of product rights | (2.0) | - | - | 2.0 | - | - | - | - | ||
Reorganization costs | 57.5 | - | - | (57.5) | - | - | - | - | ||
Integration and acquisition costs | 3.0 | - | (3.0) | - | - | - | - | - | ||
Depreciation | - | - | - | - | - | - | 38.3 | 38.3 | ||
Total operating expenses | 1,094.9 | (64.2) | (4.3) | (55.5) | (2.0) | (48.3) | - | 920.6 | ||
Operating income | 481.2 | 64.2 | 4.3 | 55.5 | 2.0 | 48.3 | - | 655.5 | ||
Interest income | 1.9 | - | - | - | - | (0.6) | - | 1.3 | ||
Interest expense | (5.1) | - | - | - | - | - | - | (5.1) | ||
Other expense, net | (5.9) | - | - | - | - | - | - | (5.9) | ||
Receipt of break fee | 1,635.4 | - | - | - | - | (1,635.4) | - | - | ||
Income before income taxes and equity in losses of equity method investees | 2,107.5 | 64.2 | 4.3 | 55.5 | 2.0 | (1,587.7) | - | 645.8 | ||
Income taxes | (120.8) | (21.2) | 19.3 | (10.7) | (0.8) | 8.7 | - | (125.5) | ||
Equity in losses of equity method investees, net of tax | (1.1) | - | - | - | - | - | - | (1.1) | ||
Income from continuing operations | 1,985.6 | 43.0 | 23.6 | 44.8 | 1.2 | (1,579.0) | - | 519.2 | ||
Gain from discontinued operations, net of tax | 186.7 | - | - | (186.7) | - | - | - | - | ||
Net income | 2,172.3 | 43.0 | 23.6 | (141.9) | 1.2 | (1,579.0) | - | 519.2 | ||
Weighted average number of shares (millions) – diluted | 591.4 | - | - | - | - | - | - | 591.4 | ||
Diluted earnings per ADS | 1,101.9c | 21.9c | 12.0c | (72.0c) | 0.6c | (801.0c) | - | 263.4c |
The following items are included in Adjustments:
(a) | Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($61.9 million), impairment of IPR&D intangible assets ($2.3 million), and tax effect of adjustments; |
(b) | Acquisition and integration activities: Unwind of ViroPharma inventory fair value adjustments ($1.3 million), costs primarily associated with the acquisition and integration of ViroPharma ($14.6 million), net credit related to the change in fair value of contingent consideration liabilities ($11.6 million), and tax effect of adjustments; |
(c) | Divestments, reorganizations and discontinued operations: Net gain on divestment of non-core product rights and on re-measurement of DAYTRANA contingent consideration to fair value ($2.0 million), costs relating to the One Shire reorganization ($57.5 million), tax effect of adjustments, and gain from discontinued operations, net of tax ($186.7 million); |
(d) | Legal and litigation costs: Costs related to litigation, government investigations, other disputes and external legal costs ($2.0 million), and tax effect of adjustments; |
(e) | Other: Costs associated with AbbVie’s terminated offer for Shire ($48.3 million), interest income received in respect of cash deposited with the Canadian revenue authorities ($0.6 million), receipt of break fee from AbbVie ($1,635.4 million), net income tax credit related to the settlement of certain tax positions with the Canadian revenue authorities ($8.7 million), and tax effect of adjustments; and |
(f) | Depreciation reclassification: Depreciation of $38.3 million included in Cost of product sales, R&D and SG&A for US GAAP separately disclosed for the presentation of Non GAAP earnings. |
![]() | 27 |
Unaudited results for the three months and year to December 31, 2015 and 2014
Non GAAP reconciliation
The following table reconciles US GAAP net income to Non GAAP EBITDA:
3 months to December 31, | Year to December 31, | |||||||
2015 | 2014 | 2015 | 2014 | |||||
$M | $M | $M | $M | |||||
US GAAP Net Income | 280.6 | 2,172.3 | 1,303.4 | 3,405.5 | ||||
(Deduct)/add back: | ||||||||
Loss/(gain) from discontinued operations, net of tax | 2.8 | (186.7) | 34.1 | (122.7) | ||||
Equity in losses/(earnings) of equity method investees, net of taxes | 0.6 | 1.1 | 2.2 | (2.7) | ||||
Income taxes | 55.1 | 120.8 | 46.1 | 56.1 | ||||
Other income/(expense), net | 8.2 | 5.9 | (3.7) | (8.9) | ||||
Receipt of break fee | - | (1,635.4) | - | (1,635.4) | ||||
Interest expense | 10.0 | 5.1 | 41.6 | 30.8 | ||||
Interest income | (0.8) | (1.9) | (4.2) | (24.7) | ||||
US GAAP Operating income from continuing operations | 356.5 | 481.2 | 1,419.5 | 1,698.0 | ||||
Amortization | 146.4 | 61.9 | 498.7 | 243.8 | ||||
Depreciation | 33.4 | 38.3 | 138.5 | 163.5 | ||||
Asset impairments | 120.4 | 2.3 | 643.7 | 190.3 | ||||
Acquisition and integration activities | 94.7 | 4.3 | 70.9 | 263.2 | ||||
Divestments, reorganizations and discontinued operations | 36.6 | 55.5 | 83.2 | 92.7 | ||||
Legal and litigation costs | 5.1 | 2.0 | 9.5 | 9.2 | ||||
Other | 4.1 | 48.3 | 60.1 | 95.8 | ||||
Non GAAP EBITDA | 797.2 | 693.8 | 2,924.1 | 2,756.5 | ||||
Depreciation | (33.4) | (38.3) | (138.5) | (163.5) | ||||
Non GAAP Operating income from continuing operations | 763.8 | 655.5 | 2,785.6 | 2,593.0 | ||||
Net income margin(1) | 16% | 138% | 20% | 57% | ||||
Non GAAP EBITDA margin(2) | 43% | 41% | 43% | 44% | ||||
(1) Net income as a percentage of total revenues. | ||||||||
(2) Non GAAP EBITDA as a percentage of product sales, excluding royalties and other revenues. |
![]() | 28 |
Unaudited results for the three months and year to December 31, 2015 and 2014
Non GAAP reconciliation
The following table reconciles US GAAP product sales to Non GAAP Gross Margin:
3 months to December 31, | Year to December 31, | |||||||
2015 | 2014 | 2015 | 2014 | |||||
$M | $M | $M | $M | |||||
US GAAP Product Sales | 1,623.7 | 1,500.7 | 6,099.9 | 5,830.4 | ||||
(Deduct)/add back: | ||||||||
Cost of product sales (US GAAP) | (250.5) | (218.5) | (969.0) | (979.3) | ||||
Unwind of inventory fair value step-up | 8.1 | 1.3 | 31.1 | 91.9 | ||||
Costs of employee retention awards following AbbVie's terminated offer for Shire | 0.6 | - | 7.1 | - | ||||
Depreciation | 11.7 | 12.2 | 46.1 | 57.1 | ||||
Non GAAP Gross Margin | 1,393.6 | 1,295.7 | 5,215.2 | 5,000.1 | ||||
Non GAAP Gross Margin % (1) | 85.8% | 86.3% | 85.5% | 85.8% | ||||
(1) Gross Product Margin as a percentage of product sales. |
The following table reconciles US GAAP net cash provided by operating activities to Non GAAP cash generation:
3 months to December 31, | Year to December 31, | ||||||
2015 | 2014 | 2015 | 2014 | ||||
$M | $M | $M | $M | ||||
Net cash provided by operating activities | 761.8 | 2,554.9 | 2,337.0 | 4,228.4 | |||
Tax and interest payments, net | 51.6 | 49.3 | 85.2 | 213.0 | |||
Receipt from the Canadian revenue authorities | - | (169.0) | - | (417.0) | |||
Up-front payments in respect of in-licensed and acquired products | - | - | - | 12.5 | |||
Receipt of break fee | - | (1,635.4) | - | (1,635.4) | |||
Non GAAP cash generation | 813.4 | 799.8 | 2,422.2 | 2,401.5 |
The following table reconciles US GAAP net cash provided by operating activities to Non GAAP free cash flow:
3 months to December 31, | Year to December 31, | ||||||
2015 | 2014 | 2015 | 2014 | ||||
$M | $M | $M | $M | ||||
Net cash provided by operating activities | 761.8 | 2,554.9 | 2,337.0 | 4,228.4 | |||
Up-front payments in respect of in-licensed and acquired products | - | - | - | 12.5 | |||
Capital expenditure | (52.6) | (27.2) | (114.7) | (77.0) | |||
Receipt of break fee | - | (1,635.4) | - | (1,635.4) | |||
Non GAAP free cash flow | 709.2 | 892.3 | 2,222.3 | 2,528.5 |
![]() | 29 |
Non GAAP net (debt)/cash comprises:
December 31, | December 31, | ||
2015 | 2014 | ||
$M | $M | ||
Cash and cash equivalents | 135.5 | 2,982.4 | |
Long term borrowings | (69.9) | - | |
Short term borrowings | (1,511.5) | (850.0) | |
Other debt | (13.4) | (13.7) | |
Non GAAP net (debt)/cash | (1,459.3) | 2,118.7 |
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
www.shire.com
![]() | 30 |
THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995(1)
Statements included herein that are not historical facts, including without limitation statements concerning our announced business combination with Baxalta and the timing and financial and strategic benefits thereof, 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 company’s 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, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
· | the proposed combination with Baxalta may not be completed due to a failure to satisfy certain closing conditions, including any shareholder or regulatory approvals or the receipt of applicable tax opinions; |
· | disruption from the proposed transaction with Baxalta may make it more difficult to conduct business as usual or maintain relationships with patients, physicians, employees or suppliers; |
· | the combined company may not achieve some or all of the anticipated benefits of Baxalta’s spin-off from Baxter International, Inc. (“Baxter”) and the proposed transaction may have an adverse impact on Baxalta’s 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 proposed combination with Baxalta may adversely affect the combined company’s 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 combined company’s 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 combined company’s ability to sell or market products profitably, and fluctuations in buying or distribution patterns by such customers can adversely affect the combined company’s revenues, financial condition or results of operations; |
· | investigations or enforcement action by regulatory authorities or law enforcement agencies relating to the combined company’s 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 and other disputes, including the combined company’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the combined company’s 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 combined company’s 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 Shire’s acquisition of NPS Pharmaceuticals Inc. or Dyax may adversely affect the combined company’s financial condition and results of operations; |
· | the combined company will be 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 combined company’s revenues, financial condition or results of operations; |
· | the combined company may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other business partners; |
(1) The safe harbors for forward-looking statements under the Private Securities Litigation Reform Act of 1995 are not applicable to forward-looking statements, if any, in connection with Shire’s tender offers for Dyax and Baxalta.
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· | difficulties in integrating Dyax or Baxalta into Shire may lead to the combined 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 Shire’s, Dyax’s or Baxalta’s filings with the Securities and Exchange Commission (“SEC”), including those risks outlined in Baxalta’s current Registration Statement on Form S-1, as amended, and in “ITEM 1A: Risk Factors” in Shire’s Annual Report on Form 10-K for the year ended December 31, 2014.
All foward-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.
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NON GAAP MEASURES
This press release contains financial measures not prepared in accordance with US GAAP. These measures are referred to as “Non GAAP” measures and include: Non GAAP operating income; Non GAAP net income; Non GAAP diluted earnings per ADS; effective tax rate on Non GAAP income before income taxes and earnings/(losses) of equity method investees (“effective tax rate on Non GAAP income”); Non GAAP cost of product sales; Non GAAP gross margin; Non GAAP R&D; Non GAAP SG&A; Non GAAP other income/(expense); Non GAAP interest income; Non GAAP cash generation; Non GAAP free cash flow, Non GAAP net cash/(debt), Non GAAP EBITDA and Non GAAP EBITDA margin (excluding royalties and other revenues)(1). These Non GAAP measures exclude the effect of certain cash and non-cash items that Shire's management believes are not related to the core performance of Shire’s business.
These Non GAAP financial measures are used by Shire’s management to make operating decisions because they facilitate internal comparisons of Shire’s performance to historical results and to competitors’ results. Shire’s Remuneration Committee uses certain key Non GAAP measures when assessing the performance and compensation of employees, including Shire’s directors.
The Non GAAP measures are presented in this press release as Shire’s management believe that they will provide investors with a means of evaluating, and an understanding of how Shire’s management evaluates, Shire’s performance and results on a comparable basis that is not otherwise apparent on a US GAAP basis, since many non-recurring, infrequent or non-cash items that Shire’s management believe are not indicative of the core performance of the business may not be excluded when preparing financial measures under US GAAP.
These Non GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with US GAAP.
Where applicable the following items, including their tax effect, have been excluded when calculating Non GAAP earnings for both 2015 and 2014, and from our Outlook:
Amortization and asset impairments:
· | Intangible asset amortization and impairment charges; and |
· | Other than temporary impairment of investments. |
Acquisitions and integration activities:
· | Up-front payments and milestones in respect of in-licensed and acquired products; |
· | Costs associated with acquisitions, including transaction costs, fair value adjustments on contingent consideration and acquired inventory; |
· | Costs associated with the integration of companies; and |
· | Noncontrolling interests in consolidated variable interest entities. |
Divestments, reorganizations and discontinued operations:
· | Gains and losses on the sale of non-core assets; |
· | Costs associated with restructuring and reorganization activities; |
· | Termination costs; and |
· | Income/(losses) from discontinued operations. |
Legal and litigation costs:
· | Net legal costs related to the settlement of litigation, government investigations and other disputes (excluding internal legal team costs). |
Other:
· | Net income tax credit (being income tax, interest and estimated penalties) related to the settlement of certain tax positions with the Canadian revenue authorities; |
· | Costs associated with AbbVie’s terminated offer for Shire, including costs of employee retention awards; and |
· | Break fee received in relation to AbbVie’s terminated offer for Shire. |
Depreciation, which is included in Cost of product sales, R&D and SG&A costs in our US GAAP results, has been separately disclosed for the presentation of 2015 and 2014 Non GAAP earnings.
__________________________
(1) Non GAAP EBITDA (as calculated on page 28 of this announcement) as a percentage of product sales, excluding royalties and other revenues.
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Cash generation represents net cash provided by operating activities, excluding up-front and milestone payments for in-licensed and acquired products, tax and interest payments. In 2014 the receipt of the break fee in relation to AbbVie’s terminated offer for Shire was excluded from cash generation.
Free cash flow represents net cash provided by operating activities, excluding up-front and milestone payments for in-licensed and acquired products, but including capital expenditure in the ordinary course of business. In 2014 the receipt of the break fee in relation to AbbVie’s terminated offer for Shire was excluded from free cash flow.
A reconciliation of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented on pages 24 to 30.
Growth at CER, which is a Non GAAP measure, is computed by restating 2015 results using average 2014 foreign exchange rates for the relevant period.
Average exchange rates used by Shire for the year to December 31, 2015 were $1.53:£1.00 and $1.11:€1.00 (2014: $1.65:£1.00 and $1.33:€1.00). Average exchange rates used by Shire for Q4 2015 were $1.52:£1.00 and $1.09:€1.00 (2014: $1.60:£1.00 and $1.25:€1.00).
TRADE MARKS
All trade marks designated ® and ™ used in this press release are trade marks of Shire plc or companies within the Shire group except for 3TC® and ZEFFIX® which are trade marks of GlaxoSmithKline, PENTASA® which is a trade mark of FERRING B.V. Corp, LIALDA® which is a trade mark of Nogra International Limited, MEZAVANT® which is a trade mark of Guiliani International Limited, CALCICHEW® which is a trade mark of Takeda and DAYTRANA® which is a trade mark of Noven Pharmaceutical Inc. Certain trade marks of Shire plc or companies within the Shire group are set out in Shire’s most recent Annual Report on Form 10-K for the year ended December 31, 2014.
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Exhibit 99.2
Creating the global leader in Rare Diseases Fourth quarter and full year results to December 31, 2015 4 Flemming Ornskov, M.D. CEO Jeff Poulton CFO Phil Vickers, Ph.D. Head of R&D February 11, 2016
2 “SAFE HARBOR” Statement Under the Private Securities Litigation Reform Act of 1995 Forward - Looking Statements Statements included herein that are not historical facts, including without limitation statements concerning our proposed bus ine ss combination with Baxalta Incorporated (“ Baxalta ”) and the timing and financial and strategic benefits thereof, our 20x20 ambition that targets $20 billion in combined product sales by 2020, as well as other t arg ets for future financial results, capital structure, performance and sustainability of the combined company, the combined company’s future strategy, plans, objectives, expectations and intentions, the anticipated tim ing 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 sub ject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following: • the proposed combination with Baxalta may not be completed due to a failure to satisfy certain closing conditions, including any shareholder or regulatory approval s or the receipt of applicable tax opinions; • disruption from the proposed transaction with Baxalta may make it more difficult to conduct business as usual or maintain relationships with patients, physicians, employees or sup pl iers; • the combined company may not achieve some or all of the anticipated benefits of Baxalta’s spin - off from Baxter International, Inc. (“Baxter”) and the proposed transaction may have an adverse impact on Baxalta’s 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 proposed combination with Baxalta may adversely affect the combined company’s 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 fo r the combined company’s 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 compe tit ors; 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, lo st 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 ex penditures and time, and there is no guarantee that these products will receive regulatory approval; • the actions of certain customers could affect the combined company’s ability to sell or market products profitably, and fluctuati ons in buying or distribution patterns by such customers can adversely affect the combined company’s revenues, financial condition or results of operations; • investigations or enforcement action by regulatory authorities or law enforcement agencies relating to the combined company’s 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 and other disputes, including the combined company’s ability to enforce and defend patents and othe r i ntellectual property rights required for its business, could have a material adverse effect on the combined company’s 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 uncer tai nty could adversely affect the combined company’s 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 Shire’s acquisition of NPS Pharmaceuticals Inc. or Dyax Corp. (“ Dyax ”) may adversely affect the combined company’s financial condition and results of operations; • the combined company will be dependent on information technology and its systems and infrastructure face certain risks, including fr om 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 combined company’s revenues, fi nan cial condition or results of operations; • the combined company may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers a nd other business partners; • difficulties in integrating Dyax or Baxalta into Shire may lead to the combined company not being able to realize the expected operating efficiencies, cost savings, reve nu e enhancements, synergies or other benefits at the time anticipated or at all; and other risks and uncertainties detailed from time to time in Shire’s, Dyax’s or Baxalta’s filings with the Securities and Exchange Commission (“SEC”), including those risks outlined in Baxalta’s current Registration Statement on Form S - 1, as amended, and in “Item 1A: Risk Factors” in Shire’s Annual Report on Form 10 - K for the year ended Decem ber 31, 2014. All forward - looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety b y 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.
3 “SAFE HARBOR” Statement Under the Private Securities Litigation Reform Act of 1995 (continued) Additional Information This communication does not constitute an offer to buy or solicitation of any offer to sell securities or a solicitation of a ny vote or approval. It does not constitute a prospectus or prospectus equivalent document. This communication relates to the proposed business combination between Shire and Baxalta . The proposed combination will be submitted to Shire’s and Baxalta’s shareholders for their consideration and approval. In connection with the proposed combination, Shire and Baxalta will file relevant materials with ( i ) the SEC, including a Shire registration statement on Form S - 4 that will include a proxy statement of Baxalta and a prospectus of Shire, and (ii) the Financial Conduct Authority (FCA) in the UK, including a prospectus relating to Shire ordinary shares to be issued i n c onnection with the proposed combination and a circular to the shareholders of Shire. Baxalta will mail the proxy statement/prospectus to its shareholders and Shire will mail the circular to its shareholders. This communicat ion is not a substitute for the registration statement, proxy statement/prospectus, UK prospectus, circular or other document(s) that Shire and/or Baxalta may file with the SEC or the FCA in connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS OF SHIRE AND BAX AL TA ARE URGED TO READ CAREFULLY THE REGISTRATION STATEMENT,PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS FILED WITH THE SEC AND THE UK PROSPE CTU S AND CIRCULAR WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SHIRE, BAXALTA AND THE PROPOSED TRANSACTION. Investors and se cur ity holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SEC’s web site at www.sec.gov. Investors may req uest copies of the documents filed with the SEC by Shire by directing a request to Shire’s Investor Relations department at Shire plc, Attention: Investor Relations, 300 Shire Way, Lexington, MA 02421 or to Shire’s I nve stor Relations department at +1 484 595 2220 in the U.S. and +44 1256 894157 in the UK or by email to investorrelations@shire.com. Investors may request copies of the documents filed with the SEC by Baxalta by directing a request to Mary Kay Ladone at mary.kayklandone@baxalta.com or (224) 948 - 3371. The statements in this presentation are Shire’s statements and not those of Baxalta or any third party. Certain Information Regarding Participants Shire, Baxalta and their respective directors and executive officers may be deemed participants in the solicitation of proxies in connection w ith the proposed transaction. You can find information about Shire’s directors and executive officers in Shire’s Annual Report on Form 10 - K for the year ended December 31, 2014, which was filed with the SEC on F ebruary 24, 2015. You can find information about Baxalta’s directors and executive officers in Baxalta’s registration statement on Form S - 1, which was filed with the SEC on September 1, 2015.Additional information regarding the spec ial interests of these directors and executive officers in the proposed transaction will be included in the registration statement, proxy statement/prospectus or other documents filed with the SEC if any when the y become available. You may obtain these documents (when they become available) free of charge at the SEC’s web site at www.sec.gov and from Investor Relations at Shire or Baxalta as described above. This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall the re be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be ma de except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended. Trademarks Shire owns or has rights to use the trademarks, service marks and trade names that it uses in conjunction with the operation of its bu siness. Some of the trademarks that Shire owns or has the rights to use that are referenced in this communication include: ADDERALL XR, CINRYZE, ELAPRASE, FIRAZYR, GATTEX/REVESTIVE, INTUNIV, LIALDA, NATPARA , R EPLAGAL, PENTASA, VPRIV, VYVANSE and XAGRID. Baxalta states that it owns or has the right to use certain trademarks referenced in this communication, including: ADVATE, ADYNOVATE, ARALA ST, FEIBA, FLEXBUMIN, GAMMAGARD, GAMMAGARD LIQUID, GLASSIA, HYQVIA, OBIZUR, ONCASPAR, ONIVYDE, RECOMBINATE, RIXUBIS and SUBCUVIA, which may be registered or used in the United States and other jur isdictions. Basis of Forecasts The Shire forecasts included herein are derived from Shire’s Long Range Plan (the "LRP") and Shire papers subsequently produced a s p art of the business planning process. Shire produces a long range plan annually. The LRP was updated in March 2015, as part of Shire’s annual planning cycle, and was reviewed by the Board in April 2015. This L RP was subsequently adjusted to reflect revised expectations for SHP625 following trial results in the second quarter of 2015, the Dyax acquisition and other updates for 2015 actual performance. The forecast product sales in Shire’s January 11, 2016 announcement on the proposed combination with Baxalta are consistent with the LRP, which is at constant exchange rates, and reflects net sales for each product and key line extensions currently identified as in Phase III, Phase II and those in Phase I included in the LRP as launching befo re the end of 2020. The forecast product sales included in the LRP are risk - adjusted to reflect Shire’s assessment of the individual probability of launch of products in development, and the probability of success in further life cycle management trials. Estimates for these probabilities are based on industry wide data for relevant clinical trials in the pharmaceutical in dustry at a similar stage of development. For each pharmaceutical product, there is a range of possible outcomes from clinical development, driven by a number of varia ble s, including safety, efficacy and product labelling. In addition, if a product is approved, the effect of commercial factors including the patient population, the competitive environment, pricing and reimbursement is also un certain. As a result, the actual net sales achieved by a product over its commercial life will be different, perhaps materially so, from the risk adjusted net sales figures in this announcement and should be considered in t his light. The forecast product sales for Baxalta’s included in this communication have been stated on a constant currency and risk adjusted basis . IMS information is an estimate derived from the use of information under license from the following IMS Health information servic e: IMS NPA Weekly for the period Jan 17, 2014 to Jan 22, 2016. IMS expressly reserves all rights, including rights of copying, distribution and republication .
4 Agenda Creating the global leader in Rare Diseases Financial review Summary Q & A Flemming Ornskov , M.D. Progressing our innovative pipeline Phil Vickers, Ph.D Jeff Poulton Flemming Ornskov, M.D. All
5 2013 - 2015 Becoming OneShire Step - change in performance Effective and efficient organization Established foundation for long - term growth Investing to create further long - term value 2013 2014 2015 2016 2017 2018 2019 2020+ Our continuous transformation 2014 - 2016 Building a leading global biotech company Creating scale and momentum Culture of bold innovation – internal and external Patient - centric Rare Diseases mindset 2016+ Global Leadership in Rare Diseases Multiple, durable, best - in - class products Compelling financial profile Enhanced diversification and optionality
6 2015 & recent achievements: significant steps towards advancing our strategy • Closed NPS Pharma acquisition adding two new rare disease assets in GATTEX/ REVESTIVE and NATPARA/NATPAR • Reported positive results from the OPUS - 3 study • Resubmitted NDA on January 22, 2016 for treatment of signs and symptoms of Dry Eye Disease • FDA acceptance of NDA and July 22, 2016 PDUFA date Lifitegrast for adults with D ry E ye D isease • Announced combination with Baxalta , which would create the global leader in Rare Diseases • Closed Dyax Corp acquisition • SHP643 (DX2930) expands and extends Shire’s leading Hereditary Angioedema (HAE) portfolio
7 Strong performance driven by VYVANSE, LIALDA/MEZAVANT, CINRYZE, FIRAZYR, and the inclusion of GATTEX/REVESTIVE and NATPARA NPS assets continue to benefit from Shire’s GI and Rare Disease expertise GROWTH Double - digit CER (1)(4) product sales growth excluding INTUNIV in FY 2015 INNOVATION Double - digit Non GAAP diluted earnings per ADS (2) (4 ) growth in FY 2015 (1) Constant exchange rates (“CER”), a Non GAAP financial measure. CER performance is determined by comparing 2015 performance (restated using 2014 exchange rates) to actual 2014 reported performance. (2) This is a Non GAAP financial measure. The most directly comparable measure under U.S. GAAP is EPS - ADS (FY 2015: $6.59, FY 2014: $17.2 8). (3) Subject to regulatory approval. (4) See slide 39 for a list of items excluded from the U.S. GAAP equivalent used to calculate all Non GAAP measures detailed abov e. A reconciliation of Non GAAP financial measures to the most directly comparable measure under U.S. GAAP is presented in Shire's Q4 2015 earnings release o n p ages 24 to 30 . SHP621 for eosinophilic esophagitis PDUFA date for lifitegrast of July 22, 2016; launch anticipated Q3 2016 (3) Closed Dyax acquisition, reinforcing Shire’s leadership in HAE Announced combination with Baxalta , which would create a global biotechnology company with leadership in Rare Diseases CINRYZE for AMR CINRYZE subcutaneous (SC) for HAE Completed Phase 3 enrollment of SHP465 ahead of schedule; results expected H1:16 Completed Phase 2 enrollment of SHP607 for retinopathy of prematurity; results expected mid - 2016 I nitiated three Phase 3 studies : 2015: Recent & full - year highlights
8 Delivering robust top and bottom line growth while investing in the future $5,830m +$787m $6,100m • Core product sales excluding INTUNIV growing 14% on a CER basis (1)(2)(6) • Continued investment in new product launches and delivery of a 43% Non GAAP EBITDA margin (3)(4)(6) • FY 2015 Non GAAP diluted earnings per ADS (5)(6) up 10% on a reported basis; 14% on a CER basis (2)(6) - $260m - $257m FY 2014 Core products (1) INTUNIV FX FY 2015 GROWTH - 5% - 4% Product Sales (1) Results include NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015). Core product sales exclude INTUNIV and are stated at constant exchange rate (“CER”). (2) CER is a Non GAAP financial measure. CER performance is determined by comparing 2015 performance (restated using average 2014 foreign exchange rates for the relevant per iod) to actual 2014 reported performance . (3) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Income margin (FY 2015: 20%, FY 2014: 57%). (4) Non GAAP earnings before interest, tax, depreciation and amortization (“EBITDA ”) as a percentage of product sales, excluding Royalties and Other Revenues. (5) This is a Non GAAP financial measure. The most directly comparable measure under U.S. GAAP is EPS - ADS (FY 2015 : $6.59, FY 2014: $17.28). (6) See slide 39 for a list of items excluded from the U.S. GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconciliation of non - GAAP financial measures to the most directly comparable measure under U.S. GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. GROWTH +14% Double - digit Non GAAP diluted earnings per ADS growth exceeded guidance
9 Multiple drivers of robust topline growth GROWTH (1) Growth rates are at Constant exchange rates (“CER”), a Non GAAP financial measure. CER performance is determined by comparing 20 15 performance (restated using 2014 exchange rates for the relevant period) to actual 2014 reported performance. See slide 39 for a list of items excluded from the U.S. GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconciliation of Non GAAP financial measures to th e most directly comparable measure under U.S. GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. (2) GATTEX refers to pro - forma growth including product sales recorded by NPS prior to acquisition by Shire on a CER basis . (3) Patients on therapy include those on commercial supply, patient assistance, and compassionate - use programs CINRYZE sales $618M ; +24% ( 1) • Sales growth driven primarily by an increase in the number of new physicians prescribing for the first time, driving more patients on therapy, combined with a modest price increase • Strengthened our manufacturing position through renegotiation of agreement with Sanquin ; Shire now in a position to seek a second source of supply FIRAZYR sales $445M ; + 25% ( 1) • Continued double digit growth primarily driven by new patient additions • Sales also benefitted from a price increase taken since Q3 2014 LIALDA sales $684M; +10% ( 1 ) • U.S. prescription growth of 10% • Market share gains driven by consistent messaging from highly specialized salesforce • Improved access to physicians as we increase awareness of GATTEX with gastroenterologists VYVANSE sales $1,722M ; + 21% ( 1) • Vyvanse performing strongly, particularly in the adult market which includes both ADHD and BED • U.S. growth driven by volume gains ( TRx up 8% YoY ), price, and favorable stocking patterns • International growth continues to benefit from gains in established markets • VYVANSE patents held to be valid and infringed on appeal; patents expire in 2023 GATTEX sales $142M ; + 53% ( 2) • Strong performance since NPS acquisition; 639 patients on therapy worldwide as of 12/31/15 (3) • Leveraging LIALDA salesforce to aid patient identification • International roll out on track; favorable reimbursement obtained in France and Germany, launched in Nordics and Canada, encouraging early reception from patients and physicians NATPARA sales $24M • Strong U.S. launch in April 2015 • 695 patients on therapy worldwide as of 12/31/15 (3)
10 Vyvanse above - market performance driven by uptake in the adult ADHD market and in adults with Binge - Eating Disorder since launch in Q1:15 Year - to - date 2016 weekly TRx volume Vyvanse growth of 16.8% versus 9.9% for adult ADHD market Outperformance of Vyvanse continues Rolling 4 - week YoY adult TRx growth 12.3% 10.1% 11.2% 9.9% 19.2% 17.2% 19.6% 16.8% 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 2 4 ADHD VYVANSE Week Vyvanse BED launch 2016 Source : This information is an estimate derived from the use of information under license from the following IMS Health information service: IMS NPA Weekly for the period Jan 17, 2014 to Jan 22, 2016 . IMS expressly reserves all rights, including rights of copying, distribution and republication .
11 Source: Shire (1) Year - over - year change in U.S. patient start forms from 2013 to 2014 (2) Year - over - year change in U.S. patient start forms from 2014 to 2015 (3) Includes patients on commercial supply and patient assistance programs U.S. patient start forms 2015 467 2014 420 GATTEX; growth in patient start forms, treated patients continues to rise Shire acquires NPS Q1:15 and combines GATTEX/LIALDA sales team efforts in Q3:15 to drive disease awareness and patient identification Physicians/patients becoming more experienced in managing SBS and using GATTEX U.S. patients on therapy (3) - 19% (1) +11% (2) Gattex / Lialda combined sales efforts 0 100 200 300 400 500 600 Q1/14 Q2/14 Q3/14 Q4/14 Q1/15 Q2/15 Q3/15 Q4/15
12 NATPARA; treated patients increasing 9 months post launch Shire capabilities • 55 experienced, dedicated Rare Disease sales specialists/ managers • Shire OnePath patient services support including field - based Patient Access Managers support every patient • Access team; enabled coverage of >80% commercial lives in first 9 months of launch 196 419 694 Q2 2015 Q3 2015 Q4 2015 Source: Shire (1 ) Includes patients on commercial supply and patient assistance programs U.S. NATPARA patients on therapy (1)
Our purpose We enable people with life - altering conditions to lead better lives. Phil Vickers, Head of R&D Progressing Shire’s Innovative Pipeline
14 R&D Pipeline most robust in Shire’s history Preclinical Phase 1 Phase 2 Phase 3 Registration TH / GCH1 GenePod Parkinson’s Subset 27 Research Programs SHP627 Focal Segmental Glomerulosclerosis SHP608 Dystrophic E.Bullosa (clinical hold ) SHP631 Hunter Syndrome SHP616 (CINRYZE SC) HAE Prophylaxis SHP623 (rC1 - INH) HAE prophylaxis SHP626 Non - Alcoholic Steatohepatitis SHP622 Friedreich’s Ataxia SHP616 ( CINRYZE)* Acute Neuromyelitis Optica (Ph2/3) SHP610 Sanfilippo A LDX (Japan) ADHD (Ph2/3) SHP607 Prevention of ROP SHP625 Progressive Familial Intrahepatic Cholestasis SHP625 Alagille Syndrome SHP616 (CINRYZE) Acute Antibody Mediated Rejection SHP625 Primary Sclerosing Cholangitis SHP625 Primary Biliary Cirrhosis SHP621 (Former Meritage OBS ) Eosinophilic esophagitis FIRAZYR (Japan ) HAE (Ph2/3) SHP616 (CINRYZE) ( Japan )* HAE prophylaxis NATPAR (EU) Hypoparathyroidism SHP606 ( lifitegrast ) Dry eye disease Rare Diseases Programs INNOVATION Changes since Q3 2015 • CINRYZE SC, CINRYZE AMR, SHP621 and SHP643 (DX2930) have entered Phase 3 studies. • INTUNIV (Japan ) moved into registration. • Totality of SHP625 data being assessed; programs under review. SHP630 adRP SHP640 (FST - 100)* Infectious Conjunctivitis SHP620 ( maribavir )* CMV in transplant patients SHP637 MRT for CF SHP639 Glaucoma SHP609 Hunter IT ( Ph 2/3) SHP611 MLD ( Ph 1/2) Programs are Phase 3 ready * SHP643 (DX2930) Prophylaxis of HAE SHP465 ADHD SHP555 (US) Chronic Constipation GATTEX (Japan) Short bowel syndrome SHP641 MRT for UCD INTUNIV (Japan) ADHD
15 • 14 programs in Phase 3, or Phase 3 ready • Three programs recently advanced into Phase 3: • Dyax acquisition adds another Phase 3 asset SHP643 (DX2930) to our growing HAE franchise • Phase 3 study of SHP620 ( maribavir ) in CMV infection in transplant patients planned to start Q2 2016 Subcutaneous (SC) CINRYZE (SHP616) for the prophylaxis of hereditary angioedema (HAE) Multiple Phase 3 programs underway SHP616 (AMR) SHP616 SC SHP621 CINRYZE (SHP616) for Antibody Mediated Rejection (AMR) in patients receiving kidney transplants SHP621 for eosinophilic esophagitis ( EoE ) INNOVATION
16 Key clinical and regulatory milestones in 2016 Q1 Q2 Q3 Q4 SHP610 SanFilippo A Disease Phase 2 data Firazyr HAE Japan Top - line data SHP465 Pediatric ADHD Phase 3 data (1) C linical trial results Regulatory filing or anticipated approval Lifitegrast Adult Dry Eye Disease FDA refiled Jan 22, 2016 SHP607 Retinopathy of Prematurity Phase 2 data Lifitegrast PDUFA date: July 22, 2016 SHP465 FDA refiling (1) 1 SHP465 is currently being developed for use in adults. The ongoing pediatric trial is to generate data in support of an adult in dication 2 Subject to approval by regulatory authorities Note: Timings are approximated to the nearest quarter NATPAR Anticipated EU approval (2) INNOVATION
17 PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Lifitegrast : Dry Eye Disease (DED) SHP639:Glaucoma SHP630: Autosomal Dominant Retinitis Pigmentosa • Acquired in 2013 • If approved, lifitegrast will be first new prescription drug for DED in the US in over 10 years with the potential to be the first indicated to treat both signs and symptoms Shire’s commitment to b ecoming a l eader in ophthalmics SHP640: Viral/Bacterial Conjunctivitis SHP607: Retinopathy of Prematurity (ROP) • A cquired in 2013 • First - in - class investigational treatment that may prevent ROP • Acquired in 2015 • If approved, has potential to treat both bacterial and viral eye infections • Acquired in 2014 • Potential treatment for rare and visually debilitating genetic disease where there are no current treatments • Internal pipeline program acquired through Jerini acquisition
18 Lifitegrast PDUFA date: July 22, 2016 • NDA resubmission package included results from the positive Phase 3, OPUS - 3 study as well as product quality information • Largest clinical trial program for an investigational - stage compound for dry - eye disease (>2,500 patients (1) ) • Prescription Drug User Fee Act (PDUFA) date July 22, 2016 (1) Includes one Phase 2 study, three Phase 3 safety and efficacy studies (OPUS - 1, - 2, - 2) and one long - term (one year) Phase 3 safe ty study (Sonata) (2) Subject to regulatory approval INNOVATION Anticipate potential approval and launch in Q3 2016 (2)
Our purpose We enable people with life - altering conditions to lead better lives. Financial Review Jeff Poulton, Chief Financial Officer
20 (1) Results from continuing operations including NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015) and ViroPharma Inc. in 2014 (acquired on January 24, 2014) and excluding DERMAGRAFT in 2014 (treated as a discontinued operation following divestment on January 17, 2014). (2) This is a Non GAAP financial measure. Constant exchange rates ("CER") performance is determined by comparing 2015 performance (res tat ed using average 2014 foreign exchange rates for the relevant period) to actual 2014 reported performance. (3) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Income (FY 2015: $1,303m, FY 201 4: $3,406m). (4) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Income margin (FY 2015: 20%, FY 2014: 57%). (5) Non GAAP EBITDA as a percentage of product sales, excluding royalties and other revenues. (6) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is EPS - ADS (FY 2015: $6.59, FY 2014: $17.28) . (7) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Cash provided by operating ac tiv ities (FY 2015: $2,337m, FY 2014: $4,228m). (8) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. FY 2015 $m (1) FY 2014 $m (1) Reported Growth CER Growth (2)(8) FY Guidance Actual vs. Guidance Product Sales 6,100 5,830 +5% +9% +4 - 5% Product Sales excluding INTUNIV 6,035 5,503 +10% +14% Low double digit Royalties and Other Revenues 317 192 +65% +70% +45 - 55% Total Revenue 6,417 6,022 +7% +11% Non GAAP EBITDA (3)(8) 2,924 2,756 +6% +10% Non GAAP EBITDA margin (4)(5)(8) 43% 44% - 1% point - 2% points Non GAAP diluted EPS – ADS (6)(8) 11.68 10.60 +10% +14% Mid - to - high single digit Non GAAP Cash Generation (7)(8) 2,422 2,402 +1% ✓ ✓ Strong performance drives delivery of double digit Non GAAP diluted EPS growth
21 (1) Results from continuing operations including NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015) and ViroPharma Inc. in 2014 (acquired on January 24, 2014) and excluding DERMAGRAFT in 2014 (treated as a discontinued operation following divestment on January 17, 2014). (2) Gattex growth on a pro - forma basis, including product sales recorded by NPS prior to acquisition by Shire. (3) This is a Non GAAP financial measure. Constant exchange rates ("CER") performance is determined by comparing 2015 performance (r estated using average 2014 foreign exchange rates for the relevant period) to actual 2014 reported performance. (4) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. Growth across the portfolio and the inclusion of NPS drives product sales up 14% (excluding INTUNIV and at CER) CER (3)(4) : Core product sales up $787m or 14% FX headwinds holds back reported product sales by $257m or 4 % INTUNIV generic entry holds back reported product sales by $260m or 5%
22 (1) Results from continuing operations including NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015) and ViroPharma Inc. in 2014 (acquired on January 24, 2014) and excluding DERMAGRAFT in 2014 (treated as a discontinued operation following divestment on January 17, 2014). (2) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is R&D (FY 2015: +47%, FY 2014: +14%). (3) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is SG&A (FY 2015: +16%, FY 2014: +23%) . (4) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Combined R&D and SG&A (FY 2015: +26%, FY 2014: +20%). (5) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Gross Margin (FY 2015: 84.1%, FY 2014: 83.2%). (6) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is R&D (FY 2015: 26%, FY 2014: 18%). (7) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is SG&A (FY 2015: 38%, FY 2014: 35%) . (8) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net income Margin (FY 2015: 20%, FY 2014: 57%). (9) Excluding Royalties and Other Revenues. (10) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. Year on Year Change: FY 2015 (1) Product Sales +5% Product Sales excluding INTUNIV +10% Non GAAP R&D (2)(10) +5% Non GAAP SG&A (3)(10) +8% Combined Non GAAP R&D and SG&A (4)(10) +7% Ratios: FY 2015 (1) FY 2014 (1) % of Product Sales Non GAAP Gross Margin (5)(10) 85.5% 85.8% Non GAAP R&D (6)(10) 14% 14% Non GAAP SG&A (7)(10) 28% 27% Non GAAP EBITDA (8)(9)(10) 43% 44% Strong Non GAAP EBITDA margin in 2015 whilst investing for future growth
23 (2,847) (32) (134) 650 (5,553) 2,222 (115) (85) 2,422 (1) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net cash provided by operating ac tiv ities (FY 2015: $2,337m, FY 2014: $4,228m). (2) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Cash and cash equivalents (Decemb er 31, 2015: $136m, December 31, 2014: $2,982m). (3) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30 . (4) Net debt as at January 31, 2016 was approximately $7bn following the acquisition of Dyax . At December 31, 2015 Shire had a $2.1bn revolving credit facility that matures in December 2020. Shire also had a $0.75bn term l oan facility maturing in July 2016 (with a 6 month extension option) which partially funded the NPS Pharma acquisition, and a $5.6bn 3 year amortizing term loan facility maturing in November 2018 available to fund the acquisition of Dyax . Continued strong cash generation in 2015, Non GAAP net debt of $1.5B at December 31, 2015 December 31, 2015 $m (4) December 31, 2014 $m Cash and cash equivalents 136 2,982 Long - term borrowings (70) - Short - term borrowings (1,512) (850) Other debt (13) (13) Non GAAP Net (debt)/cash (2)(3) (1,459) 2,119 Non GAAP Cash Generation (1)(3) Non GAAP Free Cash Flow (1)(3) Dividend payment Net Cash outflow Tax and Interest payment Capital expenditure Net draw down of facility and term loans Other investing and financing Payments for business combinations
24 (1) Results from continuing operations including NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015 ). (2) Based on a latest assumption of a full year 2016 weighted average number of ordinary shares of approximately 595 million . (3) This is a Non GAAP financial measure. Constant exchange rates ("CER") performance is determined by comparing 2016 performance (restated using average 2015 foreign exchange rates for the relevant period) to actual 2015 reported performance . (4) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconciliation of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. 2016 Guidance : Includes Dyax - Excludes Baxalta Full Year 2016 Dynamics CER Growth (3)(4) Impact of FX Rates on Guidance Guidance (1) Total Product Sales 13 - 17% - 2 to - 3% points 11 - 14% higher than in 2015 Royalties & Other Revenues 5 - 10% higher than in 2015 Non GAAP Gross Margins (4) Similar to 2015 levels Non GAAP Combined R&D and SG&A (4) 12 - 14% higher than in 2015 Non GAAP Net Interest/Other (4) 1.5 to 2 times 2015 levels Non GAAP Tax Rate (4) Core effective tax rate of 16 - 18% Non GAAP D iluted Earnings per ADS (2)(4) 9 - 13% - 2 to - 3% points 7 - 10% higher than in 2015 Capital Expenditure ~$300m Our 2016 Outlook is based on January 31, 2016 exchange rates holding through 2016: Exchange Rate EUR $1.08 GBP $1.42 CHF $0.98 CAD $0.71
Our purpose We enable people with life - altering conditions to lead better lives. Summary Flemming Ornskov, M.D., Chief Executive Officer
26 Creating a global leader in Rare Diseases Continued execution Delivering results in 2015 … G rowth in revenues and earnings Execution of strategy is delivering 2016 priorities Expand and strengthen manufacturing Launch lifitegrast (2) Advance SHP607 (ROP), SHP643 (HAE) and SHP465 (ADHD) Advance Shire’s largest number of Phase 3 trials ✓ GROWTH EFFICIENCY ✓ INNOVATION ✓ PEOPLE ✓ …and beyond Integrate Dyax and Baxalta (1) (1) Pending completion of Baxalta acquisition. (2) Subject to approval by regulatory authorities.
Questions and Answers
Our purpose We enable people with life - altering conditions to lead better lives. APPENDIX
29 Double digit fourth quarter product sales growth (excluding INTUNIV at CER) and delivery of robust Non GAAP EBITDA margin (1) Results include NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015). (2) This is a Non GAAP financial measure. Constant exchange rates ("CER") performance is determined by comparing 2015 performance (r estated using average 2014 foreign exchange rates for the relevant period) to actual 2014 reported performance. (3) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Income ( Q4 2015: $281m, Q4 2014: $2,172m). (4) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Income margin (Q4 2015: 16%, Q4 2014: 138%). (5) Non GAAP EBITDA as a percentage of product sales, excluding royalties and other revenues. (6) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is EPS - ADS (Q4 2015: $1.42, Q4 2014: $11.02). (7) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Cash provided by operating activities (Q4 2015: $762m, Q4 2014: $2,555m). (8) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. Q4 2015 $m (1) Q4 2014 $m Reported Growth CER Growth (2)(8) Product Sales 1,624 1,501 +8% +12% Product Sales excluding INTUNIV 1,604 1,453 +10% +14% Royalties and Other Revenues 92 75 +22% +24% Total Revenue 1,716 1,576 +9% +13% Non GAAP EBITDA (3)(8) 797 694 +15% +17% Non GAAP EBITDA margin (4)(5)(8) 43% 41% 2% points 2% points Non GAAP diluted EPS – ADS (6)(8) 2.97 2.63 +13% +15% Non GAAP Cash Generation (7)(8) 813 800 +2%
30 (1) Results include NPS Pharma Inc. in 2015 (acquired on February 21, 2015). (2) Gattex growth on a pro - forma basis, including product sales recorded by NPS prior to acquisition by Shire. (3) This is a Non GAAP financial measure. Constant exchange rates ("CER") performance is determined by comparing 2015 performance (r estated using average 2014 foreign exchange rates for the relevant period) to actual 2014 reported performance. (4) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. CER (3)(4) : Core product sales up $209m or 14% FX headwinds holds back reported product sales by $58m or 4% INTUNIV generic entry holds back reported product sales by $28m or 2% Strong product sales growth in Q4 2015, up 14% (excluding INTUNIV and at CER)
31 (1) Results from continuing operations including NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015). (2) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is R&D (Q4 2015: +46%, Q4 2014: +5%). (3) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is SG&A (Q4 2015: +10%, Q4 2014: +27 %). (4) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Combined R&D and SG&A (Q4 2015: + 20% , Q4 2014: +20%). (5) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Gross Margin (Q4 2015: 84.6%, Q4 2014: 85.4%). (6) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is R&D (Q4 2015: 22%, Q4 2014: 16%). (7) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is SG&A (Q4 2015: 39%, Q4 2014: 38%) . (8) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net income Margin (Q4 2015: 16%, Q4 2014: 138%). (9) Excluding Royalties and Other Revenues. (10) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. Year on Year Change: Q4 2015 (1) Product Sales +8% Product Sales excluding INTUNIV +10% Non GAAP R&D (2)(10) - 2% Non GAAP SG&A (3)(10) +4% Combined Non GAAP R&D and SG&A (4)(10) +2% Ratios: Q4 2015 (1) Q4 2014 (1) % of Product Sales Non GAAP Gross Margin (5)(10) 85.8% 86.3% Non GAAP R&D (6)(10) 14% 15% Non GAAP SG&A (7)(10) 28% 30% Non GAAP EBITDA (8)(9)(10) 43% 41% Q4 2015 Financial Ratios
32 (1) Results from continuing operations including NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015) and ViroPharma Inc. in 2014 (acquired on January 24, 2014) and excluding DERMAGRAFT in 2014 (treated as a discontinued operation following divestment on January 17, 2 014 ). US Europe LATAM Other Total Q4 2015 Product Sales $m (1) 1,188 274 55 107 1,624 % of Product Sales 73% 17% 3% 7% 100% YoY Growth +12% - 5% +22% +4% +8% FY 2015 Product Sales $m (1) 4,454 1,043 202 401 6,100 % of Product Sales 73% 17% 3% 7% 100% YoY Growth +9% - 9% - 6% +4% +5% FY 2014 Product Sales $m (1) 4,082 1,147 214 387 5,830 % of Product Sales 70% 20% 4% 6% 100% YoY Growth +28% +13% +3% +10% +23% Product Sales – Regional analysis
33 (1) Results include NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015), and ViroPharma Inc. in 2014 (acquired on January 24, 2014) and excluding DERMAGRAFT in 2014 (treated as a discontinued operation following divestment on January 17, 2014). Royalties and Other Revenues FY 2015 $m (1) FY 2014 $m (1) Reported Growth Q4 2015 $m (1) Q4 2014 $m Reported Growth SENSIPAR 115 - n/a 34 - n/a 3TC and ZEFFIX 49 34 +45% 19 9 +106% FOSRENOL 46 51 - 10% 14 15 - 6% INTUNIV 28 22 +26% - 22 n/a ADDERALL XR 26 29 - 10% 4 6 - 36% Other 37 25 +50% 11 7 +46% Royalties 301 161 +87% 82 59 +39% Other Revenues 16 31 - 47% 10 16 - 39% Royalties & Other Revenues 317 192 +65% 92 75 +22%
34 (1) Results from continuing operations including NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015) and ViroPharma Inc. in 2014 (acquired on January 24, 2014) and excluding DERMAGRAFT in 2014 (treated as a discontinued operation following divestment on January 17, 2014). (2) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Gross Margin (Q4 2015: 84.6%, Q4 2014: 85.4%, FY 2015: 84.1%, FY 2014: 83.2%). (3) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Combined R&D and SG&A (Q4 2015: +20%, Q4 2014: +20%, FY 2015: +26%, FY 2014: +20 %). (4) Non GAAP EBITDA as a percentage of product sales, excluding royalties and other revenues. (5) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net income Margin (Q4 2015: 16%, Q4 2014: 138%, FY 2015: 20%, FY 2014: 57%). (6) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Tax rate (Q4 2015: 16%, Q4 2014: 6 %, FY 2015: 3%, FY2014: 2%). (7) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is EPS - ADS (Q4 2015: $1.42, Q4 2014: $ 11.02, FY 2015: $6.59, FY 2014: $17.28 ). (8) FY 2016 guidance includes the effect of Dyax , but excludes the effect of Baxalta . (9) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. Shire income statement growth analysis 2014 Q1 (1) 2014 Q2 (1) 2014 Q3 (1) 2014 Q4 (1) 2014 FY (1) 2015 Q1 (1) 2015 Q2 (1) 2015 Q3 (1) 2015 Q4 (1) 2015 FY (1) FY 2016 Dynamics (8) Guidance Total Product Sales $1,307m $1,470m $1,552m $1,501m $5,830m $1,423m $1,476m $1,577m $1,624m $6,100m 11 - 14% higher than in 2015 versus prior year +19% +22% +33% +17% +23% +9% +0% +2% +8% +5% Royalties & Other Revenues $40m $32m $45m $75m $192m $65m $82m $78m $92m $317m 5 - 10% higher than in 2015 versus prior year - 14% - 27% +8% +65% +8% +68% +150% +73% +22% +65% Total Revenue $1,347m $1,502m $1,597m $1,576m $6,022m $1,488m $1,558m $1,655m $1,716m $6,417m versus prior year +18% +20% +32% +19% +22% +11% +4% +4% +9% +7% Non GAAP Gross Margin (2)(8) 86% 85% 86% 86% 86% 86% 86% 84% 86% 86% Similar to 2015 levels Combined Non GAAP R&D and SG&A (3)(8) $539m $602m $618m $677m $2,436m $571m $697m $652m $688m $2,608m 12 - 14% higher than in 2015 versus prior year - 3% +2% +10% +11% +5% +6% +16% +5% +2% +7% Non GAAP EBITDA Margin (4)(5)(9) 45% 44% 46% 41% 44% 46% 39% 43% 43% 43% Non GAAP Tax Rate (6)(9) 20% 16% 18% 19% 18% 17% 13% 10% 21% 16% Core effective tax rate of 16 - 18% Non GAAP diluted Earnings per ADS (7)(9) $2.36 $2.67 $2.93 $2.63 $10.60 $2.84 $2.63 $3.24 $2.97 $11.68 7 - 10% higher than in 2015 versus prior year +38% +42% +60% +17% +38% +20% - 2% +11% +13% +10%
35 Non GAAP cash flow measures Non GAAP cash generation and Non GAAP free cash flow reconciliation FY 2015 $m FY 2014 $m Reported Growth Q4 2015 $m Q4 2014 $m Reported Growth Non GAAP cash generation (1)(2) 2,422 2,402 +1% 813 800 +2% Tax and interest payments, net (85) (213) (51) (49) Up - front payments in respect of in - licensed and acquired products - (13) - - Receipt from the Canadian revenue authorities - 417 - 169 Receipt of Break Fee - 1,635 - 1,635 US GAAP Net cash provided by operating activities 2,337 4,228 - 45% 762 2,555 - 70% Capital expenditure (115) (77) (53) (28) Up - front payments in respect of in - licensed and acquired products - 13 - - Receipt of Break Fee - (1,635) - (1,635) Non GAAP free cash flow (1)(2) 2,222 2,529 - 12% 709 892 - 21% (1) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net cash provided by operating ac tiv ities (see details above). (2) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30.
36 (1) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Cash and Cash equivalents (Dec 31, 2015: $136m, Dec 31, 2014: $2,982m). (2) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30 . (3) Net debt as at January 31, 2016 was approximately $7bn following the acquisition of Dyax . At December 31, 2015 Shire had a $2.1bn revolving credit facility that matures in December 2020. Shire also had a $0.75bn ter m l oan facility maturing in July 2016 (with a 6 month extension option) which partially funded the NPS Pharma acquisition, and a $5.6bn 3 year amortizing term loan facility maturi ng in November 2018 available to fund the acquisition of Dyax . Non GAAP net (debt)/ cash December 31, 2015 $m (3) December 31, 2014 $m Cash and cash equivalents 136 2,982 Long term borrowings (70) - Short term borrowings (1,512) (850) Other debt (13) (13) Non GAAP net (debt)/cash (1)(2) (1,459) 2,119
37 (1) Results from continuing operations including NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015) and ViroPharma Inc. in 2014 (acquired on January 24, 2014) and excluding DERMAGRAFT in 2014 (treated as a discontinued operation following divestment on January 17, 2014). (2) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is US GAAP Operating income (see det ail s above). (3) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. FY 2015 – Operating Income US GAAP and Non GAAP FY 2015 $m (1) FY 2014 $m (1) Reported Growth Non GAAP Operating Income (2)(3) from continuing operations 2,786 2,593 +7% Intangible asset amortization (499) (244) Impairment of IPR&D intangible assets (644) (190) Legal and litigation costs (10) (9) Integration and acquisition costs (71) (263) Gains on sale of product rights 15 88 Reorganization costs (98) (181) Other (59) (96) US GAAP Operating Income from continuing operations 1,420 1,698 - 16%
38 (1) Results include NPS Pharmaceuticals Inc. in 2015 (acquired on February 21, 2015). (2) This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is US GAAP Operating income (see det ail s above). (3) See slide 39 for a list of items excluded from the US GAAP equivalent used to calculate all Non GAAP measures detailed above. A reconcilia tio n of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire's Q4 2015 earnings release on pages 24 to 30. Q4 2015 – Operating Income US GAAP and Non GAAP Q4 2015 $m (1) Q4 2014 $m (1) Reported Growth Non GAAP Operating Income (2)(3) from continuing operations 764 656 +17% Intangible asset amortization (146) (62) Impairment of IPR&D intangible assets (120) (2) Legal and litigation costs (5) (2) Integration and acquisition costs (95) (4) Gains on sale of product rights 2 2 Reorganization costs (38) (58) Other (5) (49) US GAAP Operating Income from continuing operations 357 481 - 26%
39 This presentation contains financial measures not prepared in accordance with US GAAP. These measures are referred to as “Non GA AP” measures and include: Non GAAP operating income; Non GAAP net income; Non GAAP diluted earnings per ADS; effective tax rate on Non GAAP income before income taxes and earnings/(losses) of equity method investees (“effective tax rate on Non GAA P income”); Non GAAP cost of product sales; Non GAAP gross margin; Non GAAP R&D ; Non GAAP SG&A ; Non GAAP other income/(expense); Non GAAP interest income; Non GAAP cash generation; Non GAAP free cash flow, Non GAAP net cas h/(debt), Non GAAP EBITDA and Non GAAP EBITDA Margin (excluding royalties and other revenues). These Non GAAP measures exclude the effect of certain cash and non - cash items, that Sh ire's management believes are not related to the core performance of Shire’s business. These Non GAAP financial measures are used by Shire’s management to make operating decisions because they facilitate internal co mparisons of Shire’s performance to historical results and to competitors’ results. Shire’s Remuneration Committee uses certain key Non GAAP measures when assessing the performance and compensation of employees, inclu din g Shire’s directors. The Non GAAP measures are presented in this presentation as Shire’s management believe that they will provide investors with a m eans of evaluating, and an understanding of how Shire’s management evaluates, Shire’s performance and results on a comparable basis that is not otherwise apparent on a US GAAP basis, since many non - recurring, infre quent or non - cash items that Shire’s management believe are not indicative of the core performance of the business may not be excluded when preparing financial measures under US GAAP. These Non GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures pre par ed in accordance with US GAAP. Where applicable the following items, including their tax effect, have been excluded when calculating Non GAAP earnings for b oth 2015 and 2014, and from our Outlook: Amortization and asset impairments: • Intangible asset amortization and impairment charges; and • Other than temporary impairment of investments. Acquisitions and integration activities: • Up - front payments and milestones in respect of in - licensed and acquired products; • Costs associated with acquisitions, including transaction costs, fair value adjustments on contingent consideration and acqui re d inventory; • Costs associated with the integration of companies; and • Noncontrolling interests in consolidated variable interest entities. Divestments, reorganizations and discontinued operations: • Gains and losses on the sale of non - core assets; • Costs associated with restructuring and reorganization activities; • Termination costs; and • Income/(losses) from discontinued operations. Legal and litigation costs: • Net legal costs related to the settlement of litigation, government investigations and other disputes (excluding internal leg al team costs). Other: • Net income tax credit ( being income tax, interest and estimated penalties) related to the settlement of certain tax positions with the Canadian revenue authorities; • Costs associated with AbbVie’s terminated offer for Shire, including costs of employee retention awards; and • Break fee received in relation to AbbVie’s terminated offer for Shire. Depreciation, which is included in Cost of product sales, R&D and SG&A costs in our US GAAP results, has been separately disc los ed for the presentation of 2015 and 2014 Non GAAP earnings. Cash generation represents net cash provided by operating activities, excluding up - front and milestone payments for in - licensed and acquired products, tax and interest payments. Free cash flow represents net cash provided by operating activities, excluding up - front and milestone payments for in - licensed a nd acquired products, but including capital expenditure in the ordinary course of business. Growth at CER, which is a Non GAAP measure, is computed by restating 2015 results using average 2014 foreign exchange rates f or the relevant period. Average exchange rates used by Shire for the year to December 31, 2015 were $1.53:£1.00 and $1.11: € 1.00 (2014: $1.65:£1.00 and $1.33: € 1.00). Average exchange rates used by Shire for Q4 2015 were $1.52:£1.00 and $1.09: € 1.00 (2014: $1.60:£1.00 and $1.25: € 1.00). A reconciliation of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented in Shire’s Q4 2015 earnings release on pages 24 to 30. Non GAAP measures
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