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Alchemia Limited (ASX:ACL) Investor Presentation September 2013 For personal use only

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Page 1: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

Alchemia Limited (ASX:ACL) Investor Presentation

September 2013

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Page 2: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

This presentation is being provided for the sole purpose of providing the recipients with background information about Alchemia’s business. This presentation, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendation to subscribe for or purchase any security and neither the presentation, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does not purport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with Alchemia’s other continuous disclosure announcements lodged with the ASX which are available at www.asx.com.au. Before making an investment decision you should consider whether it is suitable for you in light of your own investment profile and objectives and financial circumstances and the merits and risk involved.

No representation, express or implied, is made as to the fairness, accuracy, completeness or correctness of information, opinions and conclusions contained in this presentation, including the accuracy, likelihood of achievement or reasonableness of any forecasts, prospects, returns or statements in relation to future matters contained in the presentation (“forward-looking statements”). Such forward-looking statements are by their nature subject to significant uncertainties and contingencies and are based on a number of estimates and assumptions that are subject to change (and in many cases are outside the control of Alchemia and its Directors) which may cause the actual results or performance of Alchemia to be materially different from any future results or performance expressed or implied by such forward-looking statements. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance.

To the maximum extent permitted by law, neither Alchemia nor its related corporations, directors, employees or agents, nor any other person, accepts any liability, including, without limitation, any liability arising from fault or negligence, for any loss arising from the use of this presentation or its contents or otherwise arising in connection with it.

You represent and confirm by attending and/or retaining this presentation, that you accept the above conditions.

This presentation does not constitute an offer to sell or a solicitation of an offer to buy securities in the United States. The securities have not been registered under the U.S. Securities Act of 1933 or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements.

Disclaimer

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Page 3: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Balanced portfolio

• FDA approved product on market and generating free cash flow to ACL

• Phase III oncology drug trial close to conclusion

• Phase II oncology trials ongoing (Merck Serono)

• Platform technologies

• HyACT , VAST (partnered with AstraZeneca)

• Multiple industry partners

• Dr Reddy’s Laboratories

• AstraZeneca

• Merck Serono

• Strong financial position

• $13m cash balance as at 30 June 2013 plus

• $8.7m R&D refund

• Based in Brisbane/Melbourne, Australia, listed on ASX (ASX:ACL)

• Market capitalisation ~A$170m

• 334 m shares in issue

• Significant near term events/value drivers

Corporate Overview

• Well financed

• Royalty stream from first launched product

• Significant cancer drug in final stage of development

• Multiple pharma collaborations

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Page 4: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• FY13 achievements

• Revenue $24.3m for the year

• Loss of $4.8m for the year

• $9.6m in profit share received from first full year of fondaparinux sales by Alchemia partner Dr Reddy's

• Phase III successfully recruited as planned

• Partnerships established with

• Merck Serono (Phase II clinical trial collaboration)

• AstraZeneca (Drug Discovery Platform)

• Two key assets approaching milestones:

• HA-irinotecan

• Fondaparinux

• Aggressively pursuing options to maximise value

FY13 Overview

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• Feb: Phase III Enrolment Complete

• Apr: Signed $240m AstraZeneca agreement

• May: Signed Merck Serono agreement

• Jul: Board restructured

• Jul: $9.6m free cash flow from fondaparinux for FY12/13

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Page 5: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Near Term (3-6 months) • Potential partnership deal for HA-Irinotecan

• Potential monetization of fondaparinux

• Stabilization and potential growth in fondaparinux profit share

• Medium Term (6-18 months) • Results of pivotal HA- Irinotecan Phase III trial (1H CY2014)

• Potential filing of NDA for HA- Irinotecan for mCRC

• Potential refiling of US IPO (S-1 is currently active)

• Potential manufacturing cost improvements for fondaparinux

• New regulatory approval and launches in new markets for fondaparinux

• Potential launch of new HyACT-enhanced chemotherapy clinical trials

• Additional VAST collaborations with pharmaceutical companies

Potential Catalysts*

• Potential HA-Irinotecan partnership would create very significant benefits including additional pipeline value

• Phase III results are a major valuation inflection point

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* Note that the contents of this slide does not constitute formal guidance and you are advised to review the disclaimer contained herein

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Page 6: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

Name Symbol Market Cap. Preclinical Phase I Phase II Phase III On

Market

Alchemia ACL $170 P P P P P

Acrux ACR $561 P P P P

Bionomics BNO $276 P P P

Mesoblast MSB $1,810 P P P P

Sirtex SRX $738 P P

Starpharma SPL $273 P P

Alchemia’s Position in Australian Biotech

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• Share price rising; ACL still very attractively valued compared with peers

• Products in all stages of development

• Institutional investor base

-

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

1,800,000

2,000,000

$0.25

$0.30

$0.35

$0.40

$0.45

$0.50

13-Jun 20-Jun 27-Jun 04-Jul 11-Jul 18-Jul 25-Jul 01-Aug 08-Aug 15-Aug 22-Aug 29-Aug 05-Sep 12-Sep

Vo

lum

e

Shar

e P

rice

(A

UD

)

ACL: Share price 13 June 2013 to 12 Sept 2013

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Page 7: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

Alchemia Clinical Pipeline – Late Stage & Diversified

• Fondaparinux on the market

• HA-Irinotecan in Phase III and two Phase II trials

• Additional HyACT® products

• VAST® discovery platform extends partnering opportunities

Discovery Phase I Phase II Phase III Market Partner/Status

FONDAPARINUX

Fondaparinux DVT/PE

Marketed by Dr Reddy’s

AUDEO ONCOLOGY

HA-Irinotecan mCRC

100% recruited

HA-Irinotecan SCLC

Investigator-led >60% recruited

HA-Irinotecan ‘CHIME’ mCRC

Investigator-led Merck-Serono

HyACT-chemotherapy

HA-doxorubicin HA-5-FU

HyACT-antibody

HA-cetuximab

VAST Various targets. AstraZeneca

DVT is deep vein thrombosis PE is pulmonary embolism

mCRC is metastatic colorectal cancer SCLC is small cell lung cancer

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Page 8: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

HA-Irinotecan ACL’s most significant product

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Page 9: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• HA-irinotecan is a targeted version of existing chemotherapy, irinotecan, about to complete Phase III clinical testing

• Irinotecan used widely in many different cancers at different stages

• HA- Irinotecan target product profile:

• The same as existing (and widely used) irinotecan but “works better”

• Physicians replace existing irinotecan with HA-Irinotecan

• Priced at or near current novel anti-cancer drugs (over $4k per month)

• HA-Irinotecan’s initial indication is metastatic colorectal cancer (mCRC) as part of an existing widely used treatment for metastatic colorectal cancer – FOLFIRI

• Phase III clinical trial expected to conclude 1H CY2014

• Trial fully funded using existing ACL funds (including Fonda revenues)

HA-Irinotecan: Final Stages of Clinical Testing

• Last stage of development before approval and launch

• First indication is a significant market: colon cancer

• Expect rapid market penetration with drop in replacement

• Expect premium pricing: over $4k per month

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Page 10: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• 415 patients recruited to blinded Alchemia pivotal Phase III trial

• Primary endpoint is “Progression Free Survival” (PFS)

• Target PFS improvement of 8 – 12 weeks

• Trial design- Patient Randomization

• 50% receive standard of care with HA-irinotecan; and

• 50% receive standard of care with irinotecan

• Progression Free Survival (PFS)- primary endpoint: time it takes for the tumour to start growing again or for the patient to die after the start of study therapy

• Study progress is monitored by an independent Data Monitoring Committee; no concerns raised to date

HA-Irinotecan – Phase III Pivotal Trial

• Trial fully recruited

• Patients are staying on drug longer than expected

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Page 11: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Target endpoint is 8 - 12 weeks improvement in PFS

• PFS improvements from other commercial pharmaceuticals:

• Avastin – (2nd line mCRC) PFS improvement of 10.5 weeks

• 2012 total sales of over $6bn (includes other cancers)*

• Erbitux – (1st line mCRC) – PFS improvement of 6.5 weeks

• 2012 total sales of $1.85bn (includes other cancers) *

• Peak sales estimates for HA-irinotecan:

• 8 week PFS generates peak sales estimate of $465m peak sales

• Further, expanded use (1st line mCRC) of HA-irinotecan generates estimated peak sales of $1.7bn (would include additional trial(s))

• Expect 90% gross margin for US market

HA-Irinotecan – Targeting Major Market

• Alchemia is on the threshold of creating a very significant pharmaceutical product, the first from its HyACT platform

* Source: Bloomberg

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Page 12: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

Summary Assumptions:

• Target case: 8 week improvement in PFS over irinotecan and 2nd/3rd line mCRC

• Upper case: 8-12 week improvement and move into 1st line mCRC (would require additional study(ies) after meeting Phase III endpoint)

• Pricing assumptions from Company survey of US oncologists and US payors

Sales Potential For HA-Irinotecan

• Peak sales estimates of $465m to $1,667m depending on results and scale of adoption

• Approx. 140,000 new cases of colon cancer p.a.(Am. Can. Soc)

• Estimated 50,000 US deaths p.a. (Am. Can. Soc)

* company estimates; assumes appropriate clinical trials are positive Page 11

$465

$1,667

$0

$500

$1,000

$1,500

$2,000

Target Case Upper Case

US$

m

Global Peak Sales Estimates*

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Page 13: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Licensing activities underway

• Potential partnership deal for HA-Irinotecan

• Upfront payment

• Milestones

• Royalties

• There are very few late stage oncology clinical assets available for licensing

• Licensing would enable further de-risking and provides for a flexibility with fondaparinux revenue stream

• HA-Irinotecan Phase III trial top-line data expected in 1H CY2014

HA-Irinotecan - 2014 Key Activities

• Potential partnership for HA-Irinotecan

• Phase III trial results

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Page 14: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

HyACT®: Tumor targeting technology for improved anti-cancer drugs

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Page 15: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Targets the tumor cells directly through the cancer target CD44

• Increases the effectiveness of existing chemotherapeutics, without altering their administration or safety

• Can be used for many different chemotherapies

• Lower risk of development than a “new chemical entity”

• Same sale price as a “new chemical entity”

• Most advanced HyACT-enhanced chemotherapy is in the last stage of clinical trials (Phase III)

HyACT Technology

• HyACT improves existing cancer drugs

• Lower development risk than novel drugs

• Retains the high price and value of novel drugs

• HyACT could generate more drugs with the potential of HA-Irinotecan

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Page 16: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

Generic Fondaparinux

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Page 17: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Fondaparinux is an anticoagulant for DVT and PE

• In the market:

• Original version is Arixtra®, marketed by GlaxoSmithKline

• Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011

• Subsequent to ACL’s launch, Apotex launched an authorised generic (AG) version of fondaparinux

• Recently GSK announced its intention to sell global rights to Arixtra® product, and facility to Aspen in a deal of over $1.1 bn

• Total profit share received for FY13 of A$9.6m in first full year of profit share receipts

• Market

• US represents an estimated 65% of the global market and most attractive pricing

• ROW territories less attractive pricing but provide opportunity for cost reduction through economies of scale, and some profit share

• Further potential for growth from reduction in manufacturing costs

Fondaparinux

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• GSK markets Arixtra®

• Apotex markets an Authorised Generic (AG) of Arixtra®

• Dr Reddy’s markets Alchemia’s generic fondaparinux

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Page 18: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

% Market Share by Volume

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• Dr Reddy’s 27% market share by volume for the last quarter

• Dr Reddy's market share has increased by ~50% over the last five quarters

Source: IMS

Quarter ending 30 June 12

Quarter ending 30 Sept 12

Quarter ending 31 Dec 12

Quarter ending 31 March 13

Quarter ending 31 June 2013

Apotex 54% 58% 61% 65% 63%

GSK 28% 20% 14% 12% 10%

Dr Reddy's 18% 22% 25% 23% 27%

18%

22%

25% 23%

27%

0%

10%

20%

30%

40%

50%

60%

70%

Fon

dap

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ux

Mar

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Shar

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USA

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Page 19: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Dr Reddy’s has over 50% market share in the retail sector

• 7% share in the institutional sector

% Market Share (Volume) by Sector

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Source: IMS

Quarter ending 30 June

12

Quarter ending 30 Sept

12

Quarter ending 31 Dec

12

Quarter ending

31 March

13

Quarter ending 31 June

2013

Apotex 56% 70% 76% 79% 80%

GSK 41% 25% 18% 15% 12%

Dr Reddy's 3% 5% 6% 6% 7%

3% 5% 6% 6% 7%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

% M

arke

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are

in N

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-Re

tail

(USA

)

Non-Retail Sales By Volume per Quarter

Quarter ending 30 June

12

Quarter ending 30 Sept

12

Quarter ending 31 Dec

12

Quarter ending

31 March

13

Quarter ending 31 June

2013

Apotex 43% 40% 40% 45% 40%

GSK 13% 11% 9% 8% 7%

Dr Reddy's 43% 49% 51% 48% 53%

43% 49% 51%

48% 53%

0%

10%

20%

30%

40%

50%

60%

% M

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SA)

Retail Sales By Volume per Quarter

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Page 20: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Potential growth/stabilisation of profit share to come from

• Continued competitiveness by Dr Reddy’s US sales force

• Improvement in manufacturing costs

• economies of scale and process improvements

• expiry in December 2014 of Alchemia’s agreement with Dr Reddy’s to contribute $0.5m per quarter for process and production improvements (as announced 24 September 2012)

• Profit share arising from ROW sales

• Potential changes in market dynamics

• Pursuing options to best create shareholder value, including assessing the potential monetization of fondaparinux

• De-risks assets and provides potential upside for shareholders

Fondaparinux – 2014 Key Activities

• Growth/stablisiation of profits to come from reduced costs, new sales and potential changes in market dynamics

• De-risking ACL may lead to additional financial returns to shareholders

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Page 21: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

VAST Drug Discovery Technology

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Page 22: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

VAST® (Versatile Assembly on Stable Templates)

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• VAST® technology enabled development of fondaparinux

• $240m deal signed with AstraZeneca

• R&D expenditure not significant

• Small molecule drug discovery technology with an array of diverse compound shapes

• Strategic collaboration with AstraZeneca AB

• Financially efficient with a focus on productivity through partnerships and grants

• Partnering with industry and academic partners

• Grant funding to support internal collaborative drug discovery programs

• Collaborations with WEHI (oncology), UQ (pain) and MIPS (allosteric modulation)

Classical pharma small molecule shapes

VAST shapes

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Page 23: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

• Drug development company on threshold of transformation

• Strong financial position

• First product already developed, launched and generating free cash flow

• Next product close to market

• Technologies proven to deliver new products

• Strong, global pharma partners

• Significant near term FY 2014 milestones

• Potential partnership deal with HA-Irinotecan

• Strategic options for fondaparinux

• Growth/stablisation in profit share

• Results of pivotal HA-Irinotecan trial

Alchemia - Summary and Prospects

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• ACL is well placed to benefit from its near and mid term catalysts

• FY 2014 is set up to be a transformative year

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Page 24: For personal use only - ASX · • Alchemia’s fondaparinux was first copy, or generic, FDA approved and launched in July 2011 • Subsequent to AL’s launch, Apotex launched an

Thank you

Charles Walker Chief Executive Officer [email protected]

Dr Tracey Brown Chief Scientific Officer (Oncology) [email protected]

Rosemary Cummins Investor Relations [email protected] F

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