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Telix Pharmaceuticals Ltd Interim / Quarterly Report 2018

Oct 30, 2018

31324_rns_2018-10-30_67c249f5-4c90-4582-9082-b1f57a0b61ae.pdf

Interim / Quarterly Report

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Quarterly Cashflow Statement: September 2018 Quarter

Melbourne (Australia) – 31[st] of October 2018 . Telix Pharmaceuticals Limited (ASX:TLX) (“Telix”, the “Company”), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (“MTR”), today releases its Appendix 4C for the September 2018 quarter.

The Company held cash reserves of $37.293 million at the end of September, in line with forecasts. Cash outflows relating to operating expenses were $6.168 million, with total spend on direct R&D activities at $4.465 million. During the quarter the Company received $1.190 million in R&D tax rebate for eligible overseas R&D activities undertaken in 2017.

Significant activities during the quarter included:

  • Agreement with Nihon Medi-Physics Co. for a commercial partnership in renal cancer imaging for the Japanese market

  • Commencement of a research collaboration with the University of Melbourne to investigate the use of MTR products for improved treatments for colorectal cancer patients

  • Receipt from the Department of Innovation, Industry and Science of an advance/ overseas R&D tax finding of A$55.2 million enabling partial recovery of overseas R&D expenditure

  • Extension of an agreement with Endocyte, Inc. (NASDAQ: ECYT) regarding the Telix Group’s provision of prostate cancer imaging technology for Endocyte’s phase III “VISION” clinical trial in select European jurisdictions and the US

  • Receipt of ethics approval to commence the international multi-centre, open-label phase I/II study for the use of TLX101 to treat recurrent glioblastoma

  • Completion of the acquisition of Atlab Pharma SAS including its patent portfolio to support potential indication expansion for TLX591, and the rights to a significant clinical data set that will inform the development of TLX591

Subsequent to the end of the quarter, the Company has announced:

  • Conclusion of a distribution agreement with Cardinal Health for the pharmacy preparation and distribution of the 68Ga-PSMA cold kit developed by ANMI SA and commercialised for the US market by Telix USA

  • Entering into a strategic collaboration with GenesisCare Pty Ltd in relation to radiation oncology studies as part of Telix’s global multi-centre trials in neuro-oncology and urologic oncology

  • Expansion of the partnership with ANMI SA for the scale-up of manufacturing in the USA of the 68Ga-PSMA cold kit in response to increased clinical interest in the product

  • • Extension of the MSA with Cyclotek (Aust) Pty Ltd to include TLX250-CDx for imaging patients with clear cell renal cell cancer (ccRCC) using PET

  • Completion of an interim analysis of the ZIR-DOSE dosimetry bridging study, which demonstrated that the Company’s change of isotope resulted in a meaningfully lower patient radiation dose

  • Commencement of the ZIRCON Phase III study

An Appendix 4C accompanies this announcement.

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About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited (Telix) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX:TLX). For more information visit www.telixpharma.com.

Telix Corporate Contact Dr. Christian Behrenbruch Telix Pharmaceuticals Limited CEO Email: [email protected]

Telix Investor Relations (Australia) Kyahn Williamson WE Buchan Tel: +61 (3) 9866 4722 Email: [email protected]

Telix Investor Relations (US) Lisa Wilson In-Site Communications Tel: +1 212 452 2793 Email: [email protected]

Important Information

This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available. None of the products referred to in this release have obtained a marketing authorization in any jurisdiction.

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Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

+Rule 4.7B

Appendix 4C

Quarterly report for entities subject to Listing Rule 4.7B

Introduced 31/03/00 Amended 30/09/01, 24/10/05, 17/12/10, 01/09/16

Name of entity

Telix Pharmaceuticals Limited

ABN Quarter ended (“current quarter”)
85 616 620 369 September 2018
Consolidated statement of cash flows Consolidated statement of cash flows Current quarter Year to date
$A’000 (9 months)
$A’000
1. Cash flows from operating activities
1.1 Receipts from customers - -
1.2 Payments for
(a) research and development including
R&D manufacturing (4,465) (8,534)
(b) product manufacturing and operating - -
costs
(c) advertising and marketing (124) (124)
(d) leased assets - -
(e) staff costs (762) (2,232)
(f)
administration and corporate costs
(817) (2,677)
1.3 Dividends received (see note 3) - -
1.4 Interest received 103 269
1.5 Interest and other costs of finance paid - -
1.6 Income taxes paid - -
1.7 Government grants and tax incentives 1,190 1,190
1.8 Other (provide details if material)
1.9 Net cash from / (used in) operating (4,875) (12,108)
activities
2. Cash flows from investing activities
2.1 Payments to acquire:
(a) property, plant and equipment - -
(b) businesses (see item 10) - -
(c) investments - -
  • See chapter 19 for defined terms 1 September 2016

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Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

Consolidated statement of cash flows Consolidated statement of cash flows Current quarter Year to date
$A’000 (9 months)
$A’000
(d) intellectual property (407) (407)
(e) other non-current assets - -
2.2 Proceeds from disposal of:
(a) property, plant and equipment - -
(b) businesses (see item 10) - -
(c) investments - -
(d) intellectual property - -
(e) other non-current assets - -
2.3 Cash flows from loans to other entities
2.4 Dividends received (see note 3) - -
2.5 Other (provide details if material) - -
2.6 Net cash from / (used in) investing (407) (407)
activities
3. Cash flows from financing activities
3.1 Proceeds from issues of shares - -
3.2 Proceeds from issue of convertible notes - -
03.3 Proceeds from exercise of share options - -
3.4 Transaction costs related to issues of - -
shares, convertible notes or options
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7 Transaction costs related to loans and - -
borrowings
3.8 Dividends paid - -
3.9 Other (provide details if material) - -
3.10 Net cash from / (used in) financing - -
activities
4. Net increase / (decrease) in cash and
cash equivalents for the period
4.1 Cash and cash equivalents at beginning of 42,041 48,695
quarter/year to date
4.2 Net cash from / (used in) operating (4,875) (12,108)
activities (item 1.9 above)
4.3 Net cash from / (used in) investing activities (407) (407)
(item 2.6 above)
4.4 Net cash from / (used in) financing activities - -
(item 3.10 above)
  • See chapter 19 for defined terms 1 September 2016

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Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

Consolidated statement of cash flows Consolidated statement of cash flows Current quarter Year to date
$A’000 (9 months)
$A’000
4.5 Effect of movement in exchange rates on 534 1113
cash held
4.6 Cash and cash equivalents at end of 37,293 37,293
quarter
5. Reconciliation of cash and cash Current quarter Previous quarter
equivalents $A’000 $A’000
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
5.1 Bank balances 21,527 26,375
5.2 Call deposits 15,766 15,666
5.3 Bank overdrafts - -
5.4 Other (provide details) - -
5.5 Cash and cash equivalents at end of 37,293 42,041
quarter (should equal item 4.6 above)
6. Payments to directors of the entity and their associates Current quarter
$A'000
6.1 Aggregate amount of payments to these parties included in item 1.2 172
6.2 Aggregate amount of cash flow from loans to these parties included -
in item 2.3
6.3 Include below any explanation necessary to understand the transactions included in
items 6.1 and 6.2
7. Payments to related entities of the entity and their Current quarter
associates $A'000
7.1 Aggregate amount of payments to these parties included in item 1.2 951
7.2 Aggregate amount of cash flow from loans to these parties included -
in item 2.3
7.3 Include below any explanation necessary to understand the transactions included in
items 7.1 and 7.2
Amounts noted in 7.1 were paid to ABX CRO a clinical research organisation that specialises in
radiopharmaceutical product development. Executive Director Dr Andreas Kluge is the principal
owner and Managing Director of ABX CRO.
  • See chapter 19 for defined terms 1 September 2016

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Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

8. Financing facilities available Total facility amount Amount drawn at
Add notes as necessary for an at quarter end quarter end
understanding of the position $A’000 $A’000
8.1 Loan facilities Nil Nil
8.2 Credit standby arrangements Nil Nil
8.3 Other (please specify) Nil Nil
8.4 Include below a description of each facility above, including the lender, interest rate and
whether it is secured or unsecured. If any additional facilities have been entered into or are
proposed to be entered into after quarter end, include details of those facilities as well.
9. Estimated cash outflows for next quarter $A’000
9.1 Research and development including R&D 5,031
manufacturing
9.2 Product manufacturing and operating costs -
9.3 Advertising and marketing -
9.4 Leased assets -
9.5 Staff costs 503
9.6 Administration and corporate costs 870
9.7 Other (provide details if material) 631
9.8 Total estimated cash outflows 7,035
10. Acquisitions and disposals of Acquisitions Disposals
business entities
(items 2.1(b) and 2.2(b) above)
10.1 Name of entity Atlab Pharma SAS None
10.2 Place of incorporation or France N/A
registration
10.3 Consideration for acquisition or $12,585,652 satisfied N/A
disposal through the issue of shares
10.4 Total net assets $12,585,652 N/A
10.5 Nature of business Radiopharmaceutical R&D N/A
and commercialisation
  • See chapter 19 for defined terms 1 September 2016

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Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

Compliance statement

  • 1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.

  • 2 This statement gives a true and fair view of the matters disclosed.

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Sign here: .................. .......................................... Date: 31 October 2018 ~~(Director~~ /Company secretary)

Print name: Melanie Farris

Notes

  1. The quarterly report provides a basis for informing the market how the entity’s activities have been financed for the past quarter and the effect on its cash position. An entity that wishes to disclose additional information is encouraged to do so, in a note or notes included in or attached to this report.

  2. If this quarterly report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.

  3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity.

  4. See chapter 19 for defined terms 1 September 2016

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