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Telix Pharmaceuticals Ltd — Interim / Quarterly Report 2019
Apr 28, 2019
31324_rns_2019-04-28_a6bb1a72-6c69-42fa-8b7f-5bc1ac44c264.pdf
Interim / Quarterly Report
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Quarterly Cashflow Statement: March 2019 Quarter (Q1)
Melbourne (Australia) – 29[th] April 2019 . 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 “molecularlytargeted radiation” (MTR), today releases its Appendix 4C for the March 2019 quarter.
The Company held cash reserves of $17.683 million at the end of March, consistent with forecast. Cash outflows relating to operating expenses were $8.130 million, with total spend on direct R&D (clinical) activities at $5.193 million. Q1 was an expenditure-intensive quarter due to front-loaded costs related to the ZIRCON (renal cancer imaging Phase III trial) and IPAX-1 (glioblastoma therapy Phase I/II trial).
Early Revenue Generation
Following a December launch of the illumet[TM ] prostate imaging kit (as an investigational product), global sales totalled $0.702 million for the quarter. Approximately 70% of revenue was from European sales under “magisterial” (compassionate) use via distribution partners.
The US sales pipeline continues to grow both from direct sales to clinical sites using the product under an investigational new drug (IND) application and support of third-party clinical trials (i.e. Endocyte/Novartis). With payment terms typically 60 days on purchase orders, the proportional impact of US sales is expected to increase in Q2. US-based scale-up production of illumet[TM] will be completed in Q2 in order to fulfil a current order backlog of ~1,200 kits.
Commercially significant activities during the quarter included:
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Independent review of clinical data and acceleration of prostate cancer therapy program : completion of a Telix-initiated independent analysis of Phase II clinical data has informed the basis of a Phase III trial design in a well-defined patient population, potentially enabling Telix to significantly accelerate its prostate cancer therapy program.
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Expansion of prostate imaging product pipeline: in addition to the commercialisation of the illumet[TM] PET prostate imaging kit in US and European markets, Telix concluded the in-licensing of[99m] Tc-PSMA technology from the Mexican National Institute for Nuclear Research (ININ). This very promising technology, with excellent clinical data, will enable Telix to offer a similar prostate imaging solution for use with SPECT imaging. PET imaging is commonly used in the US/EU but SPECT (single-photon imaging) is an imaging approach and radiopharmaceutical supply chain that is far more accessible in MENA, Latin America and Asia enabling Telix to address the prostate cancer imaging needs of approximately 12 million men that do not have access to PET.
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Appointment of Gabriele Liberatore and Group COO: Dr. Liberatore brings 20+ years of experience in senior business development and R&D management positions including CSL Limited, Deloitte (Australia), Swisse Wellness and the PACT Group. With the rapid international expansion of Telix over the past 12 months, including the acquisition of ANMI SA and Atlab SAS, this is a timely appointment.
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Completion of manufacturing of TLX250 (renal cancer therapy) clinical material: the manufacturing and release of the TLX250 drug conjugate was the final major operational step to enable the commencement of further clinical trials in patients with metastatic
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kidney cancer. Trials are expected to commence in the US mid-2019 (subject to FDA approval).
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Submission of claim for R&D tax incentive rebate : a revised $9.271 million (inclusive of overseas R&D/clinical expenditure) for eligible R&D activities undertaken in the year ended 31 December 2018. This rebate is expected to be received in May.
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Manufacture of VisAct® ImmunoPET tracer to standard for clinical use: VisAct® is a PET imaging tracer used to image the trafficking of immune cells in the body. Telix has invested in the clinical availability of VisAct® in order to optimially combine MTR therapeutics with immuno-oncology drugs, particularly for TLX250 (renal cancer) therapy. Telix intends to use VisAct® to image immune responses to determine how to best cycle combination therapies to maximum patient benefit.
An Appendix 4C accompanies this announcement.
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
Telix Investor Relations
Dr. Christian Behrenbruch Lisa Wilson Telix Pharmaceuticals Limited In-Site Communications CEO Tel: +1 212 452 2793 Email: [email protected] 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 | March 2019 |
| Consolidated statement of cash flows | Consolidated statement of cash flows | Current quarter | Year to date |
|---|---|---|---|
| $A’000 | (12 months) | ||
| $A’000 | |||
| 1. | Cash flows from operating activities | ||
| 1.1 | Receipts from customers | 702 | 702 |
| 1.2 | Payments for | ||
| (a) research and development including | |||
| manufacturing costs | (5,193) | (5,193) | |
| (b) product manufacturing and operating | (711) | (711) | |
| costs | |||
| (c) advertising and marketing | (100) | (100) | |
| (d) leased assets | - | - | |
| (e) staff costs | (1,437) | (1,437) | |
| (f) administration and corporate costs |
(689) | (689) | |
| 1.3 | Dividends received (see note 3) | - | - |
| 1.4 | Interest received | 53 | 53 |
| 1.5 | Interest and other costs of finance paid | - | - |
| 1.6 | Income taxes paid | - | - |
| 1.7 | Government grants and tax incentives | - | - |
| 1.8 | Other (provide details if material) | - | - |
| 1.9 | Net cash from / (used in) operating | (7,375) | (7,375) |
| activities | |||
| 2. | Cash flows from investing activities | ||
| 2.1 | Payments to acquire: | ||
| (a) property, plant and equipment | (27) | (27) | |
| (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 | (12 months) | ||
| $A’000 | |||
| (d) intellectual property | (176) | (176) | |
| (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 | (203) | (203) |
| 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 | (88) | (88) |
| 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 | (88) | (88) |
| activities | |||
| 4. | Net increase / (decrease) in cash and | ||
| cash equivalents for the period | |||
| 4.1 | Cash and cash equivalents at beginning of | 25,668 | 25,668 |
| quarter/year to date | |||
| 4.2 | Net cash from / (used in) operating | (7,375) | (7,375) |
| activities (item 1.9 above) | |||
| 4.3 | Net cash from / (used in) investing activities | (203) | (203) |
| (item 2.6 above) | |||
| 4.4 | Net cash from / (used in) financing activities | (88) | (88) |
| (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 | (12 months) | ||
| $A’000 | |||
| 4.5 | Effect of movement in exchange rates on | (319) | (319) |
| cash held | |||
| 4.6 | Cash and cash equivalents at end of | 17,683 | 17,683 |
| 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 | 14,571 | 18,585 |
| 5.2 | Call deposits | 3,111 | 7,083 |
| 5.3 | Bank overdrafts | - | - |
| 5.4 | Other (provide details) | - | - |
| 5.5 | Cash and cash equivalents at end of | 17,683 | 25,668 |
| 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 | 184 |
| 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 | 396 |
| 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 |
Organisational and Scientific Services provided by related party
- 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 | 5,241 | |
| 9.2 | Product manufacturing and operating costs | - | |
| 9.3 | Advertising and marketing | 25 | |
| 9.4 | Leased assets | - | |
| 9.5 | Staff costs | 1,575 | |
| 9.6 | Administration and corporate costs | 634 | |
| 9.7 | Other (provide details if material) | - | |
| 9.8 | Total estimated cash outflows | 7,475 |
| 10. | Acquisitions and disposals of | Acquisitions | Disposals |
|---|---|---|---|
| business entities | |||
| (items 2.1(b) and 2.2(b) above) | |||
| 10.1 | Name of entity | None | None |
| 10.2 | Place of incorporation or | N/A | N/A |
| registration | |||
| 10.3 | Consideration for acquisition or | N/A | N/A |
| disposal | |||
| 10.4 | Total net assets | N/A | N/A |
| 10.5 | Nature of business | N/A | N/A |
- 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
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1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.
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2 This statement gives a true and fair view of the matters disclosed.
Sign here:
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............................................................ ~~(Director~~ /Company secretary)
Date: 29[th] April 2019
Print name: Melanie Farris
Notes
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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.
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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.
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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.
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See chapter 19 for defined terms 1 September 2016
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