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Alchemia Limited
ASX:ACL
January 2012For
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Disclaimer
� Alchemia Limited does not make any representation or warranty as to the truth or accuracy, completeness, currency or reliability of any information provided to a potential investor or any other written or oral information made available to any potential investor or its advisers, and does not accept:� any responsibility arising in any way for any errors in or omissions from any information or for
any lack of accuracy, completeness, currency or reliability of any information made available; or
� any liability for any loss or damage suffered or incurred by the recipient or any other person as a result of or arising out of that person placing any reliance on the information or its accuracy, completeness, currency or reliability.
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� The forecasts included in the presentation or any other written or oral forecasts made available to any potential investor or its advisers are not representations as to future matters. These forecasts are based on a large number of assumptions and are subject to significant uncertainties and contingencies, some, if not all, of which are outside the control of Alchemia Limited. No representation is made that any forecast will be achieved. Actual future events may vary significantly from the forecasts. Each potential investor should make and must rely on its own enquiries and investigations regarding the assumptions, uncertainties and contingencies which may affect Alchemia Limited's future operations and values and the impact that a variation of future outcomes may have on Alchemia Limited.For
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Overview
� Commercial stage oncology company� Developing therapeutics based on drug targeting, carbohydrate technology and
drug discovery
� Founded 1995, listed on ASX (ASX:ACL) Dec 2003
� Generic fondaparinux – approved by FDA July 2011� Launched by Dr Reddy’s in US
� Potential to receive first cash receipts mid 2012
� Filing for marketing approval in Europe targeted for early 2012
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� Filing for marketing approval in Europe targeted for early 2012
� HyACT™ - tumor-targeting technology� Pivotal Phase III trial in colorectal cancer recruiting
� Phase II trial in small cell lung cancer (SCLC) recruiting
� Planned spin-out of Alchemia Oncology (HyACT) – 1H 2012� Enables Alchemia Limited to retain 100% of fondaparinux revenues
� Provides independently funded, focused platform for oncology assets
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Pipeline
Agent
(Indication)
Preclinical Phase I Phase II Phase III Filed Marketed Partner
CARDIOVASCULAR
Fondaparinux (VTE)
HyACT® ONCOLOGY
HA-Irinotecan(Colorectal)
Recruiting
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(Colorectal)
HA-Irinotecan(SCLC)
Recruiting
HA-Doxorubicin
HA-5FU
VAST Drug Discovery Platform
VariousTargets
PharmaPartnersF
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Generic Fondaparinux
� Marketed by GSK as Arixtra™� US brand sales 12 months to June 2011 = $338m (+14%)
� Global brand sales 12 months to June 2011 = $540m (+10%)
� Factor Xa inhibitor for prevention of venous thromboembolism
� Partnered worldwide with Dr. Reddy’s� Manufactured in India
� Currently sold in the US
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� Alchemia to receive significant payments from Dr. Reddy’s� 50% of operating profits from US sales of fondaparinux
� Royalties on fondaparinux sales made outside N.America
� Market share ramp up expected early 2012� Full market share expected to produce significant cashflows
� Complexity of synthesis will limit future competition
� Apotex also in market with authorized generic
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HyACT® Technology Platform
� HyACT® ‐ uses hyaluronic acid (HA) to target drugs to tumors� Clear, well established, receptor‐based mechanism (CD44)
� Demonstrates enhanced delivery and uptake of drug by tumor cells
� No change in plasma PK or toxicity profile of delivered drug
� Pivotal Phase III trial in metastatic colorectal cancer� 390 patients, blinded, FOLFIRI vs FOLF HA-Irinotecan
� 12months to recruit, est. 18-20months to primary endpoint (PFS)
‐
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� 12months to recruit, est. 18-20months to primary endpoint (PFS)
� Statistically significant increase in efficacy endpoints seen in randomized Phase II trial of HA‐Irinotecan vs irinotecan in mCRC
� Phase II trial in Small Cell Lung Cancer initiated Sept 2011� Evaluating impact on Cancer Stem Cells and Circulating Tumor Cells
� HyACT® shown to enhance broad range of chemotherapeutics, including antibodies
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Why target CD44?
Cancer stem cellsSeparate and analyse cell populations
CD44 expression/HyACT
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Sensitivity to chemo
Mixture of cell types in tumour
Chemotherapy is less able to kill cancer stem cells leading to treatment failure
CD44 expression/HyACT targeting
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Why target CD44?
CD44 expression
Cancer stem cells� CD44 expression in tumors associated withL
� Cancer stem cells
� Resistance to chemotherapy
� Likelihood of relapse
� Advanced, aggressive/metastatic cancers
� HyACT increases killing of CD44+ cells
Resistance
Regrowth
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*Presented AACR 2010
� HyACT increases killing of CD44+ cells
� 40x increase in potency of irinotecan against colorectal cancer stem cells*
� Up to 1000x uptake of drugs in preclinical testing
� Potential to prevent or delay tumor regrowth
Regrowth
Treatment failure
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Near-term Value Drivers
� Generic fondaparinux approved in the US� Revenues expected mid 2012� Filing in Europe expected 1H 2012� Other territories
� Multiple HyACT oncology trials� Enrollment to Phase III, safety data� Phase II SCLC study, CSC/CTC data
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� Phase II SCLC study, CSC/CTC data� Other trials
� Multiple partnering opportunities for HyACT technology� Supergenerics, lifecycle management, biobetter mAbs
� Encouraging results from evaluation of VAST drug discovery technology� Multiple “big pharma” evaluations ongoingFor
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Financial Summary
� Funding� $4m cash Sept 2011
� $20m (net) fundraising completed 21 December 2012
� Fondaparinux revenues expected H1 2012
� Sufficient funds to conduct phase III trial
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� Capital Structure� 280m shares in issue
� 7m options in issue
� Share price (23 December) A$0.31
� Implied market capitalisation of $A87m
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