test tube close up

Progressing with EMA and pipeline

Sunesis Pharmaceuticals 3 August 2016 Update

Sunesis Pharmaceuticals

Progressing with EMA and pipeline

Quarterly update

Pharma & biotech

3 August 2016

Price

US$0.69

Market cap

US$60m

Net cash ($m) 30 June 2016

18.8

Shares in issue

87.0m

Free float

53%

Code

SNSS

Primary exchange

NASDAQ

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

25.5

36.6

(49.6)

Rel (local)

22.3

31.8

(51.0)

52-week high/low

US$1.47

US$0.450

Business description

Sunesis Pharmaceuticals is a pharmaceutical company focused on oncology. Its lead asset is Qinprezo, a chemotherapy for AML, in the approval process in the EU. Sunesis has also developed SNS-062, a BTK inhibitor for CLL for Imbruvica refractory patients, currently in Phase Ia.

Next events

TAK-580 Phase Ib/II results

Q316

SNS-062 Phase Ia results

September 2016

SNS-062 Phase Ib/II start

Q416-Q117

Final EMA decision

H117

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Sunesis Pharmaceuticals is a research client of Edison Investment Research Limited

On 29 July 2016, Sunesis announced financial results for Q216 and provided updated guidance on the Qinprezo and SNS-062 development programs. The company reported a net loss of $10.4m for the quarter on the back of $6.6m in R&D spending. It also announced that it had met the EMA to clarify some of the questions submitted as part of the Qinprezo MAA process. Additionally, Sunesis announced that the first clinical trial data on BTK inhibitor SNS-062 will be released at a medical conference in September 2016.

Year
end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/14

5.7

(43.0)

(0.72)

0.0

N/A

N/A

12/15

3.1

(36.7)

(0.50)

0.0

N/A

N/A

12/16e

2.4

(37.0)

(0.42)

0.0

N/A

N/A

12/17e

1.7

(49.1)

(0.53)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortization of acquired intangibles, exceptional items and share-based payments.

Company met EMA about application questions

The three-month minimum clock stop for the MAA has passed and we expect Sunesis to respond in the coming months. The meeting with the EMA to clarify the questions asked in the process is not surprising given that previous approvals for AML in Europe have not been made on the typical intent-to-treat analyses due to the severity of the disease and lack of treatments.

Target: European partner at time of CHMP opinion

Sunesis has stated that it is seeking a partner for commercialization of Qinprezo in Europe and to support the further development of the drug beyond the initial relapsed and refractory elderly AML indication. The company has said it is in negotiations with multiple partners, with discussions at the due diligence stage. It is targeting an announcement at or around the CHMP opinion expected in H117.

SNS-062 first in human data in September 2016

Sunesis’s BTK inhibitor SNS-062 is currently in a Phase Ia dose ranging study in healthy humans, and Sunesis has announced that initial results from the study will be reported at an ESH medical conference on 9-11 September 2016. These results will inform the design of the Phase Ib/II study planned to start around the end of 2016.

Valuation: $153.8m or $1.77 per basic share

We have slightly decreased our valuation to $153.8m or $1.77 per basic share ($1.42 per diluted share), from $156.2m or $1.80 per basic share ($1.46 per diluted share). The decrease reflects a lower net cash balance for Q216 ($18.8m) and a slight increase in our R&D spending assumptions ($24m from $23m for FY16). This is offset by rolling over our NPVs to Q216. We maintain that Sunesis will need $95m in additional financing to reach profitability in 2021. We will likely update our valuation based on the EMA decision and the conclusion of the European partnering process.

Steady progress on European application and partner

On 29 July 2016 Sunesis provided a corporate update and the Q216 financial results. The company is at a critical juncture as it advances the Qinprezo MAA for acute myeloid leukemia (AML) in Europe and courts potential partners for its commercialization there.

As of the end of July 2016, the application is more than three months into the first question and answer phase of the application (day-120 questions), and the company is still preparing its response to the EMA. The minimum clock stop for this stage is three months, so we should expect the company to submit a response to the EMA in the coming months.

Sunesis announced that as part of this process it has met with the EMA for clarification regarding its requests, but did not provide specific guidance on the timeline for the submission. This may reflect some of the complexities associated with this application. Only two drugs (Vidaza and Dacogen) have been approved for AML in Europe in the last decade, both of which, similar to Qinprezo, did not show a statistically significant survival benefit in the intent-to-treat population of their clinical trials. These approvals rested on the analysis of subsets of patients stratified by risk factors and other treatments. The EMA’s willingness to consider these analyses is somewhat of a special situation due to the severity and lack of viable treatment options for AML.

Concurrently with the EMA question and answer process, the company has been seeking a European partner “who is motivated, well resourced, and experienced,” according to management. Additionally it announced on the conference call that it has advanced to the due diligence stage of negotiation with several partners. The company is targeting a partnership at or around the time of the CHMP decision on Qinprezo.

Finally, the company provided an update on the progress of the development of its Bruton's tyrosine kinase (BTK) inhibitor SNS-062 for the treatment of B-cell malignancies. The drug is currently in a Phase Ia dose escalation study in healthy volunteers. The company announced that it expects the first series of results to be presented at the European School of Haematology (ESH) New Concepts in B-cell Malignancies meeting on September 9th to 11th, 2016. Additionally, if an appropriate dose can be found, the company expects to initiate a Phase Ib/II study around the end of 2016.

Financial results and forecasts

Sunesis reported a net loss of $10.4m for the quarter ending in June 2016, corresponding to an operational cash burn of $9.4m. This spending rate is a slight reduction on a sequential basis from Q116 ($10.7m), but very close to the average for the four previous quarters ($9.4m). SG&A spending continues to decrease on a sequential basis ($4.0m vs $4.3m in Q116), reflecting a pullback that has been in effect since mid-2015 following the decision to focus approval efforts for Qinprezo in Europe. R&D spending was $6.6m for the quarter, which is a slight increase over Q116 ($6.2m) and likely reflects the initiation of the SNS-062 Phase Ia clinical study in healthy volunteers that occurred in late March 2016. This R&D spending was slightly higher than our predictions, and we have adjusted our estimates for the year to $24m from $23m with a smaller increase in later years.

The company completed the note offering initiated in March 2016 and received the final payment of $2.5m (out of the total of $15m) associated with the transaction. Repayment of this debt will begin in Q217 over the subsequent 36 months, which is reflected in our forecasts. The proceeds of the loan were used to repay $8m in previous debt and interest, providing a net (after offering costs) $6.8m toward operations. The company ended the quarter with $33m in cash and investments, which management guided should be sufficient to finance operations through mid-2017.

We currently forecast that the company will require an additional $95m in financing to reach profitability in 2021 ($30m in 2017, $30m in 2018, and $35m in 2020). This financing requirement is in addition to the $87.5m in approval and sales milestones we currently model over this period ($37.5m for TAK-580 approval, $50m in Qinprezo approval and sales milestones). We currently record this financing as illustrative debt in our models.

Valuation

We have slightly decreased our valuation to $153.8m or $1.77 per basic share ($1.42 per diluted share), from $156.2m or $1.80 per basic share ($1.46 per diluted share). This reduction reflects lower net cash ($18.8m vs $28.3m) compared to Q116 and the increase in near-term R&D spending. These effects are offset by rolling over our NPV calculations to Q216. Otherwise, our valuation calculations remain unchanged, as other factors are in line with our expectations. The total number of dilutive shares has been increased to reflect the 1.2m warrants issued with the March 2016 notes. These warrants are currently in the money with an exercise price of $0.5409. We may update our valuation in the future to reflect the progress of the Qinprezo MAA or partnering discussions, as well as following the presentation of SNS-062 Phase Ia data.

Exhibit 1: Sunesis valuation

Development program

Clinical stage

Expected commercialization

Prob. of success

Launch year

Launch pricing ($)

Peak sales ($m)

Patent/exclusivity protection

Royalty/
margin

rNPV
($m)

Qinprezo, Rel/Ref AML EU

MAA submitted

Partnered

60%

2017

53,000

190

2027

30%

$61

Qinprezo, Frontline AML EU

Phase III

Partnered

45%

2021

57,000

220

2027

30%

$23

Qinprezo, MDS EU

Phase I/II

Partnered

30%

2021

57,000

152

2027

30%

$9

Qinprezo, Rel/Ref AML US

Phase III

Partnered

30%

2021

82,000

175

2028

30%

$12

Qinprezo, Frontline AML US

Phase III

Partnered

25%

2021

82,000

269

2028

30%

$16

Qinprezo, MDS US

Phase I/II

Partnered

25%

2021

82,000

174

2028

30%

$10

TAK-580

Phase Ib

Licensed to Takeda

15%

2021

138,000

727

2032

15%

$23

SNS-062

Phase Ia

Proprietary

10%

2022

152,000

605

2034

45%

$38

SNS-229

Preclinical

Proprietary

5%

2022

101,000

320

2031

44%

$5

Unallocated costs (discovery programs, administrative costs, etc.)

($61)

Total

 

 

 

 

 

 

 

 

$135

Net cash and equivalents (Q216) ($m)

$18.8

Total firm value ($m)

$153.8

Total basic shares (m)

87.0

Value per basic share ($)

$1.77

Convertible Pref stock (m)

20.2

Warrants (m)

1.2

Total diluted shares (m)

108.5

Value per diluted share

$1.42

Source: Edison Investment Research, Sunesis Pharmaceuticals reports

Exhibit 2: Financial summary

$000s

2013

2014

2015

2016e

2017e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

7,956

5,734

3,061

2,441

1,697

Cost of Sales

0

0

0

0

(3,353)

Gross Profit

7,956

5,734

3,061

2,441

(1,656)

Research and development

(28,891)

(27,665)

(23,701)

(24,201)

(29,536)

Selling, general & administrative

(10,838)

(23,112)

(18,662)

(13,997)

(14,416)

EBITDA

 

 

(31,701)

(41,312)

(35,764)

(35,666)

(45,612)

Operating Profit (before GW and except.)

(31,681)

(41,283)

(35,737)

(35,658)

(45,608)

Intangible Amortization

0

0

0

0

0

Exceptionals/Other

0

0

0

0

0

Operating Profit

(31,681)

(41,283)

(35,737)

(35,658)

(45,608)

Net Interest

(2,917)

(1,719)

(939)

(1,384)

(3,461)

Other (change in fair value of warrants)

0

0

0

0

0

Profit Before Tax (norm)

 

 

(34,598)

(43,002)

(36,676)

(37,041)

(49,069)

Profit Before Tax (IFRS)

 

 

(34,598)

(43,002)

(36,676)

(37,041)

(49,069)

Tax

0

0

0

0

0

Deferred tax

0

0

0

0

0

Profit After Tax (norm)

(34,598)

(43,002)

(36,676)

(37,041)

(49,069)

Profit After Tax (IFRS)

(34,598)

(43,002)

(36,676)

(37,041)

(49,069)

Average Number of Shares Outstanding (m)

52.2

60.1

72.9

87.9

91.9

EPS - normalised ($)

 

 

(0.66)

(0.72)

(0.50)

(0.42)

(0.53)

EPS - IFRS ($)

 

 

(0.66)

(0.72)

(0.50)

(0.42)

(0.53)

Dividend per share ($)

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

33

42

14

6

2

Intangible Assets

0

0

0

0

0

Tangible Assets

23

42

14

6

2

Other

10

0

0

0

0

Current Assets

 

 

40,492

44,204

46,988

19,141

4,320

Stocks

0

0

0

0

0

Debtors

0

0

0

0

0

Cash

39,293

42,981

46,430

18,310

3,489

Other

1,199

1,223

558

831

831

Current Liabilities

 

 

(25,858)

(19,395)

(12,728)

(5,966)

(7,244)

Creditors

(16,840)

(10,138)

(4,894)

(2,216)

(2,244)

Short term borrowings

(9,018)

(9,257)

(7,834)

(3,750)

(5,000)

Long Term Liabilities

 

 

(12,737)

(2,563)

(610)

(10,583)

(35,583)

Long term borrowings

(9,025)

0

0

(10,527)

(35,527)

Other long term liabilities

(3,712)

(2,563)

(610)

(56)

(56)

Net Assets

 

 

1,930

22,288

33,664

2,598

(38,505)

CASH FLOW

Operating Cash Flow

 

 

(37,423)

(43,181)

(38,731)

(34,954)

(41,071)

Net Interest

0

0

0

0

0

Tax

0

0

0

0

0

Capex

0

(48)

0

0

0

Acquisitions/disposals

0

0

0

0

0

Financing

12,570

56,277

43,826

34

0

Dividends

0

0

0

0

0

Other

0

0

0

0

0

Net Cash Flow

(24,853)

13,048

5,095

(34,920)

(41,071)

Opening net debt/(cash)

 

 

(46,966)

(21,250)

(33,724)

(38,596)

(4,033)

HP finance leases initiated

0

0

0

0

0

Exchange rate movements

0

0

0

0

0

Other

(863)

(574)

(223)

357

0

Closing net debt/(cash)

 

 

(21,250)

(33,724)

(38,596)

(4,033)

37,038

Source: Edison Investment Research, Sunesis Pharmaceuticals reports

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Sunesis Pharmaceuticals and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2016. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

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Frankfurt +49 (0)69 78 8076 960

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London +44 (0)20 3077 5700

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245 Park Avenue, 39th Floor

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Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

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NSW 2000, Australia

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Level 15, 171 Featherston St

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New Zealand

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Sunesis Pharmaceuticals and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2016. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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