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Heidelberg Pharma AG

Interim / Quarterly Report Apr 23, 2020

201_10-q_2020-04-23_5dadf86a-f96b-43e3-abe4-92f7e984a154.pdf

Interim / Quarterly Report

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Heidelberg Pharma AG: Interim Management Statement on the First Three Months of 2020

  • Licensing partner Magenta announces MGTA-117 as the first ATAC candidate for clinical development
  • Telix receives FDA approval for TLX250-CDx to carry out Phase III clinical trial in the USA
  • MD Anderson Cancer Center and licensee Heidelberg Pharma are granted US patent for diagnosis and treatment of patients with TP53/RNA polymerase II deletion using ATAC technology
  • Heidelberg Pharma is granted European patent for amatoxin conjugates for tumor therapy
  • Heidelberg Pharma AG secures financing commitment of up to EUR 15 million from its main shareholder dievini
  • Financials developed in line with planning

Ladenburg, Germany, 23 April 2020 – Heidelberg Pharma AG (FSE: WL6), a company specializing in Antibody Targeted Amanitin Conjugates (ATACs), today reported on the first three months of fiscal year 2020 (1 December 2019 – 29 February 2020) and the Group's financial figures.

Dr. Jan Schmidt-Brand, CEO and CFO of Heidelberg Pharma AG, commented: "Eventful weeks lie behind us. In times of the coronavirus crisis, high priority is given to measures aimed at protecting employees from infection. Nevertheless, the most important activities at Heidelberg Pharma and at our manufacturers and research service providers have so far been implemented according to plan. Work on our development candidate HDP-101 continues unabated, and our goal still is to complete and submit the data package for the clinical trial in the second half of the year. Our patent portfolio was bolstered by two key basic patents for our ATAC technology granted shortly after the end of the quarter.

We are delighted that our main shareholder dievini has once again expressed its confidence in us by committing to providing another EUR 15 million in funding. Our financials developed in line with planning. Thanks to versatile preclinical and clinical progress made by our partners and in our own activities, Heidelberg Pharma's share price has performed well despite the difficult environment."

Important operational developments and achievements

  • HDP-101 (BCMA-ATAC) development program: Heidelberg Pharma is working hard to complete the preclinical data package and preparations of the clinical trial for HDP-101, a BCMA Antibody Targeted Amanitin Conjugate for treating multiple myeloma. The GLP toxicity study has begun and the specified timelines for GMP production allow for discussion with the FDA and the Paul Ehrlich Institute in the course of the year.
  • Financing commitment by main shareholder dievini: In January 2020, Heidelberg Pharma AG announced that it has secured a financing commitment from its main shareholder dievini Hopp BioTech holding GmbH & Co. KG, Walldorf, Germany, (dievini). dievini will provide the Company with up to EUR 15 million in cash funds. The Executive Management Board and the Supervisory Board of Heidelberg Pharma AG together with

dievini will specify the details of the financing. With this additional commitment and based on current planning, the Company's cash reach is secured until mid-2021.

Partner program update

  • Progress made by licensing partner Magenta: In January 2020, Magenta Therapeutics, Cambridge, MA, USA, (Magenta) (NASDAQ: MGTA) announced ATAC MGTA-117 as a clinical candidate for the targeted preparation of patients (conditioning) for stem cell transplants or gene therapies. Magenta has presented preclinical data from working with Heidelberg Pharma's ATAC technology at various scientific congresses, such as the American Society of Hematology (ASH) annual meeting and the Transplant and Cellular Therapies (TCT) conference, and investor events. Magenta will conduct further preclinical studies and prepare MGTA-117 for clinical development. Magenta plans to present initial clinical data on MGTA-117 in 2021. MGTA-117 is an ATAC that consists of a CD117 antibody and the toxin Amanitin and was developed as part of Magenta's partnership with Heidelberg Pharma.
  • Progress with partner Telix: In 2019, Telix Pharmaceuticals Limited, Melbourne, Australia, (Telix) (ASX: TLX) had launched a Phase III trial (ZIRCON) in Australia and Europe with TLX250-CDx for the imaging of renal cancer using Positron Emission Tomography (PET). In early 2020, the IND for this study was approved in the USA and patient recruitment for the study has started.

Events after the reporting period

  • Partner MD Anderson Cancer Center receives US patent for diagnosis and treatment of patients with TP53/RNA polymerase II deletion: Heidelberg Pharma's partner University of Texas, MD Anderson Cancer Center, Houston, TX, USA, (MD Anderson) was granted a key patent by the US patent office for diagnosis and treatment of select patient groups with TP53/RNA polymerase II deletion. The patent application entitled "Methods Of Treating Cancer Harbouring Hemizygous Loss Of TP53" was submitted with the US patent office by MD Anderson. Heidelberg Pharma holds the exclusive licensing rights to this patent.
  • Heidelberg Pharma is granted European patent for amatoxin conjugates for tumor therapy: In late March, the European Patent Office granted Heidelberg Pharma an important patent for its proprietary ATAC technology for the production of Antibody Targeted Amanitin Conjugates. The patent is based on a patent application entitled "Amatoxin armed therapeutic cell surface binding components designed for tumor therapy" that was submitted by Professor Heinz Faulstich and employees of the German Cancer Research Centre (DKFZ). Heidelberg Pharma exclusively in-licensed the patent in December 2009.
  • Developments at partner RedHill: In March 2020, Heidelberg Pharma's partner RedHill Biopharma Ltd, Tel Aviv, Israel, (RedHill) (Nasdaq: RDHL) announced its plans to trial RHB-107 (upamostat) in combination with another of its investigational drugs, opaganib, in a third arm of an ongoing Phase I/IIa study in advanced cholangiocarcinoma, subject to talks with the FDA. On 20 April 2020, RedHill announced that it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to provide RHB-107 for testing in non-clinical studies for activity against SARS-CoV-2, the virus that causes coronavirus disease (COVID-19).

Results of operations, financial position and net assets

The Heidelberg Pharma Group – as of the reporting date comprising Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH – reports consolidated figures. The reporting period referred to below concerns the period from 1 December 2019 to 29 February 2020 (Q1 2020).

In the first three months of fiscal year 2020, the Group generated sales revenue and income totaling EUR 1.8 million (previous year: EUR 1.3 million). This figure includes higher sales revenue of EUR 1.5 million (previous year: EUR 1.1 million) generated by the ATAC technology (EUR 1.3 million) and the service business (EUR 0.2 million).

At EUR 0.3 million, other income was up on the prior-year figure (EUR 0.2 million). It primarily consisted of the reversal of unutilized accrued liabilities and provisions, and government grants.

Operating expenses including depreciation and amortization totaled EUR 6.3 million in the reporting period (previous year: EUR 4.4 million). Cost of sales amounted to EUR 1.5 million (previous year: EUR 0.7 million). Research and development (R&D) costs of EUR 3.9 million were up EUR 0.9 million compared to the prior-year period (EUR 3.0 million) due to an increase in costs related to external GMP production (Good Manufacturing Practice) incurred by Heidelberg Pharma Research GmbH. At 61% of operating expenses, R&D was the largest cost item. Administrative costs rose to EUR 0.8 million in the first quarter of fiscal year 2020 (Q1 2019: EUR 0.7 million). Among others, this figure includes holding company costs and costs related to the stock market listing. Other expenses for business development, marketing and commercial market supply activities in the current reporting period totaled EUR 0.1 million (previous year: EUR 0.03 million).

The Heidelberg Pharma Group's net loss for the first three months of the fiscal year increased to EUR 4.6 million, as planned (previous year: EUR 3.1 million). Basic earnings per share based on the weighted average number of shares issued during the reporting period fell from EUR -0.11 in the previous year to EUR -0.16 in the reporting quarter as a result of the higher loss.

Total assets as of 29 February 2020 decreased to EUR 19.0 million compared to the 30 November 2019 reporting date (EUR 23.0 million) due to a decrease in cash and cash equivalents. At EUR 11.9 million, equity was also down compared to the end of fiscal year 2019 (EUR 16.3 million). This corresponds to an equity ratio of 62.5% (30 November 2019: 70.9%). No corporate actions were implemented during the reporting period. The share capital of Heidelberg Pharma AG therefore remained steady at EUR 28,209,611, divided into 28,209,611 no par value bearer shares.

Cash and cash equivalents as of the end of the quarter amounted to EUR 4.9 million (30 November 2019: EUR 9.9 million). This represents an average monthly cash outflow of EUR 1.66 million in the first quarter of the fiscal year (previous year: EUR 1.12 million).

Financial outlook for 2020

The Heidelberg Pharma Group confirms its full-year financial guidance issued on 19 March 2020. The Executive Management Board expects the Group to generate between EUR 8.0 million and EUR 10.0 million in sales revenue and other income (2019: EUR 8.0 million) for the 2020 fiscal year. This planning takes into account additional potential cash inflows from new licensing activities. Based on current planning, operating expenses are expected to be in the range of EUR 20.0 million to EUR 24.0 million, higher than in 2019 (EUR 18.1 million). Earnings before interest and taxes (EBIT) for 2020 are expected to be between EUR -11.0 million and EUR -15.0 million (2019: EUR -10.1 million).

Heidelberg Pharma expects to require funds of EUR 11.0 million to EUR 15.0 million in 2020. Monthly cash use should be in the range of EUR 0.9 million to EUR 1.3 million. Based on current planning and factoring in the financing commitment made by dievini, the Company's financing is secured until mid-2021.

Heidelberg Pharma will not host a conference call on this interim management statement. The complete figures for the interim financial statements can be downloaded from http://www.heidelberg-pharma.com/ "Press & Investors > Financial Reports > Interim management statement on the first three months of 2020".

Key figures for the Heidelberg Pharma Group (unaudited)

Q1 20201 Q1 20191
In EUR thsd. EUR thsd. EUR thsd.
Earnings
Sales revenue 1,498 1,071
Other income 267 245
Operating expenses (6,333) (4,400)
of which research and development costs (3,879) (2,969)
Operating result (4,567) (3,084)
Earnings before tax (4,571) (3,084)
Net loss for the period (4,571) (3,084)
Earnings per share in EUR (basic) (0.16) (0.11)
Balance sheet as of the end of the period
Total assets 19,026 28,326
Cash and cash equivalents 4,903 16,069
Equity 11,899 22,916
Equity ratio2
in %
62.5 80.9
Cash flow statement
Cash flow from operating activities (4,636) (2,957)
Cash flow from investing activities (332) (412)
Cash flow from financing activities (24) 0
Employees (number)
Employees as of the end of the period3 77 66
Full-time equivalents as of the end of the period3 72 60

1 The reporting period begins on 1 December and ends on 29/28 February.

2 Equity / total assets

3 Including members of the Executive Management Board Rounding of exact figures may result in differences.

Contact

Heidelberg Pharma AG Corporate Communications Sylvia Wimmer Tel.: +49 89 41 31 38-29 Email: investors[at]hdpharma.com Schriesheimer Str. 101, 68526 Ladenburg

IR/PR support

MC Services AG Katja Arnold (CIRO) Managing Director & Partner Tel.: +49 89 210 228-40 Cell: +49 (0)160 9360 3022 Email: katja.arnold[at]mc-services.eu

About Heidelberg Pharma

Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany. Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies. Its proprietary technology platform is being applied to develop the Company's proprietary therapeutic ATACs as well as in third-party collaborations. The proprietary lead candidate HDP-101 is a BCMA ATAC for multiple myeloma.

The Company has entered into partnerships to further develop and commercialize its clinical assets MESUPRON® and REDECTANE®. Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at www.heidelberg-pharma.com.

This communication contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "will", "should", "future", "potential" or similar expressions or by a general discussion of the Company's strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

Consolidated IFRS interim financial statements of Heidelberg Pharma AG, Ladenburg, Germany, for the first quarter of fiscal year 2020 (unaudited)

Consolidated statement of comprehensive income
iin EUR Q1 2020 Q1 2019
Sales revenue
Other income
Income
1,498,132
267,484
1,765,616
1,070,613
245,465
1,316,078
Cost of sales
Research and development costs
Administrative costs
Other expenses
Operating expenses
(1,507,017)
(3,879,222)
(855,898)
(90,592)
(6,332,729)
(688,557)
(2,968,853)
(707,612)
(34,896)
(4,399,917)
OPERATING RESULT (4,567,113) (3,083,839)
Finance income
Finance costs
Financial result
0
(3,427)
(3,427)
0
0
0
EARNINGS BEFORE TAX (4,570,539) (3,083,839)
Income taxes 0 0
NET LOSS FOR THE PERIOD (4,570,539) (3,083,839)
Net currency gain/loss from consolidation 0 0
OTHER COMPREHENSIVE INCOME 0 0
COMPREHENSIVE INCOME (4,570,539) (3,083,839)
Basic earnings per share in EUR
(undiluted)
(0.16) (0.11)

Consolidated balance sheet

29.02.2020 30.11.2019
in EUR (unaudited) (audited)
Property, plant and equipment 2,728,536 2,426,848
Intangible assets 2,785,944 2,800,732
Goodwill 6,111,166 6,111,166
Equity investments accounted for using the equity
method
12,599 12,599
Other non-current assets 44,900 44,900
Non-current assets 11,683,144 11,396,244
Inventories 843,221 237,702
Prepayments 175,454 63,888
Trade receivables 500,792 1,230,258
Other receivables 920,685 178,682
Cash and cash equivalents 4,903,061 9,883,592
Current assets 7,343,212 11,594,122
TOTAL ASSETS 19,026,356 22,990,366
Subscribed capital 28,209,611 28,209,611
Capital reserve 215,444,905 215,268,448
Accumulated losses (231,755,178) (227,184,639)
Equity 11,899,337 16,293,420
Lease liabilities
(non-current)
163,210 0
Contract liabilities
(non-current)
84,702 235,247
Non-current liabilities 247,913 235,247
Trade payables 1,782,544 1,011,708
Lease liabilities
(current)
94,253 0
Contract liabilities
(current)
1,612,163 1,938,064
Other current liabilities 3,390,148 3,511,926
Current liabilities 6,879,107 6,461,699
TOTAL EQUITY AND LIABILITIES 19,026,356 22,990,366

Consolidated cash flow statement (unaudited)

in EUR Q1 2020 Q1 2019
NET LOSS FOR THE PERIOD (4,570,539) (3,083,839)
Adjustment for items in the statement of
comprehensive income
Stock options 176,457 113,824
Depreciation, amortization and impairment losses 124,134 108,989
Exchange rate effects (12,258) 2,087
Finance costs 3,427 0
291,759 224,900
Changes in balance sheet items
Inventories (605,520) 128,934
Prepayments (111,566) (467,892)
Trade receivables 729,466 252,045
Other receivables (742,003) (114,811)
Other non-current assets 770,835 775,905
Lease liabilities 257,463 0
Contract liabilities (476,447) 0
Other current liabilities (176,343) (672,270)
(354,113) (98,088)
Cash flow from operating activities (4,632,893) (2,957,027)
Finance costs paid (3,427) 0
Finance income received 0 0
Net cash flow from operating activities (4,636,320) (2,957,027)
Cash flow from investing activities
Purchase of property, plant and equipment (329,474) (378,602)
Purchase of intangible assets (2,780) (33,609)
Net cash flow from investing activities (332,254) (412,211)
Net cash flow from financing activities
Principal elements of lease payments (24,215) 0
Net change in cash and cash equivalents (24,215) 0
Influence of exchange rate effects on cash and cash
equivalents 12,258 (2,087)
Net change in cash and cash equivalents (4,980,531) (3,371,325)
Cash and cash equivalents
at beginning of period 9,883,592 19,440,352
at end of period 4,903,061 16,069,027

Consolidated statement of changes in equity (unaudited)

in EUR Shares Subscribed
capital
Capital reserve Accumulated
losses
Total
Corporate
actions/premium
others
Measurement
of stock
options
210,440,763 4,202,495
As of 1 December 2018 28,133,308 28,133,308 214,643,257 (216,890,476) 25,886,089
Measurement of stock options
Net loss for the period
("Comprehensive Income")
Exercise of mandatory convertible bonds
10,552 10,552 (10,552) 113,824 (3,083,839) 113,824
(3,083,839)
0
Net change in equity (2,970,015)
210,430,211 4,316,319
As of 28 February 2019 28,143,860 28,143,860 214,746,530 (219,974,315) 22,916,074
in EUR Shares Subscribed
capital
Capital reserve Accumulated
losses
Total
Corporate
actions/premium
others
Measurement
of stock
options
210,364,460 4,903,988
As of 1 December 2019 28,209,611 28,209,611 215,268,448 (227,184,639) 16,293,420
Measurement of stock options
Net loss for the period
("Comprehensive Income")
Exercise
of mandatory convertible bonds
Net change in equity
176,457 (4,570,539) 176,457
(4,570,539)
(4,394,083)
210,364,460 5,080,445
As of 29
February
2020
28,209,611 28,209,611 215,444,905 (231,755,178) 11,899,337

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