AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Heidelberg Pharma AG

Quarterly Report Apr 11, 2019

201_10-q_2019-04-11_8dead639-e40a-4951-8675-8bea4d867ed4.pdf

Quarterly Report

Open in Viewer

Opens in native device viewer

Heidelberg Pharma AG: Interim Management Statement on the First Three Months of 2019

  • Partner Link Health receives approval to conduct clinical trials with MESUPRON® in China
  • Poster presentation at the AACR Annual Meeting 2019
  • Financials have developed in line with planning

Ladenburg, Germany, 11 April 2019 – Heidelberg Pharma AG (FSE: WL6) today reported on the first three months of fiscal year 2019 (1 December 2018 – 28 February 2019) and the Group's financial figures.

Important operational achievements

  • IND approval and milestone payment from Link Health: In January 2019, Heidelberg Pharma announced that the IND application for a Phase I and II trial with MESUPRON® was approved at the end of 2018. Details of the planned trials are not yet available as the Chinese regulatory authorities have changed the trial regulations, as a result of which Link Health can revise the clinical development plan for MESUPRON®. There is now a chance that a Phase II trial can begin immediately based on previous data from the USA and Europe. A milestone payment became payable to Heidelberg Pharma when the trial was granted approval in principle. In this context, EUR 421 thousand was recognized in profit or loss.
  • Manufacturing of Amanitin according to Good Manufacturing Practice: Based on the established GMP production for the Amanitin-linker developed by Heidelberg Pharma for its Antibody Targeted Amanitin Conjugates (ATACs), Heidelberg Pharma will not only be able to supply license partners on a laboratory scale in the future, but will also be able to offer supplies in GMP quality. The conceptual coordination with our GMP manufacturer Carbogen and our partner Magenta was largely completed in recent weeks.

Events after the reporting period

Poster presentation at the AACR Annual Meeting 2019: Heidelberg Pharma presented a poster on preclinical data on an ATAC that is aimed against the breast cancer antigen HER2 at the Annual Meeting of the American Association of Cancer Research (AACR) in Atlanta in March. These data from an experimental case study show that the HER2-ATAC has the potential to efficiently target tumors with low HER2 expression, which are frequent in triple negative breast cancer. Further, the data show that tumor cells with aggressive progression associated with 17p deletion are particularly susceptible to this treatment.

Results of operations, financial position and net assets

The Heidelberg Pharma Group – as of the reporting date comprising Heidelberg Pharma AG and subsidiary Heidelberg Pharma Research GmbH – reports consolidated figures. The reporting period referred to below concerns the period from 1 December 2018 to 28 February 2019 (first quarter 2019).

In the first three months of fiscal year 2019, the Group generated sales revenue and income totaling EUR 1.3 million (previous year: EUR 0.7 million). This figure includes significantly increased sales revenue of EUR 1.1 million (previous year: EUR 0.6 million), which are attributable to the ATAC

technology (EUR 0.4 million), the service business (EUR 0.3 million) and the out-licensing of MESUPRON® (EUR 0.4 million).

At EUR 0.2 million, other income increased compared to the previous year (EUR 0.1 million). It primarily consists of passing on patent costs and of the reversal of unutilized accrued liabilities and provisions.

Operating expenses including depreciation and amortization amounted to EUR 4.4 million in the reporting period (previous year: EUR 3.1 million). Cost of sales for customer-specific research amounted to EUR 0.7 million (previous year: EUR 0.4 million). Research and development (R&D) costs of EUR 3.0 million were up EUR 0.9 million as planned compared to the prior-year period (EUR 2.1 million) due to an increase in costs related to preparations for external GMP production (Good Manufacturing Practice) incurred by Heidelberg Pharma Research GmbH. At 67% of operating expenses, R&D was by far the largest cost item as expected. Administrative costs in the first quarter of 2019 increased to EUR 0.7 million compared to the prior-year period (EUR 0.6 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 which mainly comprise staff, travel and consulting costs, remained constant at EUR 0.03 million in the current reporting period (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 3.1 million, as planned (previous year: EUR 2.4 million). Basic earnings per share based on the weighted average number of shares issued during the reporting period deteriorated from EUR -0.09 in the previous year to EUR -0.11 in the past quarter due to the higher loss.

Total assets as of 28 February 2019 amounted to EUR 28.3 million compared to the 30 November 2018 reporting date (EUR 31.2 million) due to a decrease in cash and cash equivalents. At EUR 22.9 million, equity was also down compared to the end of fiscal year 2018 (EUR 25.9 million). This corresponds to an equity ratio of 80.9% (30 November 2018: 83.0%). The exercise of convertible bonds (mandatory convertible bonds) in the first quarter of 2019 resulted in further 10,552 new no par value shares that increased the share capital of Heidelberg Pharma AG from EUR 28,133,308 to EUR 28,143,860 divided into 28,143,860 no par value bearer shares.

No corporate actions were implemented during the reporting period.

Cash and cash equivalents as of the end of the first quarter amounted to EUR 16.1 million (30 November 2018: EUR 19.4 million). This represents an average monthly cash outflow of EUR 1.12 million in the first quarter of the fiscal year (previous year: EUR 1.08 million).

Financial outlook for 2019

Financial guidance is confirmed compared to that provided on 21 March 2019. The Heidelberg Pharma Group expects to generate between EUR 5.0 million and EUR 7.0 million in sales revenue and other income (2018: EUR 4.4 million) for the 2019 fiscal year. This guidance takes into account potential cash inflows from new licensing activities. According to current plans, operating expenses should be in the range of EUR 14.0 million to EUR 18.0 million (2018: EUR 16.0 million). Earnings before interest and taxes (EBIT) for the 2019 fiscal year are projected to be between EUR -8.0 million and EUR -12.0 million (2018: EUR -11.7 million).

Heidelberg Pharma expects to require funds of EUR 10.0 million to EUR 14.0 million in 2019. Monthly cash use should be in the range of EUR 0.9 million to EUR 1.2 million. Based on current planning, the Company's financing is secured until mid of 2020.

Heidelberg Pharma will not hold a conference call on this interim management statement. The complete figures for the interim financial statement can be downloaded at www.heidelberg-pharma.com > Press+Investors > Announcements > Financial Reports > Interim Management Statement on the first three months of 2019.

Key figures for the Heidelberg Pharma Group (unaudited)

1
Q1 2019
1
Q1 2018
In EUR'000 EUR'000. EUR '000.
Earnings
Sales revenue 1,071 592
Other income 245 124
Operating expenses (4,400) (3,130)
of which research and development costs (2,969) (2,075)
Operating result (3,084) (2,414)
Earnings before tax (3,084) (2,414)
Net loss for the period (3,084) (2,414)
Earnings per share in EUR
(basic)
(0.09) (0.11)
Balance sheet as of the end of the period
Total assets 28,326 38,064
Cash and cash equivalents 16,069 27,151
Equity 22,916 34,641
Equity ratio2
in %
80.9 91.0
Cash flow statement
Cash flow from operating activities (2,957) (3,087)
Cash flow from investing activities (412) (154)
Cash flow from financing activities 0 0
Employees (number)
Employees as of the end of the period3 66 60
Full-time equivalents as of the end of the period3 60 54

1 The reporting period begins on 1 December and ends on 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 Germany

IR/PR support

MC Services AG Katja Arnold (CIRO) Managing Director & Partner Tel.: +49 89 210 228-40 Cell: +49 160 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 using its proprietary Antibody Targeted Amanitin Conjugate (ATAC) technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. This proprietary technology platform is being applied to develop the Company's proprietary therapeutic ATACs as well as in third-party collaborations to create a variety of ATAC candidates. 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®, while RENCAREX® is available for out-licensing and further development. Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at http://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 position, earnings, achievements, or industry results, to be materially different from any future results, earnings 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 2019 (unaudited)

Consolidated statement of comprehensive income
in EUR Q1 2019 Q1
2018
Sales revenue
Other income
Income
1,070,613
245,465
1,316,078
591,970
123,591
715,561
Cost of sales
Research and development costs
Administrative costs
Other expenses
Operating expenses
(688,557)
(2,968,853)
(707,612)
(34,896)
(4,399,917)
(376,722)
(2,074,697)
(644,454)
(33,838)
(3,129,711)
OPERATING RESULT (3,083,839) (2,414,150)
Finance income
Finance costs
Financial result
0
0
0
0
0
0
EARNINGS BEFORE TAX (3,083,839) (2,414,150)
Income taxes 0 0
NET LOSS FOR THE PERIOD (3,083,839) (2,414,150)
Net currency gain/loss from consolidation 0 0
OTHER COMPREHENSIVE INCOME 0 0
COMPREHENSIVE INCOME (3,083,839) (2,414,150)
Basic earnings per share in EUR (0.11) (0.09)

Consolidated balance sheet

in EUR 28 Feb. 2019
(unaudited)
30 Nov. 2018
(audited)
Property, plant and equipment 2,231,486 1,949,922
Intangible assets 2,822,572 2,800,914
Goodwill 6,111,166 6,111,166
Other non-current assets 41,350 41,350
Non-current assets 11,206,573 10,903,351
Inventories 48,624 177,559
Prepayments 523,925 56,032
Trade receivables 113,904 365,949
Other receivables 363,544 248,734
Cash and cash equivalents 16,069,027 19,440,352
Current assets 17,119,023 20,288,625
TOTAL ASSETS 28,325,597 31,191,977
Subscribed capital 28,143,860 28,133,308
Capital reserve 214,746,530 214,643,257
Accumulated losses (219,974,315) (216,890,476)
Equity 22,916,074 25,886,089
Non-current liabilities 0 0
Trade payables 1,181,403 405,498
Pension obligations 12,101 12,101
Other current liabilities 4,216,018 4,888,288
Current liabilities 5,409,523 5,305,887
TOTAL EQUITY AND LIABILITIES 28,352,597 31,191,977

Consolidated cash flow statement (unaudited)

in EUR Q1 2019 Q1 2018
NET LOSS FOR THE PERIOD (3,083,839) (2,414,150)
Adjustment for items in the statement of
comprehensive income
Stock options 113,824 31,641
Depreciation, amortization and impairment losses 108,989 76,533
Exchange rate effects 2,087 (11,014)
224,900 97,161
Changes in balance sheet items
Inventories 128,934 96,597
Prepayments (467,892) (14,739)
Trade receivables 252,045 124,842
Other receivables (114,811) 66,646
Trade payables 775,905 (864,193)
Other liabilities (672,270) (179,292)
(98,088) (770,138)
Cash flow from operating activities (2,957,027) (3,087,127)
Finance costs paid 0 0
Finance income received 0 0
Net cash flow from operating activities
(2,957,027) (3,087,127)
Cash flow from investing activities
Purchase of property, plant and equipment (378,602) (147,953)
Purchase of intangible assets (33,609) (5,724)
Net cash flow from investing activities (412,211) (153,677)
Net cash flow from financing activities 0 0
Influence of exchange rate effects on cash and cash
equivalents (2,087) 11,014
Net change in cash and cash equivalents (3,371,325) (3,229,790)
Cash and cash equivalents
at beginning of period 19,440,352 30,381,061
at end of period 16,069,027 27,151,271

Consolidated statement of changes in equity (unaudited)

in EUR Shares Subscribed
capital
Capital reserve Accumulated losses Total
Corporate
actions/premium
Measurement
of stock
options
216,121,501 3,668,292
As of 1 December 2017 22,452,570 22,452,570 219,789,793 (205,218,496) 37,023,866
Measurement of stock options
Net loss for the period
("Comprehensive
31,641 31,641
Income") (2,414,150) (2,414,150)
Exercise of mandatory convertible bonds 5,649,964 5,649,964 (5,649,964) 0
Net change in equity (2,382,509)
210,471,537 3,699,933
As of 28 February 2018 28,102,534 28,102,534 214,171,470 (207,632,647) 34,641,357
in EUR Shares Subscribed
capital
Capital reserve Accumulated losses Total
Corporate
actions/premium
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
113,824 113,824
Income") (3,083,839) (3,083,839)
Exercise
of
mandatory
convertible bonds
10,552 10,552 (10,552) 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

Talk to a Data Expert

Have a question? We'll get back to you promptly.