q1 results 2015 - sobi · 2020-02-03 · highlights q1 2015 2 business •extended and restructured...

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Geoffrey McDonough │ CEO Alan Raffensperger │ COO Mats-Olof Wallin │ CFO Q1 Results 2015 Stockholm | 6 May 2015

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Page 1: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Geoffrey McDonough │ CEO

Alan Raffensperger │ COO

Mats-Olof Wallin │ CFO

Q1 Results 2015

Stockholm | 6 May 2015

Page 2: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Highlights Q1 2015

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Business

• Extended and restructured distribution agreement with Exelixis for Cometriq™

• Xiapex® approved by the EU Commission for the treatment of Peyronie's disease

• Announced positive top-line efficacy and safety results from phase 3 Alprolix® paediatric study (Kids B-LONG)

Significant events after the reporting period

• Received orphan drug designation for Elocta™ in Switzerland

• Positive CHMP opinions for Orfadin® liquid formulation and 20 mg capsule

Page 3: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

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Highlights Q1 2015

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• Total revenues: SEK 865 M (573) • 39% growth at constant exchange rates

• Product revenues: SEK 633 M (406)• 40% growth at constant exchange rates

• ReFacto® revenues: SEK 232 (168)• 36% growth at constant exchange rates

• Gross margin 60% (56)

• EBITA: SEK 172 M (-288)• 2014 EBITA SEK 37 M excluding Kiobrina®

• Cash flow operations: SEK 169 M (135)

Total Revenue

Product Revenue

ReFacto Revenue

Page 4: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Q1 2015 Revenue by Business Line

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+37%*

+14%*

+36%*

Early StageDevelopment Programmes

Inflammation SEK 198 MUSD 24 M

Genetics & Metabolism

SEK 216 MUSD 26 M

Partner ProductsSEK 202 MUSD 24 M

ReFacto AFSEK 232 MUSD 28 M

HaemophiliaSEK 17 M USD 2 M

*Growth at Constant Exchange Rates

USD 1 = SEK 8,3365

+85%*

+19%*

Page 5: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

ReFacto AF

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• Revenue from manufacturing and royalty SEK 232 M (168)• In constant exchange rates 36%

• Concentration of deliveries in the quarter

• Remaining quarters will be lower than Q1

• Manufacturing revenue SEK 208 M (142)

• Royalty revenue SEK 25 M (26)

Sales (SEK M): ReFacto

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Manufacturing Royalty 4Q-rolling

Page 6: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Alan Raffensperger │ COO

Commercial Results Q1 2015

Stockholm | 6 May 2015

Page 7: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Kineret®

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• Revenue SEK 198 M (124)• In constant exchange rates 37%

• Q1 2014 low due to US wholesaler shift

• Volume growth across Europe and US

• Shift to specialty distribution model for the US market underway in second quarter

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Page 8: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Orfadin

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• Revenue SEK 180 M (76)• In constant exchange rates 115%

• Q1 2014 low due to US stock buy-back

• Last quarter to reflect impact of direct sales model in North America

• Positive CHMP opinions for Orfadin liquid formulation and 20 mg capsule

Sales (SEK M): Orfadin

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Page 9: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Partner Products

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• Revenue SEK 202 M (165)• In constant exchange rates 14%

• Sales milestone for Cometriq SEK 18 M

• Preparations for a mid-year launch of Xiapex for Peyronie’s disease ongoing

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Page 10: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Haemophilia

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• Revenue of SEK 17 M (11)• Based on 2% royalty of sales for Eloctate® and

Alprolix in Biogen territory

• Elocta approval H2 2015

• EU filing for Alprolix on track for H2 2015

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Revenues (SEK M): Haemophilia

Milestone Alprolix Alprolix Eloctate

Page 11: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Mats-Olof Wallin │ CFO

Financial Results Q1 2015

Stockholm | 6 May 2015

Page 12: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Profit and Loss Statement

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•One-time write-down in Q1, 2014 for Kiobrina®, SEK 325 M, with limited cash impact•One-time accrual in Q4, 2014 for Multiferon®, SEK 25 M, with limited cash impact

Amounts in SEK M Q1-15 Q1-14 FY 2014

Total revenues 865 573 2 607

Gross profit 519 320 1 548

Gross Margin 60% 56% 59%

Sales and Administration -219 -156 -750

Research and development -132 -127 -501

Other operating revenues/expenses 4 -325 -341

EBITA 172 -288 -43

Amortizations and write-downs -71 -70 -282

EBIT 102 -358 -325

Financial income/expenses -1 -14 6

Income tax expense 5 43 51

Profit/loss for the period 106 -329 -268

Page 13: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Balance Sheet

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Amounts in SEK M March 2015 March 2014 Dec 2014ASSETS

Intangible 4 192 4 303 4 248

Tangible and financial 189 159 188

Total non-current assets 4 380 4 462 4 436

Inventories 765 678 764

Accounts receivable 647 377 480

Other Receivable 133 133 172

Cash and equivalent 682 574 519

Total current assets 2 226 1 762 1 935

Total Asset 6 606 6 224 6 371

EQUITY AND LIABILITIES

Equity 4 645 4 443 4 523

Long term debt 817 794 816

Long term liabilities 282 274 285

Short term liabilities 862 713 747

Total liabilities 1 961 1 781 1 848

Total equity and liabilities 6 606 6 224 6 371

Page 14: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Net Debt

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• End of quarter cash: SEK 682 M

• Net debt SEK 136 M

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Page 15: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Geoffrey McDonough │ CEO

Summary and Outlook

Stockholm | 6 May 2015

Page 16: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Outlook 2015 - EBITA expectations clarified

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Revenues Sobi expects total revenues for the full year to be in the range of SEK 2,800 to 3,000 M

Gross Margin Gross margin is expected be in the range of 58-60 percent.

Operating Costs Operating costs are projected to increase as the company continues to prepare for the planned launch of Elocta

EBITAEBITA is expected to be in the range SEK 300 – 400 M1

The outlook was first published in the 2014 Q4 and FY report on 19 February 2015.

The outlook for 2015 is based on exchange rates as of 19 February 2015, and excludes revenue from the potential European launch of Elocta.

1The original outlook presented on 19 February 2015 stated that “Sobi expects EBITA to be in line with the adjusted 2014 level”.

Page 17: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Building Our Future

Continued focus on our business and capabilities within rare diseases

1. Diverse, growing, and profitable base business in Europe and North America focused on rare diseases

2. Launching first-to-market long-acting haemophilia factors in Sobi territories – providing forward cash flow to continue to build company

3. Growing the business organically with new partner products, and with a pipeline of early stage rare disease biologics

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Page 18: Q1 Results 2015 - Sobi · 2020-02-03 · Highlights Q1 2015 2 Business •Extended and restructured distribution agreement with Exelixis for Cometriq™ •Xiapex® approved by the

Summary

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• Strong performance from the underlying business• Q1 unusually strong due to ReFacto

deliveries and Cometriq milestone

• Guidance for 2015 reiterated• EBITA range specified for clarity

• Elocta launch preparations and Alprolix filing on track