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Donnerstag, 26.04.2018 13:01 von GlobeNewswire | Aufrufe: 276

Shire plc : 1st Quarter Results

Eine Wissenschaftlerin prüft eine rote Pille (Symbolbild). © scanrail / iStock / Getty Images Plus / Getty Images http://www.gettyimages.de/

Shire Delivers 7% Product Sales Growth and Robust Pipeline Progress in Q1 2018

Growth driven by Immunology, recently-launched products, and international expansion

Innovative pipeline progresses with 15 programs in Phase 3 and 7 programs in registration including lanadelumab

Delivers Non GAAP diluted earnings per ADS of $3.86, up 6% year-on-year; GAAP diluted earnings per ADS were $1.81, up 47%

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$1.0 billion in net operating cash flow enabled continued debt pay down

April 26, 2018 - Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the leading global biotech company focused on rare diseases, announces unaudited results for the three months ended March 31, 2018.

Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:

"Shire is off to a good start in 2018 delivering on our key priorities of commercial execution, pipeline progression, debt pay down, and portfolio optimization. We generated product sales growth of 7% in the first quarter reaching $3.6 billion with important contributions from our Immunology franchise, recently-launched products, and international markets. We delivered $1.0 billion in net operating cash flow allowing us to remain on track towards our debt pay down target.

"We continue to advance our innovative pipeline with seven programs in registration including lanadelumab, the first monoclonal antibody being evaluated to prevent hereditary angioedema attacks, with the potential to change the treatment paradigm for this serious and sometimes life threatening rare disease.

"As part of the ongoing review of our portfolio, we recently announced an agreement for the sale of our Oncology franchise for $2.4 billion allowing us to unlock embedded value and sharpen our focus."

Product and Pipeline Highlights

Regulatory updates

Advanced lanadelumab with accelerated approval pathways underway in the U.S. (PDUFA date of August 26, 2018), Europe, and Canada.
Gained FDA acceptance for additional key filings: CINRYZE sBLA for pediatric use, including Priority Review; prucalopride NDA; and Calaspargase Pegol BLA.
Achieved marketing approval of XIIDRA (lifitegrast ophthalmic solution 5%) in Canada and ADYNOVI in E.U.
Obtained Breakthrough Therapy Designation for maribavir for cytomegalovirus (CMV) infection in transplant patients from FDA.

Clinical and business development updates

Agreed to divest Oncology franchise to Servier S.A.S. for $2.4 billion.
Formed pre-clinical research collaboration to evaluate a potential enzyme replacement therapy using NanoMedSyn's proprietary synthetic derivatives.

Note: Growth rates are on a reported basis unless mentioned otherwise.

Financial Highlights

	Q1 2018	Reported Growth	Non GAAP CER⁽¹⁾
Product sales Rare Disease⁽²⁾	$2,719 million	+10%	+6%
Product sales Neuroscience⁽²⁾	$918 million	-2%	-4%
Total product sales	$3,637 million	+7%	+3%
Total revenues	$3,766 million	+5%	+2%

Rare Disease contribution margin⁽²⁾	$1,367 million	+2%
Neuroscience contribution margin⁽²⁾	$770 million	-3%

Operating income from continuing operations	$694 million	+40%
Non GAAP operating income⁽¹⁾	$1,467 million	+1%	-3%

Net income	$551 million	+47%
Non GAAP net income⁽¹⁾	$1,173 million	+6%

Diluted earnings per ADS⁽³⁾	$1.81	+47%
Non GAAP diluted earnings per ADS⁽¹⁾⁽³⁾	$3.86	+6%	+2%

Net cash provided by operating activities	$1,010 million	+120%
Non GAAP free cash flow⁽¹⁾	$918 million	+272%

Key ratios

Rare Disease contribution margin percentage⁽²⁾⁽⁴⁾	48%	-3ppc
Neuroscience contribution margin percentage⁽²⁾⁽⁴⁾	82%	+0ppc

Net income margin⁽⁴⁾⁽⁵⁾	15%	+5ppc
Non GAAP EBITDA margin^(1)(4)(5)	43%	-1ppc

⁽¹⁾The Non GAAP financial measures included within this release are explained on pages 26 - 27, and are reconciled to the most directly comparable financial measures prepared in accordance with U.S. GAAP on pages 20 - 22.

⁽²⁾In 2018, Shire created two business segments: a Rare Disease division and a Neuroscience division. As a result, Shire now reports its financial results based on these new segments. Segment contribution margin represents total revenue less cost of sales, direct R&D, and direct selling and marketing expenses. Segment contribution margin percentage represents segment contribution margin as a percentage of segment revenue. For further information, refer to Note 3: Segment reporting on page 19.

⁽³⁾Diluted weighted average number of ordinary shares of 912.1 million.

⁽⁴⁾Percentage point change (ppc).

⁽⁵⁾Calculated as a percentage of total revenues.

Product sales growth

Achieved product sales growth of 10% in our Rare Disease division, with increases across all franchises on a reported basis, driven by Immunology, Hematology, Internal Medicine, and Ophthalmics.
Delivered growth of recently launched products of 77%, primarily due to ADYNOVATE, CUVITRU, and GATTEX, as well as XIIDRA with script growth of 27% since Q1 2017.
Experienced decline of 2% in product sales in our Neuroscience division due to the genericization of LIALDA in the second half of 2017. Excluding the impact of LIALDA, Neuroscience grew 12%, primarily driven by VYVANSE.

Operating performance

Generated Non GAAP diluted earnings per ADS of $3.86, an increase of 6%, as Q1 2018 benefited from higher product sales and a lower tax rate, which were partially offset by lower gross margins due to Q1 2017 favorability from the timing of changes in the costs to manufacture certain products.
Reported Non GAAP EBITDA margin of 43%, a slight decline from Q1 2017, with continued benefit from operating efficiencies in SG&A offset by lower gross margins as discussed above.
Rare Disease reported contribution margin of $1,367 million, or 48%, and Neuroscience reported contribution margin of $770 million, or 82%.

Strong cash flow

Strong free cash flow enabled an $866 million reduction in Non GAAP net debt during the quarter.

FINANCIAL SUMMARY - FIRST QUARTER 2018 COMPARED TO FIRST QUARTER 2017

Revenues

Delivered total revenues of $3,766 million representing growth of 5%.
Rare Disease product sales increased 10% to $2,719 million (Q1 2017: $2,472 million), with growth across all franchises on a reported basis and growth from recently launched products. Rare Disease product sales also benefited from favorable foreign currency exchange in our international markets.
Neuroscience product sales decreased 2% to $918 million (Q1 2017: $940 million), due to the launch of generic competition for LIALDA in the second half of 2017. Excluding the impact from LIALDA, Neuroscience product sales grew 12%.
Royalties and other revenues decreased 20% to $129 million (Q1 2017: $160 million), primarily due to the reclassification of ADDERALL XR from royalty revenue to product sales and other accounting changes as required under the new revenue accounting standard as well as lower SENSIPAR royalties.

Operating results

Rare Disease contribution margin percentage was approximately 48% (Q1 2017: 51%), a slight decline from the prior year due to lower gross margins on sales, partially offset by lower selling and marketing costs.
Neuroscience contribution margin percentage was flat at 82% (Q1 2017: 82%), as the decline in sales due to LIALDA was offset by lower costs.
Operating income increased 40% to $694 million (Q1 2017: $497 million), primarily due to lower expense related to the unwind of inventory fair value adjustments, partially offset by higher amortization of acquired intangible assets and integration and acquisition costs.
Non GAAP operating income increased 1% to $1,467 million (Q1 2017: $1,454 million), with the benefit of our on-going cost reduction initiatives and operating synergies offset by lower gross margins as Q1 2017 reflected favorability from the timing of changes in the costs to manufacture certain products.
Non GAAP EBITDA margin was slightly down to 43% (Q1 2017: 44%), primarily due to the lower gross margin referred to above offset by ongoing cost reduction initiatives and operating expense synergies.

Earnings per share (EPS)

Diluted earnings per American Depository Share (ADS) increased 47% to $1.81 (Q1 2017: 1.23). The increase was primarily driven by operating income as noted above, combined with lower expense related to the unwind of inventory fair value adjustments.
Non GAAP diluted earnings per ADS increased 6% to $3.86 (Q1 2017: 3.63) as Q1 2018 benefited from higher product sales and a lower tax rate partially offset by a lower gross margin.

Cash flows

Net cash provided by operating activities increased 120% to $1,010 million (Q1 2017: $459 million), driven by improvements in working capital, higher operating profitability, and a favorable comparison period as the Q1 2017 period included a payment of $346 million associated with the settlement of the DERMAGRAFT litigation.
Non GAAP free cash flow increased 272% to $918 million (Q1 2017: $247 million), primarily due to the growth in net cash provided by operating activities noted above and a decrease in capital expenditures.

Debt

Non GAAP net debt as of March 31, 2018 decreased $866 million since December 31, 2017, to $18,203 million (December 31, 2017: $19,069 million). A combination of Shire's Non GAAP free cash flow and existing cash balances were utilized to repay debt during the quarter. Non GAAP net debt represents aggregate long and short term borrowings of $18,172 million, and capital leases of $350 million, partially offset by cash and cash equivalents of $318 million.

OUTLOOK

Our 2018 guidance, which continues to include our Oncology franchise, remains unchanged. It will be updated to remove the Oncology franchise upon the close of this pending sale later this year. Similarly, our 2020 guidance remains unchanged and will be updated to remove the Oncology franchise upon the close of this pending sale later this year.

The Non GAAP diluted earnings per ADS forecast assumes a weighted average number of 915 million fully diluted ordinary shares outstanding for 2018.

Our U.S. GAAP diluted earnings per ADS outlook reflects anticipated amortization, integration, and reorganization costs.

Risks associated with this outlook include the potential uncertainty resulting from the announcement by Takeda Pharmaceutical Company Limited that it is considering making a possible offer for Shire.

Full Year 2018	U.S. GAAP Outlook	Non GAAP Outlook⁽¹⁾
Total revenue⁽²⁾	$15.4 - $15.9 billion	$15.4 - $15.9 billion
Gross margin as a percentage of total revenue⁽³⁾	71.0% - 73.0%	73.5% - 75.5%
Combined R&D and SG&A	$5.2 - $5.4 billion	$4.9 - $5.1 billion
Net interest/other	$450 - $550 million	$450 - $550 million
Effective tax rate	15% - 17%	16% - 18%
Diluted earnings per ADS⁽⁴⁾	$7.30 - $7.90	$14.90 - $15.50

⁽¹⁾ For a list of items excluded from Non GAAP Outlook, refer to pages 26 - 27 of this release.

⁽²⁾ Management is providing guidance for total revenue. Total revenue is comprised of total product sales and royalties & other revenues. Pursuant to a change in U.S. GAAP related to accounting for revenue, certain revenue formerly classified as royalties are now recorded as product sales.

⁽³⁾ Gross margin as a percentage of total revenues excludes amortization of acquired intangible assets.

⁽⁴⁾ See page 22 for a reconciliation between U.S. GAAP diluted earnings per ADS and Non GAAP diluted earnings per ADS.

RECENT DEVELOPMENTS

Corporate

Sale of Oncology franchise

On April 16, 2018, Shire announced it has entered into a definitive agreement with Servier S.A.S. to sell its Oncology franchise for $2.4 billion.

Formation of Global Commission to End the Diagnostic Odyssey for Children

On February 20, 2018, Shire, Microsoft, and EURORDIS-Rare Diseases Europe announced a strategic initiative to accelerate time to diagnosis for children with rare diseases.

Business Development

Collaboration with NanoMedSyn

On March 26, 2018, Shire and NanoMedSyn announced a collaboration to conduct pre-clinical research to evaluate a potential enzyme replacement therapy using NanoMedSyn's proprietary synthetic derivatives named AMFA.

Products

VONVENDI for perioperative management of bleeding in adult patients with von Willebrand disease (VWD)

On April 17, 2018, Shire announced that the U.S. Food and Drug Administration (FDA) approved VONVENDI, a recombinant von Willebrand factor treatment for perioperative management of bleeding in adults with VWD. This approval builds on the previously approved on-demand treatment and control of bleeding episodes indication.

myPKFiT for ADVATE software

On March 5, 2018, Shire announced the U.S. availability of myPKFiT for ADVATE, a free web-based software for healthcare professionals that is the first and only pharmacokinetic dosing software cleared by the FDA for use with certain hemophilia A patients treated with ADVATE.

CINRYZE for pediatric hereditary angioedema (HAE)

On February 15, 2018, Shire announced that the FDA had accepted the CINRYZE (C1 esterase inhibitor [human]) supplemental Biologics License Application to expand the currently approved indication to include children aged 6 years and older with HAE. The filing received priority review designation from the FDA.

Pipeline

Lanadelumab (SHP643) for the treatment of HAE

· On February 23, 2018, Shire announced that the FDA had accepted the Biologics License Application (BLA) and granted priority review for lanadelumab with a PDUFA date of August 26, 2018.

· On February 27, 2018, Shire announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had granted an accelerated assessment for lanadelumab. On March 29, 2018, Shire announced that the EMA had validated its marketing authorization application (MAA) and also reported that Health Canada had completed screening and accepted the New Drug Submission (NDS) under priority review.

· On April 18, 2018, Shire announced that Swissmedic validated the MAA for lanadelumab.

Prucalopride (SHP555) for the treatment of chronic idiopathic constipation (CIC)

On March 5, 2018, Shire announced that the FDA had accepted the submission of a New Drug Application (NDA) for prucalopride, which is being evaluated as a potential once-daily treatment option for CIC in adults, with a PDUFA date of December 21, 2018.

Calaspargase Pegol (SHP663) for the treatment of acute lymphoblastic leukemia (ALL)

On February 28, 2018, Shire announced that the FDA had accepted the BLA for Calaspargase Pegol.

Board Committee Change

On April 25, 2018, Gail Fosler, Non-Executive Director of Shire, was appointed as a member of the Remuneration Committee.

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