UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the date of September 23, 2020

 

Commission File Number 001-39124

 

Centogene N.V.
(Translation of registrant’s name into English)

 

Am Strande 7
18055 Rostock

Germany
(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F..x.. Form 40-F.o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

 

 

 


 

Centogene N.V.

 

On September 23, 2020, Centogene N.V. (the “Company”) issued a press release reporting its financial results for the First Half 2020. A copy of the press release is attached hereto as Exhibit 99.1.

 

Attached hereto as Exhibit 99.2 and 99.3 are the unaudited interim condensed consolidated financial statements of the Company as of December 31, 2019 and June 30, 2020 and for the three and six months ended June 30, 2019 and 2020 and the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the three and six months ended June 30, 2019 and 2020, respectively.

 

All exhibits attached hereto are incorporated by reference herein.

 

Exhibits 99.2 and 99.3 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form S-8 (Registration Number 333-234551) of the Company and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

Exhibit 99.1 to this Report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the U.S. Securities Act of 1933, as amended, or the Exchange Act.

 

2


 

Signatures

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

CENTOGENE N.V.

 

 

 

 

Date: September 23, 2020

 

 

 

 

 

 

By:

/s/ Richard Stoffelen

 

 

Name:

Richard Stoffelen

 

 

Title:

Chief Financial Officer

 

3


 

Exhibit Index

 

Exhibit

 

Description of Exhibit

 

 

 

99.1

 

Press Release dated September 23, 2020

99.2

 

Unaudited Condensed Consolidated Interim Financial Statements as of December 31, 2019 and June 30, 2020 and for the Three and Six Months ended June 30, 2019 and 2020

99.3

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Six Months ended June 30, 2019 and 2020

 

4


Exhibit 99.1

 

CENTOGENE Reports First Half 2020 Financial Results

 

CAMBRIDGE, Mass., and ROSTOCK & BERLIN, Germany, September 23, 2020 (Globe Newswire) — Centogene N.V. (Nasdaq: CNTG) (“CENTOGENE” or the “Company”),  a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today provided an update on its corporate progress and reported its financial results for the three and six months ended June 30, 2020.

 

·                  Cautiously anticipate 2020 full year revenues to be within the range of €60 and €65 million

 

·                  H1 2020 revenues decreased slightly by 0.4% compared to H1 2019 and recovery in core businesses with increases in test requests and new pharmaceutical collaborations

 

·                  R&D collaborations with Molecular Health and Evotec further evidenced the value of CENTOGENE’s global proprietary rare disease platform, which, as of August 31, 2020, included real-world data repository with over 3.6 billion weighted data points from approximately 570,000 patients representing 120 different countries

 

·                  Comprehensive high-quality COVID-19 testing solutions available at major travel hubs in Germany, nursing homes, and educational institutions as well as via online marketplace, with close to 270,000 test requests received up to the end of August 2020

 

·                  CentoFast-SARS-CoV-2 RT-PCR test received U.S. Food and Drug Administration (“FDA”) Emergency Use Authorization (“EUA”)

 

·                  Completed follow-on equity offering in July 2020 with proceeds, net of underwriting discounts and commissions, of €24 million

 

Prof. Arndt Rolfs, CEO of CENTOGENE, said, “During the first half of 2020, we have shown resilience while facing global pandemic headwinds, and we believe we have weathered the worst of this unprecedented situation. Our core business in the rare disease space regained momentum as we continued to expand our COVID-19 efforts and address the urgent need for reliable testing solutions. Ultimately, this underlines the return to a “new normal” for patients, physicians, and orphan drug developers.”

 

Prof. Arndt Rolfs continued, “Supported by recovering diagnostic volumes, well-established pharma partnerships, and further expansion of our COVID-19 testing efforts, we remain confident in our outlook through the end of the year as we continue to deliver on our life-long commitment to support patients around the world.”

 

Unwavering Commitment to Patients Drives Recovery

 

During Q2 2020, the Company has been able to operate at full capacity and keep its commitment to supporting patients around the world. By rapidly responding to the novel coronavirus in Q1 2020 and deploying a series of testing initiatives to contribute to the important needs in diagnosis and disease surveillance, CENTOGENE has been able to minimize the disruption to its core businesses and maintain a solid financial and operational status.  As the global community transitioning to a new normal, the number of test requests in the core diagnostics and pharmaceutical segments has gradually recovered. The Company’s pharmaceutical segment has also regained momentum with clinical trials of our pharmaceutical partners slowly resuming and further collaborations have been concluded.

 


 

The Company has been continuing to expand its medical and genetic knowledge of rare genetic diseases.  With CENTOGENE’s expertise in rare diseases and biomarker discovery, as well as the large volume of datasets in its global proprietary rare disease platform, the Company entered into R&D collaborations its strategic partners, Molecular Health and Evotec, aiming to shorten the diagnostics odyssey of rare disease patients and accelerate the development of new orphan drugs.

 

Expanding COVID-19 Testing Initiatives

 

Since the commencement of its COVID-19 testing in March 2020, CENTOGENE has expanded the COVID-19 test offering from employees and essential workers in Rostock, Germany, to nursing homes and high school students throughout Germany in May 2020.  In June 2020, CENTOGENE announced a partnership with Lufthansa and Fraport, the operator of Frankfurt airport, to open the first COVID-19 walk-in test center at Frankfurt Airport, providing on-site testing for travelers and the general public.  Subsequent to June 2020, additional test centers were set up at Munich and Nuremberg Central Stations offering COVID-19 tests to travelers returning to Germany from “high risk regions” as defined by the Robert Koch Institute (RKI), the public health agency which compiles the COVID-19 statistics in Germany.   In August 2020, CENTOGENE announced the opening of a further walk-in testing facility at Hamburg Airport offering its COVID-19 testing to passengers departing from Hamburg, and returning to Hamburg from non-high risk countries as well as the general public.

 

In addition, the Company offers its COVID-19 testing to the community through collaborations with the state government of Mecklenburg-Western Pomerania, educational institutions and other companies, as well as via the online marketplace.

 

The Company received over 70,050 COVID-19 test requests in the six months ended June 30, 2020, and approximately 270,000 COVID-19 test requests up to August 31, 2020, on a cumulative basis, of which 44,630 test requests were provided free of charge to our employees, the community and for research and development purposes. The graph below shows the number of  COVID-19 test requests received from the commencement of the testing in March 2020 to August 31, 2020.

 

GRAPHIC

 

*Test requests for COVID-19 for March to May 2020 are aggregated and shown in one column, representing the test requests before walk-in testing centers were established

 


 

CENTOGENE offers a comprehensive and high quality COVID-19 testing solution to the community.   This includes the RT-PCR test, which received EUAs from the FDA; a fully validated sample collection kit, CentoSwab™, which can either be used by healthcare professionals or self-administered by individuals; a secured digital platform, including Corona-App and test portal, which followed stringent data privacy measures in compliance with the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA), allowing seamless registration and result notification.

 


 

Six Months Ended June 30, 2020 and Q2 2020 Financial Highlights

 

Cash and Cash Equivalents

 

Cash and cash equivalents as of June 30, 2020 were €17.4 million, compared to €41.1 million as of December 31, 2019.

 

In July 2020, the Company completed a follow-on public offering of 3,500,000 common shares (“Follow-on Offering”), consisting of 2,000,000 common shares offered by the Company and 1,500,000 common shares offered by selling shareholders at a price to the public of $14.00 per common share (i.e. €12.71 per share).  Aggregate offering proceeds to the Company, net of underwriting discounts and commissions, amounted to €24 million.

 

Revenue

 

Our revenue is principally derived from the provision of pharmaceutical solutions and diagnostic tests enabled by our knowledge and interpretation-based platform.

 

Revenue for the three months ended June 30, 2020 was €9.7 million, representing a decrease of 13.3% as compared to the three months ended June 30, 2019.  Our pharmaceutical and diagnostics segments contributed 40.5% and 59.5%, respectively, of our total revenues for the three months ended June 30, 2020, as compared to 40.8% and 59.2%, respectively, of our total revenues for the three months ended June 30, 2019.

 

Revenue from our pharmaceutical segment was €3.9 million for the three months ended June 30, 2020, a decrease of 13.7%, from €4.6 million for the same period in 2019.  Revenue from our diagnostics segment, including revenue from COVID-19 tests and sales of CentoSwab™ of €2.1 million, was €5.8 million for the three months ended June 30, 2020, a decrease of 12.9%, from €6.6 million for the same period in 2019.

 

Revenue for the six months ended June 30, 2020 was €21.8 million, a decrease of 0.4% from €21.9 million for the six months ended June 30, 2019.  Our pharmaceutical and diagnostics segments contributed 38.9% and 61.1%, respectively, of our total revenues for the six months ended June 30, 2020, as compared to 39.7% and 60.3%, respectively, of our total revenues for the six months ended June 30, 2019.

 

Revenue from our pharmaceutical segment was €8.5 million for the six months ended June 30, 2020, a decrease of 2.4%, from €8.7 million for the same period in 2019.  Revenue from our diagnostics segment was €13.3 million for the six months ended June 30, 2020, an increase of 0.8%, from €13.2 million for the same period in 2019.  Revenue from COVID-19 tests and sales of CentoSwab™ for the six months ended June 30, 2020 was €2.1 million and was included in diagnostics segment.

 

The decrease in revenues from Pharmaceutical and Diagnostics segments in the three and six months ended June 30, 2020 is mainly caused by decrease in our sample volume related to our routine diagnostics business and pharmaceutical collaborations with fee per sample structure.

 


 

The graph below shows the number of test requests for the diagnostics segment (excluding COVID-19 tests) and pharmaceutical segment, as well as the number of test requests received for our internal research projects during the three and six months ended June 30, 2019 and 2020.

 

 

*The testing expenses relating to requests received for our internal research projects were included in Corporate as they did not generate any revenue and cannot be allocated to either of our two business segments.

 

Pharmaceutical segment

 

Our pharmaceutical segment provides a variety of services to our pharmaceutical partners, including target discovery, early patient recruitment and identification, epidemiological and patient population sizing insights, biomarker discovery and patient monitoring and follow-up.  Our information platforms, our access to rare diseases patients and their biomaterials, and our ability to develop proprietary technologies including biomarkers enable us to provide services to our pharmaceutical partners in all phases of the drug development process as well as post commercialization.

 

In particular, with the capability to collaborate with our pharmaceutical partners in the early stages of drug development, puts us in a position to provide more support to the development process and increases our potential to secure further collaborations for the same drugs.

 

Revenues in our pharmaceutical segment are generated primarily from collaboration agreements with our pharmaceutical partners, which are structured on a fee per sample basis, milestone basis, fixed fee basis, royalty basis or a combination of these.

 

As of June 30, 2020, we collaborated with 41 pharmaceutical partners, as compared to 35 pharmaceutical partners as of June 30, 2019.  We had 63 active/completed collaborations in the six months ended June 30, 2020, as compared to 60 collaboration in the six months ended June 30, 2019.

 


 

The graphs below show our revenues for the three and six months ended June 30, 2020 and 2019 resulting from our collaborations with our pharmaceutical partners, split between drug development stages, as well as between different fee structures.

 

 

Revenues from our collaborations which are structured on a fixed fee basis, represented 63.0% and 60.2% of our total revenues for the three and six months ended June 30, 2020, as compared to 59.1% and 57.6% for the three and six months ended June 30, 2019.  These revenues, given the fee structure, provide us with stable revenues and cashflow from the pharmaceutical segment.

 

As new and existing clinical trials were slowed down or put on hold, the COVID-19 pandemic had a more significant impact on our collaborations structured on a fee per sample basis.  Revenues from fee per sample collaborations were €0.4 million and €1.1 million respectively, for the three and six months ended June 30, 2020, decreased by 39.8% and 15.7%, respectively, as compared to the same periods in 2019.  Revenues from the fee per sample collaborations represented 9.7% and 12.5% of our total revenues from the pharmaceutical segment for the three and six months ended June 30, 2020, decreased by 4.2 percentage points and 2.0 percentage points, respectively, as compared to the same periods in 2019.

 

Biomarkers are key in orphan drug development, as they can be used to support a diagnosis, demonstrate the efficacy of a treatment and to monitor the progress of rare disease patients. Biomarkers can also be used to enhance treatment solutions and guide dose titration. As of June 30, 2020, we have over 60 biomarker programs, with over 25 biomarker programs (covering more than 22 diseases) having completed the first validation with mass spectrometry. Out of these biomarker programs, 33 biomarkers were used in connection with our active pharmaceutical collaborations as of June 30, 2020, as compared to 30 as of June 30, 2019. Since early 2020, we also started to pursue a metabolomics approach for establishing a biomarker discovery pipeline for rare hereditary disease. Our new approach includes a tandem mass spectrometry (ion mobility quadrupole time-of-flight mass spectrometry) methodology and artificial intelligence and combined with the large volume of datasets in our global rare disease platform, has proven successful in the identification of new biomarkers.

 


 

Diagnostics segment

 

Our diagnostics segment provides targeted genetic sequencing and diagnostics services to patients through our distribution partners or our clients, who are typically physicians, labs or hospitals.  The revenues for the diagnostics segment are recognized over time by reference to the percentage of completion of the service on the reporting date, assessed on the basis of the work rendered.

 

During the three and six months ended June 30, 2020, we have experienced significant decreases in tests requests received for our primary rare diseases testing products (i.e., standard genetic testing including single gene, CNV and mutation quantification products, panel sequencing, whole exome sequencing (‘‘WES’’) and whole genome sequencing (‘‘WGS’’), as well as non-invasive pre-natal testing (‘‘NIPT’’) and biochemistry) due to the COVID-19 pandemic.

 

The graphs below show test requests and revenues split between our primary rare disease testing products for the three and six months ended June 30, 2020 and 2019:

 

 

 

 

 

 

 

Number of test requests received for our primary rare disease testing products in the three and six months ended June 30, 2020 decreased by 45.7% and 22.8% respectively, as compared to the same periods in 2019.

 

In particular, the decreases in test requests for our NIPT (non-core product) were 55.0% and 55.5%, respectively, for the three and six months ended June 30, 2020 as compared to the same periods ended June 30, 2019, reflecting our strategy of moving towards testing products that provide larger quantity of data such as WES and WGS.

 

Total number of WES and WGS test requests received in the diagnostics segment for the three and six months ended June 30, 2020 represented 29.1% and 32.8%, respectively, of total primary test requests for the periods, which amounts to an increase of 5.9 percentage points and 10.8 percentage points, respectively, as compared to the three and six months ended June 30, 2019.  In addition, total number of WES and WGS test requests received for the six months ended June 30, 2020 increased by 15.5% as compared to the same periods ended June 30, 2019.

 

We anticipate the proportion of WES and WGS as a percentage of total test requests in the future will continue to increase. The data and biomaterials collected through our diagnostics services,  allow us to continue to grow our global biorepository and our rare disease platform repository.

 


 

Research and development expenses (“R&D”)

 

Our R&D expenses increased by 29.6%  to €3.1 million for the three months ended June 30, 2020, and increased by 41.1% to €5.8 million for the six months ended June 30, 2020, as compared to the prior year periods.  The increase is primarily attributable to expenses associated with the expansion of our proprietary information platform, as well as to the development of new products and solutions.

 

General administrative expenses (“G&A”)

 

Our G&A expenses increased by 36.4%, to €7.7 million for the three months ended June 30, 2020, and by 35.0%, to €15.7 million for the six months ended June 30, 2020, as compared to the prior year periods.

 

The increases were principally due to an increase in personnel costs and operating expenses as a result of the expansion of our business. The increase was also due to costs of operating as a public company, such as additional legal, accounting, corporate governance and investor relations expenses, and higher directors’ and officers’ insurance premiums.

 

General administrative expenses for the three and six months ended June 30, 2020 also included €0.3 million expenses related to our free of charge COVID-19 tests, as well as legal and consulting expenses of €0.2 million incurred in relation to our Follow-on Offering completed in July 2020.

 

Other operating expenses

 

We have taken into consideration the impact of the COVID-19 pandemic on the global economy and the unforeseeable potential magnitude of the ultimate disruptions to different businesses when assessing our credit risk, in particular regarding the MENA region for the diagnostic segment as it represents the majority of that segment’s revenue. Such assessment resulted in additional credit losses of €0.5 million and  €1.7 million for the three and six months ended June 30, 2020, respectively. Credit losses for the three and six months ended June 30, 2019 amounted to €0.2 million and €0.5 million, respectively.

 

Comprehensive loss attributable to equity holders

 

The comprehensive loss attributable to equity holders for the three months ended June 30, 2020 was €10.4 million or €0.52 per share, as compared to €6.2 million or €0.39 per share for the prior year period.

 

The comprehensive loss attributable to equity holders for the six months ended June 30, 2020 was €19.0 million or €0.95 per share, as compared to €11.4 million or €0.72 per share for the prior year period.

 

Basic and diluted loss per share is calculated by dividing loss for the period attributable to equity holders of the Group by the weighted average number of shares outstanding of 19,861,340 during the three and six months ended June 30, 2020, and 15,861,340 during the three and six months ended June 30, 2019.

 


 

Financial Outlook

 

The COVID-19 pandemic outbreak poses unprecedented challenges for all businesses, in particular, for healthcare systems across the globe.   CENTOGENE has shown resilience in the first half of 2020 by taking a series of measures to minimize the disruptions to the business and operations. The negative impact on the core businesses in Q2 2020 was partially offset by revenues resulting from our COVID-19 tests.   Since July 2020, the Company has seen the core business in the rare disease space regain momentum, evidenced by the increase in sample volume and new collaborations with pharmaceutical partners.  In addition, the follow-on equity offering completed in July 2020 further strengthened our balance sheet.

 

The Company cautiously anticipates that the revenue for the full year 2020 will be within the range of €60 and €65 million.   CENTOGENE anticipates that the existing cash and cash equivalents, and the proceeds from the Follow-on Offering, will enable the Company to fund its operating expenses and capital expenditure requirements for more than 12 months.

 


 

Centogene N.V.

for the three and six months ended June 30, 2019 and 2020

 

Consolidated statements of comprehensive loss

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited,
€ in thousands)

 

Condensed consolidated statement of comprehensive loss:

 

 

 

 

 

 

 

 

 

Revenue

 

11,206

 

9,719

 

21,921

 

21,824

 

Cost of sales

 

6,114

 

6,815

 

12,858

 

13,833

 

Gross profit

 

5,092

 

2,904

 

9,063

 

7,991

 

Research and development expenses

 

2,407

 

3,119

 

4,108

 

5,810

 

General administrative expenses

 

5,693

 

7,767

 

11,603

 

15,665

 

Selling expenses

 

2,345

 

2,386

 

4,356

 

4,712

 

Other operating income

 

590

 

801

 

1,688

 

1,746

 

Other operating expenses

 

122

 

537

 

464

 

1,812

 

Real estate transfer tax expenses

 

1,200

 

 

1,200

 

 

Operating loss

 

(6,085

)

(10,104

)

(10,980

)

(18,262

)

Interest and similar income

 

4

 

13

 

12

 

13

 

Interest and similar expenses

 

221

 

269

 

431

 

718

 

Finance costs, net

 

(207

)

(256

)

(419

)

(705

)

Loss before taxes

 

(6,292

)

(10,360

)

(11,399

)

(18,967

)

Income tax (benefits)/expenses

 

(11

)

 

163

 

129

 

Loss for the period

 

(6,281

)

(10,360

)

(11,562

)

(19,096

)

Other comprehensive income/(loss)

 

8

 

(6

)

10

 

70

 

Total comprehensive loss for the period

 

(6,273

)

(10,366

)

(11,552

)

(19,026

)

Total comprehensive loss for the period attributable to the equity holders of the parent

 

(6,216

)

(10,364

)

(11,426

)

(18,963

)

 

 

 

 

 

 

 

 

 

 

Loss per share — Basic and diluted (in €)

 

(0.39

)

(0.52

)

(0.72

)

(0.95

)

 


 

Centogene N.V.

for the three and six months ended June 30, 2019 and 2020

 

Supplemental selected segment information

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited, € in thousands)

 

Revenue by segment:

 

 

 

 

 

 

 

 

 

Pharmaceutical

 

4,568

 

3,940

 

8,698

 

8,490

 

Diagnostics

 

6,638

 

5,779

 

13,223

 

13,334

 

Total Revenue

 

11,206

 

9,719

 

21,921

 

21,824

 

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited, € in thousands)

 

Segment Adjusted EBITDA:

 

 

 

 

 

 

 

 

 

Pharmaceutical

 

3,217

 

1,799

 

6,161

 

4,407

 

Diagnostics

 

530

 

(824

)

541

 

(737

)

Total segment Adjusted EBITDA

 

3,747

 

975

 

6,702

 

3,670

 

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

Reconciliation of segment Adjusted EBITDA to Group loss
for the period

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited, € in thousands)

 

Reported Segment Adjusted EBITDA

 

3,747

 

975

 

6,702

 

3,670

 

Corporate expenses

 

(6,185

)

(8,395

)

(10,005

)

(16,107

)

 

 

(2,438

)

(7,420

)

(3,303

)

(12,437

)

Share-based payment expenses

 

(2,195

)

(336

)

(4,828

)

(1,393

)

Depreciation and amortization

 

(1,452

)

(2,348

)

(2,849

)

(4,432

)

Operating loss

 

(6,085

)

(10,104

)

(10,980

)

(18,262

)

Finance costs, net

 

(207

)

(256

)

(419

)

(705

)

Income taxes benefits/(expenses)

 

11

 

 

(163

)

(129

)

Loss for the period

 

(6,281

)

(10,360

)

(11,562

)

(19,096

)

 


 

Centogene N.V.

As at December 31, 2019 and June 30, 2020

 

Consolidated statements of financial position

 

Assets

 

Dec 31, 2019

 

June 30, 2020

 

 

 

(unaudited, € in thousands)

 

Non-current assets

 

 

 

 

 

Intangible assets

 

14,145

 

16,452

 

Property, plant and equipment

 

8,376

 

10,784

 

Right-of-use assets

 

24,932

 

24,750

 

Other assets

 

1,948

 

2,003

 

 

 

49,401

 

53,989

 

Current assets

 

 

 

 

 

Inventories

 

1,809

 

8,061

 

Trade receivables and contract assets

 

16,593

 

14,983

 

Other assets

 

8,612

 

8,482

 

Cash and cash equivalents

 

41,095

 

17,400

 

 

 

68,109

 

48,926

 

 

 

117,510

 

102,915

 

 

Equity and liabilities

 

Dec 31, 2019

 

June 30, 2020

 

Equity

 

 

 

 

 

Issued capital

 

2,383

 

2,383

 

Capital reserve

 

98,099

 

99,492

 

Retained earnings and other reserves

 

(40,622

)

(60,340

)

Non-controlling interests

 

(938

)

(53

)

 

 

58,922

 

41,482

 

Non-current liabilities

 

 

 

 

 

Non-current loans

 

1,578

 

567

 

Lease liabilities

 

18,069

 

18,948

 

Deferred tax liabilities

 

 

121

 

Government grants

 

9,941

 

9,575

 

 

 

29,588

 

29,211

 

Current liabilities

 

 

 

 

 

Government grants

 

1,348

 

1,384

 

Current loans

 

3,688

 

4,367

 

Lease liabilities

 

3,635

 

3,411

 

Trade payables

 

8,554

 

8,828

 

Other liabilities

 

11,775

 

14,232

 

 

 

29,000

 

32,222

 

 

 

117,510

 

102,915

 

 


 

Centogene N.V.

for the six months ended June 30, 2019 and 2020

 

Consolidated statements of cashflow

 

 

 

For the Six Months Ended
June 30,

 

 

 

2019

 

2020

 

 

 

(unaudited, € in thousands)

 

 

 

 

 

 

 

Loss before taxes

 

(11,399

)

(18,967

)

Amortization and depreciation

 

2,849

 

4,432

 

Interest income

 

(12

)

(13

)

Interest expense

 

431

 

718

 

Expected credit loss allowances on trade receivables and contract assets

 

462

 

1,674

 

Share-based payment expenses

 

4,828

 

1,393

 

Real Estate transfer tax expenses

 

1,200

 

 

Other non-cash items

 

(147

)

(557

)

Changes in operating assets and liabilities:

 

 

 

 

 

Inventories

 

(360

)

(6,252

)

Trade receivables and contract assets

 

(2,556

)

(64

)

Other assets

 

(244

)

269

 

Trade payables

 

2,095

 

274

 

Other liabilities

 

946

 

2,457

 

Cash flow used in operating activities

 

(1,907

)

(14,636

)

 

 

 

 

 

 

Cash paid for investments in intangible assets

 

(3,116

)

(3,965

)

Cash paid for investments in property, plant and equipment

 

(840

)

(3,072

)

Grant received for investment in property, plant and equipment

 

341

 

390

 

Interest received

 

12

 

13

 

Cash flow used in investing activities

 

(3,603

)

(6,634

)

 

 

 

 

 

 

Cash paid for acquisition of non-wholly owned subsidiary

 

 

(75

)

Cash received from loans

 

1,828

 

928

 

Cash repayment of loans

 

(896

)

(1,260

)

Cash repayments of lease liabilities

 

(649

)

(1,619

)

Interest paid

 

(431

)

(399

)

Cash flow used in financing activities

 

(148

)

(2,425

)

 

 

 

 

 

 

Changes in cash and cash equivalents

 

(5,658

)

(23,695

)

Cash and cash equivalents at the beginning of the period

 

9,222

 

41,095

 

Cash and cash equivalents at the end of the period

 

3,564

 

17,400

 

 


 

Call Instructions

 

Centogene will host a conference call to discuss its financial results for the three and six months ended June 30, 2020 on Wednesday,  September 23, 2020 at 8 a.m. Eastern Time. The call can be accessed by dialing U.S. toll free +1 877 870 9135 or U.K. +44 (0) 844 481 9752 up to 10 minutes prior to the start of the call and providing the conference ID number 9368556. A presentation and webcast of the conference call can be accessed on the Investor Relations page of our website at http://investors.centogene.com

 

About CENTOGENE

 

CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies. Our goal is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our extensive rare disease knowledge, including epidemiological and clinical data, as well as innovative biomarkers. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository with over 3.6 billion weighted data points from approximately 570,000 patients representing over 120 different countries as of August 31, 2020.

 

The Company’s platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, and also a biobank of these patients’ blood samples. CENTOGENE believes this represents the only platform that comprehensively analyzes multi-level data to improve the understanding of rare hereditary diseases, which can aid in the identification of patients and improve our pharmaceutical partners’ ability to bring orphan drugs to the market. As of August 31, 2020, the Company collaborated with over 40 pharmaceutical partners covering over 45 different rare diseases.

 

Important Notice and Disclaimer

 

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of our strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project” or “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the Company. However, these forward-looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements.  Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, such as negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and govern-mental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

 

For further information, please refer to the Risk Factors section in our Annual Report for the year ended December 31, 2019 on Form 20-F filed with the SEC on April 23, 2020, Form 6-K containing our financial results for the three months ended March 31, 2020, filed with the SEC on June 15, 2020 and other current reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

 


 

Media Contact:

 

CENTOGENE
Sun Kim
Chief Strategy and Investor Relations Officer
investor.relations@centogene.com

 

FTI Consulting

Bridie Lawlor
+1.917.929.5684
bridie.lawlor@fticonsulting.com

 


Exhibit 99.2

 

Centogene N.V.

Unaudited interim condensed consolidated statements of comprehensive loss

for the three and six months ended June 30, 2019 and 2020

(in EUR k)

 

 

 

 

 

For the three months ended Jun 30

 

For the six months ended June 30

 

 

 

Note

 

2019

 

2020

 

2019

 

2020

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

4, 5

 

11,206

 

9,719

 

21,921

 

21,824

 

Cost of sales

 

 

 

6,114

 

6,815

 

12,858

 

13,833

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

 

5,092

 

2,904

 

9,063

 

7,991

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

 

2,407

 

3,119

 

4,108

 

5,810

 

General administrative expenses

 

 

 

5,693

 

7,767

 

11,603

 

15,665

 

Selling expenses

 

 

 

2,345

 

2,386

 

4,356

 

4,712

 

Other operating income

 

6.1

 

590

 

801

 

1,688

 

1,746

 

Other operating expenses

 

6.2

 

122

 

537

 

464

 

1,812

 

Real estate transfer tax expenses

 

7

 

1,200

 

 

1,200

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

 

(6,085

)

(10,104

)

(10,980

)

(18,262

)

 

 

 

 

 

 

 

 

 

 

 

 

Interest and similar income

 

 

 

4

 

13

 

12

 

13

 

Interest and similar expense

 

 

 

211

 

269

 

431

 

718

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial costs, net

 

 

 

(207

)

(256

)

(419

)

(705

)

 

 

 

 

 

 

 

 

 

 

 

 

Loss before taxes

 

 

 

(6,292

)

(10,360

)

(11,399

)

(18,967

)

Income tax (benefits)/expenses

 

 

 

(11

)

 

163

 

129

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

 

(6,281

)

(10,360

)

(11,562

)

(19,096

)

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income/(loss), all attributable to equity holders of the parent

 

 

 

8

 

(6

)

10

 

70

 

Total comprehensive loss

 

 

 

(6,273

)

(10,366

)

(11,552

)

(19,026

)

 

 

 

 

 

 

 

 

 

 

 

 

Attributable to:

 

 

 

 

 

 

 

 

 

 

 

Equity holders of the parent

 

 

 

(6,216

)

(10,364

)

(11,426

)

(18,963

)

Non-controlling interests

 

 

 

(57

)

(2

)

(126

)

(63

)

 

 

 

 

(6,273

)

(10,366

)

(11,552

)

(19,026

)

 

 

 

 

 

 

 

 

 

 

 

 

Loss per share - Basic and diluted (in EUR)

 

 

 

(0.39

)

(0.52

)

(0.72

)

(0.95

)

 

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements

 

1


 

Centogene N.V.

Unaudited interim condensed consolidated statements of financial position

as at December 31, 2019 and June 30, 2020

(in EUR k)

 

Assets

 

Note

 

Dec 31, 2019

 

Jun, 2020

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangible assets

 

 

 

14,145

 

16,452

 

Property, plant and equipment

 

 

 

8,376

 

10,784

 

Right-of-use assets

 

 

 

24,932

 

24,750

 

Other assets

 

8

 

1,948

 

2,003

 

 

 

 

 

 

 

 

 

 

 

 

 

49,401

 

53,989

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Inventories

 

 

 

1,809

 

8,061

 

Trade receivables and contract assets

 

8

 

16,593

 

14,983

 

Other assets

 

8

 

8,612

 

8,482

 

Cash and cash equivalents

 

9

 

41,095

 

17,400

 

 

 

 

 

 

 

 

 

 

 

 

 

68,109

 

48,926

 

 

 

 

 

 

 

 

 

 

 

 

 

117,510

 

102,915

 

 

Equity and liabilities

 

Note

 

Dec 31, 2019

 

Jun, 2020

 

 

 

 

 

 

 

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issued capital

 

10

 

2,383

 

2,383

 

Capital reserve

 

10

 

98,099

 

99,492

 

Retained earnings and other reserves

 

 

 

(40,622

)

(60,340

)

Non-controlling interests

 

 

 

(938

)

(53

)

 

 

 

 

 

 

 

 

 

 

 

 

58,922

 

41,482

 

 

 

 

 

 

 

 

 

Non-current liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-current loans

 

11.1

 

1,578

 

567

 

Lease liabilities

 

11.1

 

18,069

 

18,948

 

Deferred tax liabilities

 

 

 

 

121

 

Government grants

 

11.2

 

9,941

 

9,575

 

 

 

 

 

 

 

 

 

 

 

 

 

29,588

 

29,211

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Government grants

 

11.2

 

1,348

 

1,384

 

Current loans

 

11.1

 

3,688

 

4,367

 

Lease liabilities

 

11.1

 

3,635

 

3,411

 

Trade payables

 

11.2

 

8,554

 

8,828

 

Other liabilities

 

11.2

 

11,775

 

14,232

 

 

 

 

 

 

 

 

 

 

 

 

 

29,000

 

32,222

 

 

 

 

 

 

 

 

 

 

 

 

 

117,510

 

102,915

 

 

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements

 

2


 

Centogene N.V.

Unaudited interim condensed consolidated statements of cash flows

for the six months ended June 30, 2019 and 2020

(in EUR k)

 

 

 

Note

 

2019

 

2020

 

 

 

 

 

 

 

 

 

Operating activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before taxes

 

 

 

(11,399

)

(18,967

)

 

 

 

 

 

 

 

 

Adjustments to reconcile loss to cash flow from operating activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization and depreciation

 

5

 

2,849

 

4,432

 

Interest income

 

 

 

(12

)

(13

)

Interest expense

 

 

 

431

 

718

 

Expected credit loss allowances on trade receivables and contract assets

 

6.2, 8

 

462

 

1,674

 

Share-based payment expenses

 

12

 

4,828

 

1,393

 

Real Estate transfer tax expenses

 

7

 

1,200

 

 

Other non-cash items

 

 

 

(147

)

(557

)

 

 

 

 

 

 

 

 

Changes in operating assets and liabilities

 

 

 

 

 

 

 

Inventories

 

 

 

(360

)

(6,252

)

Trade receivables and contract assets

 

8

 

(2,556

)

(64

)

Other assets

 

8

 

(244

)

269

 

Trade payables

 

11.2

 

2,095

 

274

 

Other liabilities

 

11.2

 

946

 

2,457

 

 

 

 

 

 

 

 

 

Cash flow used in operating activities

 

 

 

(1,907

)

(14,636

)

 

 

 

 

 

 

 

 

Investing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid for investments in intangible assets

 

5

 

(3,116

)

(3,965

)

Cash paid for investments in property, plant and equipment

 

 

 

(840

)

(3,072

)

Grants received for investment in property, plant and equipment

 

11.2

 

341

 

390

 

Interest received

 

 

 

12

 

13

 

 

 

 

 

 

 

 

 

Cash flow used in investing activities

 

 

 

(3,603

)

(6,634

)

 

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

 

 

Cash paid for acquisition of non-wholly owned subsidiary

 

 

 

 

(75

)

Cash received from loans

 

11.1

 

1,828

 

928

 

Cash repayments of loans

 

11.1

 

(896

)

(1,260

)

Cash repayments of lease liabilities

 

11.1

 

(649

)

(1,619

)

Interest paid

 

 

 

(431

)

(399

)

 

 

 

 

 

 

 

 

Cash flow used in financing activities

 

 

 

(148

)

(2,425

)

 

 

 

 

 

 

 

 

Changes in cash and cash equivalents

 

 

 

(5,658

)

(23,695

)

Cash and cash equivalents at the beginning of the period

 

 

 

9,222

 

41,095

 

Cash and cash equivalents at the end of the period

 

 

 

3,564

 

17,400

 

 

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements

 

3


 

Centogene N.V.

Unaudited interim condensed consolidated statements of changes in equity

for the six months ended June 30, 2019 and 2020

 

 

 

 

 

Attributable to the owners of the parent

 

 

 

 

 

in EUR k

 

Note

 

Issued
capital

 

Capital
reserve

 

Currency
translation
reserve

 

Retained
earnings

 

Total

 

Non-
controlling
interests

 

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of January 1, 2019

 

 

 

1,903

 

45,342

 

(16

)

(19,948

)

27,281

 

(757

)

26,524

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

 

 

 

 

(11,436

)

(11,436

)

(126

)

(11,562

)

Other comprehensive loss

 

 

 

 

 

10

 

 

10

 

 

10

 

Total comprehensive loss

 

 

 

 

 

10

 

(11,436

)

(11,426

)

(126

)

(11,552

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based payments

 

12

 

 

488

 

 

 

488

 

 

488

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of June 30, 2019

 

 

 

1,903

 

45,830

 

(6

)

(31,384

)

16,343

 

(883

)

15,460

 

 

 

 

 

 

Attributable to the owners of the parent

 

 

 

 

 

in EUR k

 

Note

 

Issued
capital

 

Capital
reserve

 

Currency
translation
reserve

 

Retained
earnings

 

Total

 

Non-
controlling
interests

 

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of January 1, 2020

 

 

 

2,383

 

98,099

 

 

(40,622

)

59,860

 

(938

)

58,922

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

 

 

 

 

(19,033

)

(19,033

)

(63

)

(19,096

)

Other comprehensive loss

 

 

 

 

 

70

 

 

70

 

 

70

 

Total comprehensive loss

 

 

 

 

 

70

 

(19,033

)

(18,963

)

(63

)

(19,026

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based payments

 

12

 

 

1,393

 

 

 

1,393

 

 

1,393

 

Disposal of non-wholly owned subsidiary

 

6.2

 

 

 

 

 

 

268

 

268

 

Acquisition of non-wholly owned subsidiary

 

 

 

 

 

 

(755

)

(755

)

680

 

(75

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of June 30, 2020

 

 

 

2,383

 

99,492

 

70

 

(60,410

)

41,535

 

(53

)

41,482

 

 

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements

 

4


 

GRAPHIC

 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

1                      General company information

 

Centogene N.V. (“the Company”) and its subsidiaries focus on rare diseases and seek to transform real-world clinical and genetic data into actionable information for patients, physicians and pharmaceutical companies. The mission of the Company is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our knowledge of the global rare disease market, including epidemiological and clinical data and innovative biomarkers.

 

On November 7, 2019, the Company completed an initial public offering (“IPO”) and has since been listed on Nasdaq Global Market under stock code “CNTG”. We have historically conducted our business through Centogene AG (which is now known as Centogene GmbH), and therefore our historical financial statements present the results of operations and financial condition of Centogene AG and its controlled subsidiaries. In connection with our initial public offering, Centogene N.V. became the holding company of Centogene AG on November 12, 2019, and the historical consolidated financial statements of Centogene AG became the historical consolidated financial statements of Centogene N.V.  Centogene N.V. is a public company with limited liability incorporated in the Netherlands, with registered office located at Am Strande 7 in 18055 Rostock, Germany and Dutch trade register number 72822872.

 

On March 5, 2020, the Company resolved that Centogene AG shall be converted into a German limited liability company and renamed Centogene GmbH. Such conversion became effective upon the registration in the German commercial register on June 29, 2020. Unless otherwise stated, “Centogene GmbH” also refers to the historical operations of Centogene AG throughout the notes.

 

In July 2020, the Company completed a follow-on public offering of 3,500,000 common shares of the Company (the “July 2020 Offering”), consisting of 2,000,000 common shares offered by the Company and 1,500,000 common shares offered by selling shareholders at a price to the public of USD 14.00 per common share (i.e. EUR 12.71 per share). Aggregate offering proceeds, net of underwriting discounts and commissions, were EUR 24 million to the Company and EUR 18 million to the selling shareholders.

 

5


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

2                      Basis of preparation

 

The interim condensed consolidated financial statements for the three and six months ended June 30, 2019 and 2020 have been prepared in accordance with IAS 34 Interim Financial Reporting.

 

The interim condensed consolidated financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Group’s annual consolidated financial statements as of December 31, 2018 and 2019 and for the three years ended December 31, 2019.  Unless otherwise specified, “the Company” refers to Centogene N.V. and Centogene GmbH throughout the remainder of these notes, while “the Group” refers to Centogene N.V., Centogene GmbH and its subsidiaries.

 

The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group’s annual consolidated financial statements for the year ended December 31, 2019, except for the adoption of new standards effective as of January 1, 2020 (see note 2.1). The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.

 

Several other amendments and interpretations apply for the first time in 2020, but do not have an impact on the interim condensed consolidated financial statements of the Group.

 

These interim condensed consolidated financial statements are presented in euro, which is the Group’s functional currency. Unless otherwise specified, all financial information presented in euro is rounded to the nearest thousand (EUR k) in line with customary commercial practice.

 

2.1                     Effects of new accounting standards

 

The following amendments and interpretations apply for the first time in 2020 and had no impact on the condensed consolidated financial statements of the Group:

 

·                  Amendments to IAS 1 and IAS 8: Definition of Material

 

·                  Amendments to IFRS 3: Definition of a Business

 

·                  Amendments to IFRS 7, IFRS 9 and IAS 39: Interest Rate Benchmark Reform

 

·                  References to the Conceptual Framework for Financial Reporting issued on 29 March 2018

 

6


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

3                      Effect of COVID-19 Pandemic

 

The COVID-19 pandemic, which began in December 2019, has spread worldwide and continues to cause many governments to maintain measures to slow the spread of the outbreak through quarantines, travel restrictions, closures of borders and requiring maintenance of physical distance between individuals.

 

The Company has commenced testing for COVID-19 since the end of March 2020.   Starting from the Mecklenburg-Western Pomerania region of Germany focusing on employees and essential workers in Rostock, the testing for COVID-19 was further expanded to nursing homes as well as to high school students in Germany, and made available to the rest of the world since May 2020. Some of the tests are offered free of charge by the Company, while others are offered in collaboration with the state government, educational institutions and other companies, as well as via the online marketplace.

 

Revenues are based on a negotiated price per test or on the basis of agreements covering tests to be performed over defined periods.  Given the short turnaround time for the COVID-19 tests, revenues from COVID-tests which are on a price per test basis are considered as recognized at a point in time.  Revenues from COVID-19 tests which are on the basis of agreements covering tests to be performed over defined periods are considered as recognized over time. Revenues generated from the testing for COVID-19 for the three and six months ended June 30, 2020 amounted to EUR 2,082k and EUR 2,095k, respectively, and are included in the revenues of the diagnostics segment.  Out of the total revenues from the testing for COVID-19, EUR 2,072k and EUR 2,085k were generated in Europe for the three and six months ended June 30, 2020, of which over 95% in Germany, which is the country of the registered office of the Company.  Total direct costs incurred for the COVID-19 tests in the three and six months ended June 30, 2020 amounted to EUR 1,283k and EUR 1,360k, respectively, of which EUR 424k and EUR 483k, respectively, are related to the tests offered free of charge and are included accordingly in general administrative expenses and research and development expenses, as appropriate.

 

7


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

To support the expansion of test offerings, the Company acquired laboratory facilities and equipment for a total consideration of EUR 1,800k and leased laboratory space in Hamburg, Germany, in April 2020.  In July 2020, the Company further leased laboratory space in Frankfurt, Germany.   Total investments in COVID-19 testing as of June 30, 2020 amounted to approximately EUR 2.5 million, of which approximately EUR 1.9 million and EUR 0.6 million, respectively, are included in property plant and equipment and right-of-use assets.

 

4                      Revenues from contracts with customers

 

Three months ended June 30

 

 

 

Three months ended June 30, 2019

 

in EUR k

 

Pharmaceutical

 

Diagnostics

 

Total

 

Rendering of services

 

4,227

 

6,638

 

10,865

 

Sales of goods

 

341

 

 

341

 

Total Revenues from contracts with external customers

 

4,568

 

6,638

 

11,206

 

 

 

 

 

 

 

 

 

Recognized over time

 

3,996

 

6,638

 

10,634

 

Recognized at a point in time

 

572

 

 

572

 

Total Revenues from contracts with external customers

 

4,568

 

6,638

 

11,206

 

 

 

 

 

 

 

 

 

Geographical information

 

 

 

 

 

 

 

Europe

 

247

 

1,883

 

2,130

 

- Germany*

 

195

 

71

 

266

 

Middle East

 

29

 

3,189

 

3,218

 

- Saudi Arabia#

 

 

1,495

 

1,495

 

North America

 

4,292

 

644

 

4,936

 

- United States#

 

4,292

 

564

 

4,856

 

Latin America

 

 

681

 

681

 

Asia Pacific

 

 

241

 

241

 

Total Revenues from contracts with external customers

 

4,568

 

6,638

 

11,206

 

 


* country of the incorporation of Centogene GmbH

# countries contributing more than 10% of the Group’s  total consolidated revenues for the three months ended June 30, 2019

 

8


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

 

 

Three months ended June 30, 2020

 

in EUR k

 

Pharmaceutical

 

Diagnostics

 

Total

 

Rendering of services

 

3,606

 

5,737

 

9,343

 

Sales of goods

 

334

 

42

 

376

 

Total Revenues from contracts with external customers

 

3,940

 

5,779

 

9,719

 

 

 

 

 

 

 

 

 

Recognized over time

 

3,606

 

4,206

 

7,812

 

Recognized at a point in time

 

334

 

1,573

 

1,907

 

Total Revenues from contracts with external customers

 

3,940

 

5,779

 

9,719

 

 

 

 

 

 

 

 

 

Geographical information

 

 

 

 

 

 

 

Europe

 

23

 

3,204

 

3,226

 

- Germany*

 

19

 

2,096

 

2,115

 

- Netherlands**

 

 

 

 

Middle East

 

45

 

1,789

 

1,834

 

- Saudi Arabia#

 

 

1,106

 

1,106

 

North America

 

3,872

 

501

 

4,374

 

- United States#

 

3,872

 

493

 

4,365

 

Latin America

 

 

219

 

219

 

Asia Pacific

 

 

66

 

66

 

Total Revenues from contracts with external customers

 

3,940

 

5,779

 

9,719

 

 


* country of the incorporation of Centogene GmbH

** country of the incorporation of Centogene N.V.

# countries contributing more than 10% of the Group’s  total consolidated revenues for the three months ended June 30, 2020

 

Six months ended June 30

 

 

 

Six months ended June 30, 2019

 

in EUR k

 

Pharmaceutical

 

Diagnostics

 

Total

 

Rendering of services

 

8,033

 

13,223

 

21,256

 

Sales of goods

 

665

 

 

665

 

Total Revenues from contracts with external customers

 

8,698

 

13,223

 

21,921

 

 

 

 

 

 

 

 

 

Recognized over time

 

7,452

 

13,223

 

20,675

 

Recognized at a point in time

 

1,246

 

 

1,246

 

Total Revenues from contracts with external customers

 

8,698

 

13,223

 

21,921

 

 

 

 

 

 

 

 

 

Geographical information

 

 

 

 

 

 

 

Europe

 

280

 

3,411

 

3,691

 

- Germany*

 

195

 

133

 

328

 

Middle East

 

61

 

6,711

 

6,772

 

- Saudi Arabia#

 

 

3,182

 

3,182

 

North America

 

8,357

 

1,321

 

9,678

 

- United States#

 

8,357

 

972

 

9,329

 

Latin America

 

 

1,319

 

1,319

 

Asia Pacific

 

 

461

 

461

 

Total Revenues from contracts with external customers

 

8,698

 

13,223

 

21,921

 

 


* country of the incorporation of Centogene GmbH

# countries contributing more than 10% of the Group’s total consolidated revenues for the six months ended June 30, 2019

 

9


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

 

 

Six months ended June 30, 2020

 

in EUR k

 

Pharmaceutical

 

Diagnostics

 

Total

 

Rendering of services

 

7,880

 

13,292

 

21,172

 

Sales of goods

 

610

 

42

 

652

 

Total Revenues from contracts with external customers

 

8,490

 

13,334

 

21,824

 

 

 

 

 

 

 

 

 

Recognized over time

 

7,880

 

11,761

 

19,641

 

Recognized at a point in time

 

610

 

1,573

 

2,183

 

Total Revenues from contracts with external customers

 

8,490

 

13,334

 

21,824

 

 

 

 

 

 

 

 

 

Geographical information

 

 

 

 

 

 

 

Europe

 

67

 

4,820

 

4,887

 

- Germany*

 

38

 

2,169

 

2,207

 

- Netherlands**

 

 

3

 

3

 

Middle East

 

48

 

6,204

 

6,252

 

- Saudi Arabia#

 

 

4,139

 

4,139

 

North America

 

8,375

 

1,122

 

9,497

 

- United States#

 

8,375

 

964

 

9,339

 

Latin America

 

 

965

 

965

 

Asia Pacific

 

 

223

 

223

 

Total Revenues from contracts with external customers

 

8,490

 

13,334

 

21,824

 

 


* country of the incorporation of Centogene GmbH

** country of the incorporation of Centogene N.V.

# countries contributing more than 10% of the Group’s total consolidated revenues for the six months ended June 30, 2020

 

10


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

The Group collaborated with the majority of our pharmaceutical partners on a worldwide basis in 2019 and 2020. In addition, in cases where our pharmaceutical partners are developing a new rare disease treatment, it is generally anticipated that the final approved treatment will be made available globally.  As a result, we allocate the revenues of our pharmaceutical segment by geographical region by reference to the location where each pharmaceutical partner mainly operates, which is based on the region from which most of their revenues are generated. The allocation of revenues in our diagnostics segment is based on the location of each customer.

 

Pharmaceutial segment

 

During the three and six months ended June 30, 2020, revenues from one pharmaceutical partner represented 26.2% and 26.4% respectively, of the Group’s total revenues (the three and six months ended June 30, 2019: 26.7% and 27.1%, respectively).

 

During the three and six months ended June 30, 2019, we have entered into two collaborations with an existing pharmaceutical partner, of which upfront fees totaling EUR 80k and EUR 430k, respectively, representing the transaction price allocated to the one-off transfer of the Group’s intellectual property were received and recognized as revenues.  No such revenues were recognized in the three and six months ended June 30, 2020.

 

The Group recognized impairment losses on receivables and contract assets arising from contracts with customers, included under Other operating expenses in the consolidated statement of comprehensive loss, amounting to EUR 500k and EUR 1,674k, respectively, for the three and six months ended June 30, 2020 (the three and six months ended June 30, 2019: EUR 122k and EUR 462k, respectively).

 

11


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

5                      Segment information

 

Three months ended June 30

 

 

 

Three months ended June 30, 2019

 

in EUR k

 

Pharmaceutical

 

Diagnostics

 

Corporate

 

Total

 

Total Revenues from contracts with external customers

 

4,568

 

6,638

 

 

11,206

 

 

 

 

 

 

 

 

 

 

 

Adjusted EBITDA

 

3,217

 

530

 

(6,185

)

(2,438

)

 

 

 

 

 

 

 

 

 

 

Capital Expenditures

 

 

 

 

 

 

 

 

 

Additions to property, plant and equipment and right-of-use assets

 

172

 

227

 

 

399

 

Additions to intangible assets

 

1,018

 

 

985

 

2,003

 

 

 

 

 

 

 

 

 

 

 

Other segment information

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

257

 

561

 

635

 

1,453

 

Research and development expenses

 

 

 

2,407

 

2,407

 

 

 

 

Three months ended June 30, 2020

 

in EUR k

 

Pharmaceutical

 

Diagnostics

 

Corporate

 

Total

 

Total Revenues from contracts with external customers

 

3,940

 

5,779

 

 

9,719

 

 

 

 

 

 

 

 

 

 

 

Adjusted EBITDA

 

1,799

 

(824

)

(8,395

)

(7,420

)

 

 

 

 

 

 

 

 

 

 

Capital Expenditures

 

 

 

 

 

 

 

 

 

Additions to property, plant and equipment and right-of-use assets

 

301

 

2,073

 

1,249

 

3,623

 

Additions to intangible assets

 

1,852

 

 

922

 

2,774

 

 

 

 

 

 

 

 

 

 

 

Other segment information

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

389

 

617

 

1,342

 

2,348

 

Research and development expenses

 

 

 

3,119

 

3,119

 

 

12


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

Six months ended June 30

 

 

 

Six months ended June 30, 2019

 

in EUR k

 

Pharmaceutical

 

Diagnostics

 

Corporate

 

Total

 

Total Revenues from contracts with external customers

 

8,698

 

13,223

 

 

21,921

 

 

 

 

 

 

 

 

 

 

 

Adjusted EBITDA

 

6,161

 

541

 

(10,005

)

(3,303

)

 

 

 

 

 

 

 

 

 

 

Capital Expenditures

 

 

 

 

 

 

 

 

 

Additions to property, plant and equipment and right-of-use assets

 

179

 

247

 

414

 

840

 

Additions to intangible assets

 

1,786

 

 

1,330

 

3,116

 

 

 

 

 

 

 

 

 

 

 

Other segment information

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

513

 

1,085

 

1,252

 

2,849

 

Research and development expenses

 

 

 

4,108

 

4,108

 

 

 

 

Six months ended June 30, 2020

 

in EUR k

 

Pharmaceutical

 

Diagnostics

 

Corporate

 

Total

 

Total Revenues from contracts with external customers

 

8,490

 

13,334

 

 

21,824

 

 

 

 

 

 

 

 

 

 

 

Adjusted EBITDA

 

4,407

 

(737

)

(16,107

)

(12,437

)

 

 

 

 

 

 

 

 

 

 

Capital Expenditures

 

 

 

 

 

 

 

 

 

Additions to property, plant and equipment and right-of-use assets

 

301

 

2,890

 

1,836

 

5,027

 

Additions to intangible assets

 

2,854

 

 

1,111

 

3,965

 

 

 

 

 

 

 

 

 

 

 

Other segment information

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

1,071

 

1,161

 

2,200

 

4,432

 

Research and development expenses

 

 

 

5,810

 

5,810

 

 

Adjustments

 

Corporate expenses, depreciation and amortization, interest and similar income and expenses, as well as share-based payment expenses are not allocated to individual segments as the underlying instruments are managed on a group basis. Current taxes and deferred taxes are allocated to Corporate as they are also managed on a group basis.

 

13


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

Increases in corporate expenses for the three and six months ended June 30, 2020 are mainly due to our continued international growth and business expansion.  The increase is also due to the costs of operating as a public company, such as additional legal, accounting, corporate governance and investor relations expenses, and higher directors’ and officers’ insurance premiums.

 

Corporate expenses for the three and six months ended June 30, 2020 included expenses related to the July 2020 Offering as described in note 1 of EUR 173k and EUR 173k, respectively, while corporate expenses for the three and six months ended June 30, 2019  included expenses incurred in relation to the IPO as described in note 1 of EUR 109k and EUR 318k, respectively (included in General Administrative Expenses).  Corporate expenses for the three and six months ended June 30, 2019 also included real estate transfer tax of EUR 1,200k related to an intercompany sale of land and building.  No such expenses were incurred in the six months ended June 30, 2020 (see note 7).

 

Capital expenditure consists of additions of property, plant and equipment, right-of-use assets and intangible assets.  All of such assets are located in Germany, which is the country of the registered office of the Company, except for property, plant and equipment of EUR 368k (December 31, 2019: EUR 286k) and right-of-use assets of EUR 876k (December 31, 2019: EUR 1,042k), which is located in the United States.

 

Reconciliation of segment Adjusted EBITDA to Group loss for the period

 

For the three months ended June 30

 

2019

 

2020

 

Reported segment Adjusted EBITDA

 

3,747

 

975

 

Corporate expenses

 

(6,185

)

(8,395

)

 

 

(2,438

)

(7,420

)

Share-based payment expenses

 

(2,195

)

(336

)

Depreciation and amortization

 

(1,452

)

(2,348

)

Operating loss

 

(6,085

)

(10,104

)

Financial costs, net

 

(207

)

(256

)

Income taxes benefit

 

11

 

 

Loss for the three months ended June 30

 

(6,281

)

(10,360

)

 

14


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

For the six months ended June 30

 

2019

 

2020

 

Reported segment Adjusted EBITDA

 

6,702

 

3,670

 

Corporate expenses

 

(10,005

)

(16,107

)

 

 

(3,303

)

(12,437

)

Share-based payment expenses

 

(4,828

)

(1,393

)

Depreciation and amortization

 

(2,849

)

(4,432

)

Operating loss

 

(10,980

)

(18,262

)

Financial costs, net

 

(419

)

(705

)

Income taxes expenses

 

(163

)

(129

)

Loss for the the six months ended June 30

 

(11,562

)

(19,096

)

 

6                      Other income and expenses

 

6.1                     Other operating income

 

 

 

For the three months
ended June 30

 

For the six months
ended June 30

 

in EUR k

 

2019

 

2020

 

2019

 

2020

 

Government grants

 

503

 

703

 

1,470

 

1,405

 

Income from the reversal of provisions

 

 

 

89

 

 

Others

 

87

 

98

 

129

 

341

 

Total other operating income

 

590

 

801

 

1,688

 

1,746

 

 

Government grants contain performance-based grants to subsidize research, development and innovation in the state of Mecklenburg-Western Pomerania from funds granted by the European Regional Development Fund. Furthermore, government grants contain the release of deferred income from investment related grants.

 

6.2                     Other operating expenses

 

 

 

For the three months
ended June 30

 

For the six months
ended June 30

 

in EUR k

 

2019

 

2020

 

2019

 

2020

 

Currency losses

 

 

37

 

2

 

37

 

Expected credit loss allowances on trade receivables

 

122

 

500

 

462

 

1,674

 

Others

 

 

 

 

101

 

Total other operating expenses

 

122

 

537

 

464

 

1,812

 

 

15


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

Considering the impact of the COVID-19 pandemic on the global economy and the unforeseeable potential magnitude of the ultimate disruptions to different businesses, the Group has taken such new developments into consideration when assessing its credit risk, in particular regarding the MENA region for the diagnostic segment as it represents the majority of that segment’s revenue.  Such assessment resulted in the recognition of additional credit losses of EUR 500k and EUR 1,674k, respectively, for the three and six months ended June 30, 2020 (for the three and six months ended June 30, 2019: EUR 122k and EUR 462k, respectively).  See also note 8.

 

During the six months ended June 30, 2020, the Group disposed of its entire 51% interest in LPC GmbH (“LPC”) to the minority shareholders for a consideration of EUR 213k, of which EUR 200k is to be paid over a period of four years (and included in other assets, see note 8).   The related non-controlling interest of EUR 268k (accumulated share of loss) was debited to profit or loss, and the sale resulted in a loss of EUR 101k.

 

7                      Sale and Leaseback transaction

 

In June 2019, in preparation for a sale and leaseback transaction, the Company sold its land and building (the Rostock headquarters building) with a carrying value of EUR 22,778k to another subsidiary of the Group. Such intercompany transaction resulted in a real estate transfer tax expense of EUR 1,200k and was recognized in the three and six months period ended June 30, 2019.

 

8                      Trade receivables and contract assets and other assets

 

in EUR k

 

Dec 31, 2019

 

Jun 30, 2020

 

Non-current

 

 

 

 

 

Other assets — Rental deposits

 

1,948

 

1,853

 

Other assets — Others

 

 

150

 

 

 

1,948

 

2,003

 

Current

 

 

 

 

 

Trade receivables, net

 

12,709

 

12,473

 

Contract assets, net

 

3,884

 

2,510

 

Receivables due from shareholders

 

2,766

 

2,766

 

Other assets

 

5,846

 

5,716

 

 

 

25,205

 

23,465

 

 

 

 

 

 

 

Total non-current and current trade receivables and contract assets and other assets

 

27,153

 

25,468

 

 

16


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and

2020

 

Trade receivables and contract assets

 

Trade receivables are non-interest bearing and are generally due in 30 to 90 days.  In general, portfolio-based expected credit loss allowances are recognized on trade receivables and contract assets.

 

Considering the potential impact of the COVID-19 pandemic on the global economy, the Group has  re-assessed the credit loss rates in relation to the outstanding trade receivables and contract assets as follows:

 

in EUR k

 

Dec 31, 2019

 

Jun 30, 2020

 

Not past due

 

11,102

 

10,340

 

Past due 1-30 days

 

1,113

 

1,159

 

Past due 31-90 days

 

1,708

 

1,508

 

Past due more than 90 days

 

5,005

 

5,985

 

Total Gross amount of trade receivables and contract assets

 

18,928

 

18,992

 

 

 

 

 

 

 

Expected credit loss rate

 

 

 

 

 

Not past due

 

0.3

%

0.6

%

Past due 1-30 days

 

1.0

%

5.7

%

Past due 31-90 days

 

1.2

%

7.6

%

Past due more than 90 days

 

45.4

%

62.9

%

Expected credit loss rate on total gross trade receivables and contract assets

 

12.3

%

21.3

%

 

 

 

 

 

 

 Expected credit loss

 

2,335

 

4,009

 

 

Receivables due from shareholders

 

In 2016, the Group established a virtual share option program (“2016 VSOP”) under Centogene GmbH that entitled the management board to grant virtual share options to individuals, in regard to services they provide and their continuous commitment to the Group.  Upon completion of the IPO in November 2019, all options granted under the 2016 VSOP were vested immediately in full, and the holders of vested options were entitled to receive a direct cash payment from the Company according to the calculation as stipulated in the 2016 VSOP, which is determined based on the IPO price of the shares of Centogene N.V. and the exercise prices of the vested options.

 

The payables by the Group to the holders of vested options were recorded as a liability with a carrying amount of EUR 2,766k (December 31, 2019: EUR 2,766k) (see note 11.2).  As the payments to the option holders would be reimbursed by certain original shareholders to the Company, corresponding receivables against shareholders were recorded. 

 

17


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

Such receivables were considered as additional capital from shareholders and recorded against equity (capital reserve). Upon completion of the July 2020 Offering, the relevant payables to the holders of vested options were settled by the proceeds received from such original shareholders from the sale of their shares.

 

Other assets

 

The non-current portion of other assets mainly include cash deposit of EUR 1,500k (used to secure a bank guarantee of EUR 3,000k) relating to the leases of Rostock headquarters building, cash deposits of EUR 128k (used to secure a bank guarantee of EUR 257k) relating to the leases of Berlin office and EUR 191k for the leases of certain plant and machineries.   It also includes the consideration receivable for the sale of LPC of EUR 213k, among which EUR 150k is due after 1 year (see note 6.2).

 

The current portion of other assets also include VAT receivables of EUR 1,124k (December 31, 2019: EUR 1,311k), prepaid expenses of EUR 2,150k (December 31, 2019: EUR 3,481k) as well as receivables from grants of EUR 1,068k (December 31, 2019: EUR 409k).

 

Other assets also include costs relating to the July 2020 Offering of EUR 552k (December 31, 2019: EUR nil) which will be offset against capital reserve upon completion of the transaction in July 2020.

 

9                      Cash and short-term deposits

 

As of June 30, 2020, the Group has pledged its short-term deposits with carrying amount of EUR 1,500k (December 31, 2019: EUR 1,500k) and EUR 2,500k (December 31, 2019: EUR 2,500k) respectively, to fulfil collateral requirements in respect of existing secured bank loan and overdraft facility up to EUR 2,500k.

 

In addition, the Group has pledged its short-term deposits of EUR 500k (December 31, 2019: EUR nil) related to another overdraft facility up to EUR 500k.

 

The restriction applying to the collateral may be terminated at any time subject to the full amount of the relevant bank loans and the overdrafts being repaid.

 

18


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

10               Equity

 

As discussed in note 1, Centogene N.V. became the parent holding company of the Group on November 12, 2019 as part of the IPO process.  All share, per-share and related information presented in the financial statements and corresponding disclosure notes have been retrospectively adjusted, where applicable, to reflect the impact of the share split resulting from the reorganization.

 

Capital reserve

 

As of June 30, 2020, capital reserve included a share premium of EUR 90,297k, being amounts contributed by shareholders at the issuance of shares in excess of the par value of the shares issued, net of any transaction costs incurred for the share issuance.

 

In addition, it also included amounts recorded in respect of share-based payments. For additional information on the share-based payments, see note 12.

 

11               Financial liabilities

 

11.1              Interest-bearing liabilities

 

in EUR k

 

Dec 31, 2019

 

Jun 30, 2020

 

Non-current liabilities

 

 

 

 

 

Non-current portion of secured bank loans

 

968

 

567

 

Municipal loans

 

610

 

 

Total non-current loans

 

1,578

 

567

 

Lease liabilities

 

18,069

 

18,948

 

Total non-current liabilities

 

19,647

 

19,515

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Current portion of secured bank loans

 

802

 

802

 

Other bank loans

 

 

438

 

Bank overdrafts

 

2,636

 

3,127

 

Municipal loans

 

250

 

 

Total current loans

 

3,688

 

4,367

 

Current portion of lease liabilities

 

3,635

 

3,411

 

Total current liabilities

 

7,323

 

7,778

 

 

 

 

 

 

 

Total non-current and current liabilities

 

26,970

 

27,293

 

 

19


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

As of June 30, 2020, short-term cash deposits of EUR 1,500k (December 31, 2019: EUR 1,500k) were used to secure the secured bank loan outstanding (see note 9).

 

Other bank loans outstanding as of June 30, 2020 represented bank loans granted under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) which was enacted in March 2020 in the United States, which was a stimulus bill intended to, among other things, bolster the U.S. economy, and provide assistance to qualifying businesses and individuals. The CARES Act included an infusion of funds into the healthcare system.  The loans were to be used for payment of payroll to employees in the United States, as well as rent and other utility payment obligations.  Subject to certain reporting and review requirements, the Company may apply for forgiveness of the amount during the 8-week period beginning on the date of first disbursement of the loans.  The Company is in the process of preparing the relevant application and anticipates the result of the forgiveness will be available in 2020.  The amount which is forgiven will be considered as government grant income, while any remaining amount not forgiven will be repaid by the Company.  Accordingly, the entire amount was classified as current.

 

The following table is based on the original terms and conditions:

 

Conditions and statement of liabilities

 

The outstanding interest-bearing liabilities as of June 30, 2020 and December 31, 2019 have the following conditions:

 

 

 

 

 

 

 

 

 

Dec 31, 2019

 

Jun 30, 2020

 

in EUR k

 

Currency

 

Nominal interest rate

 

Maturity

 

Nominal amount

 

Carrying amount

 

Nominal amount

 

Carrying amount

 

Secured bank loan

 

EUR

 

3.95%

 

2018-25

 

1,770

 

1,770

 

1,369

 

1,369

 

Other bank loan

 

USD

 

1%

 

2020-22

 

 

 

438

 

438

 

Municipal loan

 

EUR

 

8.25%; plus 1.5% profit-related; 0.75% on losses

 

2018-23

 

500

 

500

 

 

 

Municipal loan

 

EUR

 

8%; plus 1.5% profit-related; 0.75% on losses

 

2021

 

360

 

360

 

 

 

Bank overdrafts

 

EUR

 

4.46%

 

2022

 

476

 

476

 

478

 

478

 

Bank overdrafts

 

EUR

 

3.75%

 

Rollover

 

2,160

 

2,160

 

2,346

 

2,346

 

Bank overdrafts

 

EUR

 

3.59%

 

Rollover

 

 

 

303

 

303

 

Lease liabilities

 

EUR

 

2.1%-3.5%*,5.4%-8.9%

 

2017-31

 

21,704

 

21,704

 

22,359

 

22,359

 

Total interest-bearing financial liabilities

 

 

 

 

 

 

 

26,970

 

26,970

 

27,293

 

27,293

 

 


* represents the incremental borrowing rate of the Group at the commencement of the leases

 

20


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

The bank overdrafts of EUR 2,346k as of June 30, 2020 (December 31, 2019: EUR 2,160k) were secured by short-term deposits with a carrying amount of EUR 2,500k (December 31, 2019: EUR 2,500k) (see note 9). The bank overdrafts of EUR 478k (December 31, 2019: EUR 476k) were secured by guarantees provided by certain of the Company’s shareholders as of December 31, 2019, and were released providing security over a short-term deposit with a carrying amount of EUR 500k subsequent to the year end (see note 9).

 

The municipal loan due to MBMV (Mittelständische Bürgschaftsbank Mecklenburg-Vorpommern) of EUR 860k outstanding as of December 31, 2019 was secured by guarantees provided by the Group’s shareholders, and were released upon full repayment in February 2020.

 

11.2              Trade payables and other liabilities

 

in EUR k

 

Dec 31, 2019

 

Jun 30, 2020

 

Trade payables

 

8,554

 

8,828

 

Government grants (deferred income)

 

11,289

 

10,959

 

Liability for Virtual Stock Option Program

 

2,769

 

2,766

 

Contract liabilities

 

3,748

 

3,800

 

Others

 

5,258

 

7,666

 

Trade payables and other liabilities

 

31,618

 

34,019

 

Non-current

 

9,941

 

9,575

 

Current

 

21,677

 

24,444

 

 

Government grants mainly include investment-related government grants. These were received for the purchase of certain items of property, plant and equipment for the research and development facilities in Mecklenburg-Western Pomerania, including the Rostock facility. The grants were issued in the form of investment subsidies as part of the joint federal and state program, “Verbesserung der regionalen Wirtschaftsstruktur” (improvement of the regional economic structure) in connection with funds from the European Regional Development Fund. Additional grants received during the six months ended June 30, 2020 are related to the purchase of certain items of property, plant and equipment amounted to EUR 390k (the six months ended June 30, 2019: EUR 341k).

 

In addition, other liabilities include personnel-related liabilities for vacation and bonuses totaling EUR 2,907k (December 31, 2019: EUR 2,264k) as well as liabilities for wage and church tax of EUR 527k (December 31, 2019: EUR 376k). Other liabilities as of June 30, 2020 include costs related to the July 2020 Offering of EUR 725k, while other liabilities as of December 31, 2019 included costs relating to the IPO of EUR 565k.

 

21


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

12               Share-based payments

 

At June 30, 2020 the Group had the following share-based payment arrangements.

 

(i)                                     Equity share option - Replacement (ESOP 2017)

 

In 2017, the Group established a second virtual share option program (“2017 VSOP”) that entitled the management board to grant virtual share options to individuals, in regard to services they provide and their continuous commitment to the Group.

 

In connection with the IPO (see note 1), a transfer agreement was entered into between the holders of the 2017 VSOP, Centogene GmbH and the Company in November 2019, under which the 2017 VSOP was terminated, and the option holders were granted new share options of Centogene N.V. (“ESOP 2017”).

 

The number of options granted to each holder under ESOP 2017 was based on the number of options granted to them under 2017 VSOP and the IPO price of Centogene N.V. Accordingly, 805,308 new share options were granted pursuant to Centogene N.V’s long-term incentive plan (the “Long-term Incentive Plan”), with each option representing one common share of Centogene N.V., and an exercise price equal to the nominal value of the share of Centogene N.V., which is EUR 0.12.

 

The options were considered vested upon the completion of the IPO, but were not exercisable in the first 180 days subsequent to the listing (lock-up period).

 

The contractual life for the share options as at June 30, 2020 is 9.5 years (December 31, 2019: 10 years).

 

The share options issued under ESOP 2017 are equity-settled and the fair value of the options were fully recognized in equity under capital reserve on the date of grant.

 

22


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

(ii)                                  Equity share option 2019 (ESOP 2019)

 

In 2019, an agreement was entered into between the Company and an individual of the Supervisory Board. According to this agreement, a total of 396,522 options, each option representing one common share, were granted pursuant to the Long-term Incentive Plan to the individual Supervisory Board member with exercise price equaling to the IPO price, which is EUR 12.58 per option, on the date of the IPO of the Company. The vesting period shall be three years commencing on the day of grant, where one-third of the granted options shall be vested at the end of each year of grant, and the first year ending on March 31, 2020.

 

The contractual life for the share options as at December 31, 2019 is ten years and the weighted average fair value of options outstanding was EUR 9.08. The share options issued under “ESOP 2019” will be equity-settled and the fair value of the options were recognized in equity under capital reserve, based on the fair value on the date of grant, and will be charged to profit or loss over the vesting period by using the graded vested approach.  For the three and six months ended June 30, 2020, the Group recognized EUR 336k and EUR 1,393k repectively, of share-based payment expense in the statement of comprehensive income.

 

For the six months ended June 30, 2019, the Group recognized EUR 4,828k of share-based payment expense in the statement of comprehensive income in relation to the cash-settled virtual share option programs of Centogene GmbH, which were cancelled upon completion of IPO.

 

13               Commitments

 

Future payments for non-cancellable leases

 

The Group has various lease contracts in relation to the expansion of the Rostock headquarters and leasing of the Frankfurt laboratory that have not yet commenced as at June 30, 2020. The future lease payments and utilities for these non-cancellable lease contracts are EUR 32k within one year, EUR 1,218k within five years and EUR 5,324k thereafter.

 

The Group has various non-cancellable lease contracts of office equipment and storage spaces which had a lease term of less than 12 months or were related to leases of low-value assets, and therefore the short-term lease recognition exemption was applied to these contracts. The future lease payments for these non-cancellable lease contracts are EUR 75k within one year (December 31, 2019: EUR 72k) and EUR 23k within five years (December 31, 2019: EUR 36k).

 

23


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

Future payment obligations

 

As of June 30, 2020, the Group concluded agreements with suppliers, for goods and services to be provided subsequent to June 30, 2020 with a total payment obligation of approximately EUR 6,172k (December 31, 2019: EUR 802k).

 

14               Contingent Liabilities

 

In May 2016, the Company was informed in writing by the Universitair Medisch Centrum Utrecht (‘‘UMCU’’) that a claim had been initiated against UMCU regarding a prenatal diagnostic test that the Company conducted at their request which failed to identify a specific mutation present in a patient. On November 8, 2018, the UMCU and Neon Underwriting Limited formally filed a legal claim in the local court in Rostock, Germany against the Company alleging that the Company’s negligence in performing the test resulted in the misdiagnosis of the patient. UMCU is seeking recovery for compensatory damages as a result of the alleged misdiagnosis. By court order of November 8, 2018 the Regional Court of Rostock set the amount in dispute at EUR 880k.

 

On November 12, 2018, the Company submitted a notice to the Regional Court of Rostock of the intention to defend against the claim. On January 3, 2019, the Company filed a motion to dismiss in which the Company denied the merits of the claim. UMCU and Neon Underwriting Limited responded to this motion on March 15, 2019 with a statement of reply, and the parties made several court filings setting out their arguments since. By order dated June 3, 2019, the Regional Court of Rostock provided a first set of questions to be answered by an expert witness. Following a request by the Court, the Director of the Institute of Genetics at the University of Bonn recommended a professor for human genetics from the University of Aachen be appointed as an expert witness in this case. The Company agreed to such recommendation.

 

During the 3 months ended June 30, 2020, the dispute amount was increased to EUR 1.3 million.  The claim was assigned to a new judge, due to an illness of the preceding judge, while the decision to appoint the recommended expert witness has not yet been finalized. 

 

24


 

Notes to the unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three months and six months ended June 30, 2019 and 2020

 

The Company intends to continue to rigorously defend its position and considers that it is not probable the legal claim towards the Company will be successful and as a result has not recognized a provision for this claim as of June 30, 2020. In addition, in case a settlement would be required, the Company believes that the corresponding liability will be fully covered by the respective existing insurance policies.

 

15               Subsequent Event

 

July 2020 Offering

 

On July 14, 2020, the Company completed a follow-on offering of 3,500,000 common shares of the Company, consisting of 2,000,000 common shares offered by the Company and 1,500,000 common shares offered by selling shareholders at a price to the public of USD 14.00 per common share (i.e. EUR 12.71 per share). Aggregate offering proceeds, net of underwriting discounts and commissions, were EUR 24 million to the Company and EUR 18 million to the selling shareholders.

 

Upon the completion of the offering, proceeds to certain selling holders, who are also the shareholders backing 2016 VSOP under Centogene GmbH, were received by the Company, which were then used to settle the payables to the vested option holders in July 2020.

 

These unaudited interim condensed consolidated financial statements were approved by management on September 23, 2020.

 

25


Exhibit 99.3

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion of our financial condition and results of operations should be read in conjunction with Centogene N.V.’s unaudited interim condensed consolidated financial statements as of December 31, 2019 and June 30, 2020 and for the three and six months ended June 30, 2019 and 2020 included as Exhibit 99.2 to this report on Form 6-K. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements and the notes thereto included in our annual report for the year ended December 31, 2019 on Form 20-F, filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the U.S. Securities and Exchange Act of 1934, as amended, on April 23, 2020 (the “Annual Report”).

 

Unless otherwise indicated or the context otherwise requires, all references to “Centogene N.V.” or the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to Centogene N.V. and its subsidiaries.

 

The following discussion is based on our financial information prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”), which may differ in material respects from generally accepted accounting principles in the United States and other jurisdictions.

 

This discussion and analysis is dated as of September 23, 2020.

 

Overview

 

We are a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians and pharmaceutical companies. Our goal is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our knowledge of the global rare disease market, including epidemiological and clinical data and innovative biomarkers. We have developed a global proprietary rare disease platform based on our real-world data repository with over 3.6 billion weighted data points from approximately 570,000 patients representing 120 different countries as of August 31, 2020, or an average of over 660 data points per patient. Our platform includes multiomic data (such as epidemiologic, phenotypic, proteomic, metabolomic and genetic data) that reflects a global population, and also a biobank of these patients’ blood samples. We believe this represents the only platform that comprehensively analyzes multi-level data to improve the understanding of rare hereditary diseases, which can aid in the identification of patients and improve our pharmaceutical partners’ ability to bring orphan drugs to the market.

 

We have identified two reportable segments:

 

·                  Pharmaceutical.  Our pharmaceutical solutions provide a variety of services to our pharmaceutical partners, including target discovery, early patient recruitment and identification, epidemiological insights, biomarker discovery and patient monitoring. Our information platforms, access to rare disease patients and their biomaterials, and ability to develop proprietary technologies and biomarkers enable us to provide services to our pharmaceutical partners in all phases of the drug development process as well as post-commercialization. Revenues from our pharmaceutical segment are generated primarily from collaboration agreements with our pharmaceutical partners. As of June 30, 2020, we collaborated with over 40 pharmaceutical partners for over 45 different rare diseases. In addition, out of the over 60 single biomarker development programs as of June 30, 2020, 33 were used in connection with our pharmaceutical collaborations.   Since early 2020, we also started to pursue a metabolomics approach for establishing a biomarker discovery pipeline for rare hereditary disease. Our new approach includes a tandem mass spectrometry (ion mobility quadrupole time-of-flight mass spectrometry) methodology and artificial intelligence and, combined with the large volume of datasets in our global rare disease platform, has proven successful in the identification of new biomarkers. The new biomarker candidates identified are then further validated and optimized in epidemiological clinical trials.

 


 

·                  Diagnostics.  Our diagnostics segment provides targeted genetic sequencing and diagnostics services to our clients worldwide, who are typically physicians, laboratories or hospitals, either directly or through distributors. As of June 30, 2020, we believe we offer the broadest diagnostic testing portfolio for rare diseases, covering over 7,500 genes using over 10,000 different tests. In turn, the data collected from our diagnostics services and biomaterials allow us to continue to grow our repository and our CentoMD database.

 

We have also commenced testing for COVID-19 since the end of March 2020.  Our COVID-19 test is a molecular diagnostic test performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in oropharyngeal samples from presymptomatic probands according to the recommended testing by public health authority guidelines. It has also been validated in CENTOGENE’s CAP / CLIA / ISO certified analytical laboratory and has received Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) for use by authorized laboratories. The tests are processed in our specialized laboratories in Hamburg and Frankfurt, Germany, which were newly established in April 2020 and July 2020, respectively.  To date,  some of the test requests for our COVID-19 tests are offered free of charge as additional measures to protect our employees as well as initiatives to support the community to overcome the challenges of the pandemic, while the billable tests are offered through collaborations with the state government and other companies.

 

In the three months ended June 30, 2020, we received over 84,400 test requests, of which 65,850 account for COVID-19 tests.  Excluding the COVID-19 test requests, we received 18,550 test requests in the three months ended June 30, 2020, representing a 43.1% decrease as compared to approximately 32,600 test requests received during the three months ended June 30, 2019.  In the six months ended June 30, 2020, we received approximately 121,100 test requests, of which over 70,050 account for our COVID-19 tests.  Excluding the COVID-19 test requests, we received 51,050 test requests in the six months ended June 30, 2020, representing a 18.1% decrease as compared to approximately 62,300 test requests received in the six months ended June 30, 2019.

 

Our revenue for the three months ended June 30, 2020 was €9,719 thousand, a decrease of €1,487 thousand, or 13.3%, from €11,206 thousand for the three months ended June 30, 2019. Our pharmaceutical and diagnostics segments contributed 40.5% and 59.5%, respectively, of our total revenues for the three months ended June 30, 2020, as compared to 40.8% and 59.2%, respectively, of our total revenues for the three months ended June 30, 2019. Test requests received by our pharmaceutical segment in the three months ended June 30, 2020 were 9,900, representing a decrease of 40.7% as compared to 16,700 test requests received in the three months ended June 30, 2019.  Test requests received by our diagnostics segment in the three months ended June 30, 2020, excluding COVID-19 test requests, were 7,000, representing a decrease of 45.7% as compared to 12,900 test requests received in the three months ended June 30, 2019.

 

Our revenue for the six months ended June 30, 2020 was €21,824 thousand, a decrease of €97 thousand, or 0.4%, from €21,921 thousand for the six months ended June 30, 2019. Our pharmaceutical and diagnostics segments contributed 38.9% and 61.1%, respectively, of our total revenues for the six months ended June 30, 2020, as compared to 39.7% and 60.3%, respectively, of our total revenues for the six months ended June 30, 2019. Test requests received by our pharmaceutical segment in the six months ended June 30, 2020 were 27,500, representing a decrease of 11.0% as compared to 30,900 test requests received in the six months ended June 30, 2019.  Test requests received by our diagnostics segment in the six months ended June 30, 2020, excluding COVID-19 test requests, were 20,000, representing a decrease of 22.8% as compared to 25,900 test requests received in the six months ended June 30, 2019.

 

Since the inception of our business, our research and development has been substantially devoted to our biomarkers, knowledge-based platform and interpretation-based solutions. For the three months ended June 30, 2020, we incurred research and development expenses of €3,119 thousand, an increase of €712 thousand, or 29.6%, from €2,407 thousand for the three months ended June 30, 2019.  During the three months ended June 30, 2020 and 2019, we received 1,650 and 3,000 test requests for our internal research and development projects, respectively.  For the six months ended June 30, 2020, we incurred research and development expenses of €5,810 thousand, an increase of €1,702 thousand, or 41.4%, from €4,108 thousand for the six months ended June 30, 2019.  During the six months ended June 30, 2020 and 2019, we received 3,550 and 5,500 test requests for our internal research and development projects, respectively.

 


 

For the three months ended June 30, 2020, our loss before taxes was €10,360 thousand, an increase of €4,068 thousand, or 64.7%, from €6,292 thousand for the three months ended June 30, 2019.  For the six months ended June 30, 2020, our loss before taxes was €18,967 thousand, an increase of €7,568 thousand, or 66.4%, from €11,399 thousand for the six months ended June 30, 2019.

 

Recent Developments

 

Effect of the COVID-19 Pandemic

 

The COVID-19 pandemic, which began in December 2019, has spread worldwide and continues to cause many governments to maintain measures to slow the spread of the outbreak through quarantines, travel restrictions, closures of borders and mandatory maintenance of physical distance between individuals.  We have been continuously monitoring the situation and have taken a series of measures to protect our employees and safeguard our operations.   By the end of May 2020, the Company was able to have most of the employees return to work at the office by implementing regular testing.  In addition, we have purchased additional inventories to secure the materials required for our COVID-19 tests as well as for those used in our routine business.

 

As part of the Company’s initiative to assist local, national and international authorities in their efforts to facilitate the earliest possible diagnosis of COVID-19 and thereby contribute to allowing society to return to a ‘‘new’’ normal, the Company commenced testing for COVID-19 in March 2020.  We offer a comprehensive and high quality COVID-19 testing solution to the community.   This includes our COVID-19 tests, which received EUAs from the FDA in July 2020; our CentoSwab, a fully validated sample collection kit which can either be used by healthcare professionals or self-administered by individuals; and our Corona-App and test portal, a secure digital platform following stringent data privacy measures in compliance with the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA), allowing seamless registration and result notification.

 

Starting from the Mecklenburg-Western Pomerania region of Germany, where we focused on employees and essential workers in Rostock, our COVID-19 testing solution was further expanded to nursing homes as well as to high school students in Germany, and made available to the rest of the world since May 2020.  Some of our tests are offered free of charge by the Company, while others are offered in collaboration with the state government and other companies.  In particular, we entered into the following collaborations during the three months ended June 30, 2020:

 

·                  Collaboration with the OESIS Network Inc., a network of more than 600 schools across the United States, to conduct COVID-19 screening in schools in June 2020.

 

·                  Partnership with Lufthansa and Fraport, the operator of Frankfurt airport, to open the first COVID-19 walk-in test center at Frankfurt airport, offering COVID-19 testing to passengers flying to and from Frankfurt airport, as well as the general public who wish to perform COVID-19 tests, starting from the end June 2020.

 

Subsequent to June 2020, additional test centers were opened at Munich and Nuremberg Central Stations offering COVID-19 tests to travelers returning to Germany from “high risk regions” as defined by the Robert Koch Institute (RKI), the public health agency which compiles the COVID-19 statistics in Germany.  In August 2020, we opened an additional walk-in testing facility at Hamburg Airport offering COVID-19 testing to passengers departing from Hamburg and returning to Hamburg from “non-high risk” countries, as well as to the general public.   In addition, we are offering our testing kits, CentoKit-19, through the online marketplace Amazon in Germany.  The CentoKit-19 consists of a CE-labelled CentoSwab (a two-component dry plastic swab for oropharyngeal swab sampling), a collection tube with barcode sticker, and labelled and prepaid return boxes.

 

We received 65,850 and 70,050 test requests, respectively, for our COVID-19 tests in the three and six months ended June 30, 2020.  Out of the total test requests received for the six months ended June 30, 2020, approximately 22,210 test requests were provided to our employees, the community and for research and development purposes and were free of charge.  Revenues generated from the testing for COVID-19 and sales of CentoSwab for the three and six months ended June 30, 2020 amounted to €2,082 thousand and €2,095 thousand, respectively, and are included in the revenues of the diagnostics segment.  Total direct costs incurred for the COVID-19 tests in the three and six months ended June 30, 2020 amounted to €1,283 thousand and €1,360 thousand, respectively, of which €424 thousand and €483 thousand, respectively, were related to the free of charge tests and were, accordingly, included in general administrative expenses and research and development expenses, as appropriate.

 


 

To support the expansion of our COVID-19 test offerings, the Company, in April 2020, acquired laboratory facilities and equipment for a total consideration of €1.8 million and leased laboratory space in Hamburg, Germany.   Subsequently, in July 2020, the Company leased further laboratory space in Frankfurt, Germany.   Total investments in COVID-19 testing as of June 30, 2020 amounted to approximately €2.5 million, of which approximately €1.9 million and €0.6 million, respectively, are included in property, plant and equipment and right-of-use assets.  In addition, we have secured the production and supply of a sample collection kit for COVID-19 test, CentoSwab.

 

Due to the measures implemented to control the further spread of the outbreak, including “social distancing”, as well as the allocation of healthcare resources to treating those infected with the virus, we have seen a significant decrease in our sample volume related to our routine diagnostics business and pharmaceutical collaborations with fee per sample structure.  In addition, the pandemic also slowed the progress of the clinical studies of our pharmaceutical partners with whom we collaborate, which adversely affected our pharmaceutical business.  In addition, travel restrictions and the cancellation of conferences and seminars also delayed the conclusion of new collaborations with our pharmaceutical partners.

 

We saw a recovery in the number of test requests in July and August 2020, with the volume of test requests related to our diagnostics segment (ex- COVID-19 testing) and pharmaceutical segment in the period exceeding the volume of test requests received in the three months ended June 30, 2019.  We also successfully concluded five additional collaborations with our existing pharmaceutical partners subsequent to June 30, 2020. In addition, we received over 199,000 COVID-19  test requests in July and August 2020, of which approximately 163,850 were from Frankfurt and Hamburg airports, and approximately 22,420 tests were offered free of charge.

 

The graph below shows the number of  COVID-19 test requests received from the commencement of the testing in March 2020 to August 31, 2020.

 

GRAPHIC

 


*Test requests for COVID-19 for March to May 2020 are aggregated and shown in one column, representing the test requests before walk-in testing centers were established.

 

The price we charged for the COVID-19 tests ranged from €50 per test to €140 per test, depending on different factors such as turnaround time.  Therefore, we anticipate that the negative temporary impact on our core diagnostics and pharmaceutical revenues will be offset by the revenues from our COVID-19 tests.

 

Although we are taking a number of measures aimed at minimizing disruptions to our business and operations, and while the provision of testing for the COVID-19 virus is anticipated to generate additional revenues for us, the full extent to which the global COVID-19 pandemic may impact our business will depend on future developments, which are highly uncertain and cannot be predicted, such as the duration of the pandemic, the probability of the occurrence of a second outbreak and the ultimate impact on the financial markets and the global economy, and could result in an unforeseen negative impact on our business and our future results of operations.

 


 

Research and Development

 

Despite the disruption from the COVID-19 pandemic, we continued to expand our medical and genetic knowledge of rare genetic diseases, with the vision of shortening the diagnostics odyssey of rare disease patients and accelerating the development of new orphan drugs.  In particular, we entered into the following collaborations subsequent to the three months ended June 30, 2020:

 

·                  Collaboration with Molecular Health GmbH (“Molecular Health”) to jointly initiate the Real-life data and Innovative Bioinformatic Algorithms (“RIBA”) project.  Starting with epilepsy, RIBA aims to foster a unique novel precision medicine environment to accelerate, de-risk and improve the development of new orphan drugs by combining large real-life data sets in rare disease in our global proprietary rare disease platform, with the innovative artificial intelligence, computational algorithms and expertise of Molecular Health.

 

·                  Collaboration with Evotec SE (“Evotec”) in the research, discovery and development of medical solutions for rare diseases related to the protein target glucocerebrosidase (“GBA”), a well-known gene linked to Gaucher disease.  This collaboration combines our global proprietary rare disease platform and biomarker expertise, with the induced pluripotent stem cell (“iPSC”) platform, drug discovery and development capabilities of Evotec.

 

As of August 31, 2020, our global proprietary rare disease platform included real-world data repository with approximately 570,000 patients representing 120 different countries, an increase of 26.7% as compared to the number of patients in our platform as of August 31, 2019.   In August 2020, we released an update of CentoMD 5.8, our rare disease mutation database that includes validated, curated and anonymized patient data from our rare disease platform.  Our CentoMD 5.8 includes curated data from over 430,000 patients with over 12.7 million unique variants and over 3,900 associated phenotypes.

 

We also released an update of CentoLSD, powered by CentoMD, which we believe is the world’s largest knowledge-driven lysosomal storage disease (“LSD”) database.  CentoLSD allows researchers, pharmaceutical partners, and clinicians to access a comprehensive database of GBA and GLA genetic variants classified through a standardized curation workflow, and is accessible through our website free of charge, for the purpose of enhancing a global understanding and the potential treatment opportunities for rare disease patients.

 

Follow-on Equity Offering

 

In July 2020, we completed a follow-on public offering of 3,500,000 common shares of the Company (the “Follow-on Equity Offering”), consisting of 2,000,000 common shares offered by the Company and 1,500,000 common shares offered by selling shareholders at a price to the public of $14.00 per common share (i.e., €12.71 per share).  Aggregate offering proceeds, net of underwriting discounts and commissions, to the Company and the selling shareholders were €24 million and €18 million, respectively. With the additional funding from the Follow-on Equity Offering, we believe that our cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for more than 12 months.

 

Financial Operations Overview

 

Our revenue is principally derived from the provision of pharmaceutical solutions and diagnostic tests enabled by our knowledge and interpretation-based platform.

 

We expect our revenue to increase over time as we continue to expand our commercial efforts internationally with a focus on further growth in our pharmaceutical segment. As a result, we expect revenue from the pharmaceutical segment to increase as a proportion of total revenue over time. We expect revenue from our diagnostics segment to grow in absolute terms but decrease as a percentage of total revenue as we focus on growth in our pharmaceutical segment.

 

Changes in revenue mix between our pharmaceutical and diagnostics segments can impact our results period over period. We typically incur lower costs for the provision of solutions in our pharmaceutical segment and therefore generate higher returns from our pharmaceutical segment contracts than from our diagnostics segment contracts. As a result, we anticipate our gross profit as a percentage of total revenues to improve in the future.

 

For a discussion of our other key financial statement line items, please see “Item 5—Operating and Financial Review and Prospects—Operating Results—Financial Operations Overview” in our Annual Report.

 


 

Results of Operations

 

Three and Six Months Ended June 30, 2020 Compared to Three and Six Months Ended June 30, 2019

 

 

 

For the Three Months Ended
June 30,

 

For the Six Months Ended
June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited,
€ in thousands)

 

Condensed consolidated statement of comprehensive loss:

 

 

 

 

 

 

 

 

 

Revenue

 

11,206

 

9,719

 

21,921

 

21,824

 

Cost of sales

 

6,114

 

6,815

 

12,858

 

13,833

 

Gross profit

 

5,092

 

2,904

 

9,063

 

7,991

 

Research and development expenses

 

2,407

 

3,119

 

4,108

 

5,810

 

General administrative expenses

 

5,693

 

7,767

 

11,603

 

15,665

 

Selling expenses

 

2,345

 

2,386

 

4,356

 

4,712

 

Other operating income

 

590

 

801

 

1,688

 

1,746

 

Other operating expenses

 

122

 

537

 

464

 

1,812

 

Real estate transfer tax expenses

 

1,200

 

 

1,200

 

 

Operating loss

 

(6,085

)

(10,104

)

(10,980

)

(18,262

)

Interest and similar income

 

4

 

13

 

12

 

13

 

Interest and similar expenses

 

221

 

269

 

431

 

718

 

Finance costs, net

 

(207

)

(256

)

(419

)

(705

)

Loss before taxes

 

(6,292

)

(10,360

)

(11,399

)

(18,967

)

Income tax (benefits)/expenses

 

(11

)

 

163

 

129

 

Loss for the period

 

(6,281

)

(10,360

)

(11,562

)

(19,096

)

Other comprehensive income/(loss)

 

8

 

(6

)

10

 

70

 

Total comprehensive loss for the period

 

(6,273

)

(10,366

)

(11,552

)

(19,026

)

Total comprehensive loss for the period attributable to the equity holders of the parent

 

(6,216

)

(10,364

)

(11,426

)

(18,963

)

 

 

 

 

 

 

 

 

 

 

Loss per share – Basic and diluted (in €)

 

(0.39

)

(0.52

)

(0.72

)

(0.95

)

 

Revenue

 

Our total revenues for the three and six months ended June 30, 2020 were €9,719 thousand and €21,824 thousand, respectively, representing decreases of €1,487 thousand and €97 thousand, respectively, or 13.3% and 0.4%, respectively, as compared to the three and six months ended June 30, 2019.  Revenues from our COVID-19 tests and sales of Cento Swab, which amounted to €2,082 thousand and €2,095 thousand, respectively, were included in our total revenues for the three and six months ended June 30, 2020.

 

The graphic below shows the number of test requests for the diagnostics segment (excluding COVID-19 tests) and pharmaceutical segment, as well as the number of test requests received for our internal research projects during the three and six months ended June 30, 2019 and 2020.

 

 


*The testing expenses relating to requests received for our internal research projects were included in [Corporate] as they did not generate any revenue and cannot be allocated to either of our two business segments.

 


 

The breakdown of our revenue by segment was as follows:

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited,
€ in thousands)

 

Revenue by segment:

 

 

 

 

 

 

 

 

 

Pharmaceutical

 

4,568

 

3,940

 

8,698

 

8,490

 

Diagnostics

 

6,638

 

5,779

 

13,223

 

13,334

 

Total Revenue

 

11,206

 

9,719

 

21,921

 

21,824

 

 

Pharmaceutical segment

 

Revenues from our pharmaceutical segment were €3,940 thousand for the three months ended June 30, 2020, a decrease of €628 thousand, or 13.7%, from €4,568 thousand for the three months ended June 30, 2019. Our partnership agreements are structured on a fee per sample basis, milestone basis, fixed fee basis, royalty basis or a combination thereof.  The 13.7% decrease was primarily due to the impact of the COVID-19 pandemic, which slowed the clinical studies of our pharmaceutical partners.

 

Revenues from our pharmaceutical segment were €8,490 thousand for the six months ended June 30, 2020, a decrease of €208 thousand, or 2.4%, from €8,698 thousand for the six months ended June 30, 2019.

 

The total number of active/completed collaborations in the six months ended June 30, 2020 amounted to 63, as compared to 60 in the six months ended June 30, 2019.  As of June 30, 2020, we collaborated with 41 pharmaceutical partners, as compared to 35 pharmaceutical partners as of June 30, 2019.

 

The graphs below show our revenues for the three and six months ended June 30, 2020 and 2019, resulting from our collaborations with our pharmaceutical partners, split between drug development stages, as well as between different fee structures:

 

 


 

 

Revenues from our collaborations which are structured on a fixed fee basis represented 63.0% and 60.2%, respectively, of our total revenues for the three and six months ended June 30, 2020, as compared to 59.1% and 57.6%, respectively, for the three and six months ended June 30, 2019.  Given the fee structure, these revenues provide us with stable revenues and cashflow from the pharmaceutical segment.  As new and existing clinical trials were slowed down or put on hold, the COVID-19 pandemic had a more significant impact on those of our collaborations that are structured on a fee per sample basis.  Revenues from fee per sample collaborations were €0.4 million and €1.1 million, respectively, for the three and six months ended June 30, 2020, and decreased by 39.8% and 15.7%, respectively, as compared to the same periods in 2019.  Revenues from the fee per sample collaborations represented 9.7% and 12.5%, respectively, of our total revenues for the pharmaceutical segment for the three and six months ended June 30, 2020, and decreased by 4.2 percentage points and 1.9 percentage points, respectively, compared to the same periods in 2019.

 

During the three and six months ended June 30, 2019, we entered into two collaborations with an existing pharmaceutical partner, of which upfront fees totaling €80 thousand and €430 thousand, respectively, representing the transaction price allocated to the one-off transfer of the Group’s intellectual property were received and recognized as revenues.  No such revenues were recognized in the three and six months ended June 30, 2020.

 

During the three and six months ended June 30, 2020, revenues from one pharmaceutical partner represented 26.2% and 26.4%, respectively, of our total revenue, as compared to 26.7% and 27.1%, respectively, for the three and six months ended June 30, 2019.

 

Diagnostics segment

 

Revenues from our diagnostics segment were €5,779 thousand for the three months ended June 30, 2020, a decrease of €859 thousand, or 12.9%, from €6,638 thousand for the three months ended June 30, 2019.   Revenues from our diagnostics segment were €13,334 thousand for the six months ended June 30, 2020, an increase of €111 thousand, or 0.8%, from €13,223 thousand for the six months ended June 30, 2019.  Out of total revenues from our diagnostics segment for the three and six months ended June 30, 2020, 36.0% and 15.7%, respectively, were generated from our COVID-19 tests and sales of CentoSwab.

 

Excluding revenues from COVID-19 tests and sales of CentoSwab, revenues from our diagnostics segment for the three and six months ended June 30, 2020, decreased by 44.3% and 15.0%, respectively, as compared to those for the three and six months ended June 30, 2019.  The decreases were mainly due to decreases in test requests for all our primary rare diease testing products (i.e., standard genetic testing including single gene, CNV and mutation quantification products, panel sequencing, whole exome sequencing (“WES”) and whole genome sequencing (“WGS”), as well as non-invasive pre-natal testing (“NIPT”)  and biochemistry) as a result of the COVID-19 pandemic.  The decreases were also attributable to decreases in test requests for our NIPT, a non-core diagnostics product, which we intend to continue lowering the volume of, to focus more on the testing products that provide a larger quantity of data, such as WES and WGS, to continue growing our rare disease platform repository.

 


 

The graph below shows the test requests received in the diagnostics segment, split between primary rare diease testing products, for the three and six months ended June 30, 2020 and 2019:

 

 

For the three and six months ended June 30, 2020 and 2019, our total diagnostics segment revenues from our primary rare disease testing  products were as follows:

 

 

The revenues for the diagnostics segment are recognized over time by reference to the percentage of completion of the service on the reporting date, assessed on the basis of the work rendered.  The 44.3% decrease in revenues from our primary rare disease tests for the three months ended June 30, 2020, was primarily driven by the decrease in test requests across all testing products by 45.7% as compared to the three months ended June 30, 2019.  In particular, the decreases in test requests and revenues from our NIPT (non-core and relatively low price product) were 55.0% and 38.0%, respectively, for the three months ended June 30, 2020 as compared to the same period ended June 30, 2019 reflecting our strategy of moving towards testing products that provide a larger quantity of data.  The total number of WES and WGS test requests received in the diagnostics segment for the three months ended June 30, 2020, was approximately 2,040, representing 29.1% of total test requests for the period, and representing an increase of 5.9 percentage points as compared to the proportion of WES and WGS received over the total test requests received for the three months ended June 30, 2019.

 

The 15.0% decrease in revenues from our primary testing products for the six months ended June 30, 2020, was in line with the decrease in test requests by 22.8% as compared to the six months ended June 30, 2019, of which test requests and revenues from our NIPT decreased by 55.5% and 38.9%, respectively, for the six months ended June 30, 2020 as compared to the same period ended June 30, 2019.  On the other hand, the total number of WES and WGS test requests received in the diagnostics segment for the six months ended June 30, 2020 increased by 15.5% to 6,540 test requests, from approximately 5,660 test requests received for the six months ended June 30, 2019. Total number of WES and WGS test requests received in the diagnostics segment for the six months ended June 30, 2020 represented 32.8% of total primary rare disease test requests for the period, a 10.8 percentage points increase as compared to the proportion of WES and WGS received over the total test requests for the six months ended June 30, 2019.

 


 

The breakdown of our revenue from both of our segments, in the aggregate, by geographical region was as follows:

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited,
€ in thousands)

 

Revenue by geographical region:

 

 

 

 

 

 

 

 

 

Europe

 

2,130

 

3,226

 

3,691

 

4,887

 

of which: Germany

 

266

 

2,115

 

328

 

2,207

 

of which: Netherlands

 

 

 

 

3

 

Middle East

 

3,218

 

1,834

 

6,772

 

6,252

 

of which: Saudi Arabia

 

1,495

 

1,106

 

3,182

 

4,139

 

North America

 

4,936

 

4,374

 

9,678

 

9,497

 

of which: United States

 

4,856

 

4,365

 

9,329

 

9,339

 

Latin America

 

681

 

219

 

1,319

 

965

 

Asia Pacific

 

241

 

66

 

461

 

223

 

Total Revenue

 

11,206

 

9,719

 

21,921

 

21,824

 

 

In cases where our pharmaceutical partners are developing a new rare disease treatment, we generally anticipate that the final approved treatment will be made available globally. As a result, we allocate the revenues of our pharmaceutical segment by geographical region by reference to the location where each pharmaceutical partner mainly operates, which is based on the region from which most of their revenues are generated. The allocation of revenues in our diagnostics segment is based on the location of each customer.

 

Our North America region contributed €4,374 thousand to revenues for the three months ended June 30, 2020, a decrease of €562 thousand, or 11.4%, from €4,936 thousand for the three months ended June, 2019, primarily driven by the decrease in revenues from our pharmaceutical segment, of which over 90% are allocated to the North America region.  Revenues from the North America region for the six months ended June 30, 2020, decreased to €9,497 thousand, representing a decrease of €181 thousand, or 1.9%, from €9,678 thousand, which is mainly due to a decrease in revenues from the diagnostics segment by €199 thousand, or 15.1%, as compared to the six months ended June 30, 2020.  Revenues from the North America region represented 45.0% and 43.5%, respectively, of our total revenues for the three and six months ended June 30, 2020, as compared to 44.0% and 44.1%, respectively, for the three and six months ended June 30, 2019.

 

Our Middle East region contributed €1,834 thousand to revenues for the three months ended June 30, 2020, a decrease of €1,384 thousand, or 43.0%, from €3,218 thousand for the three months ended June 30, 2019. This was primarily attributable to the decrease in test requests received in our diagnostics segment by 55.8% in the three months ended June 30, 2020, as compared to the three months ended June 30, 2020.  The negative impact of the diagnostics segment in the Middle East region was partially offset by the increase in revenues in the first quarter of 2020. As a result, revenues from the Middle East region for the six months ended June 30, 2020 only decreased by €520 thousand, or 7.7%, to €6,252 thousand from €6,772 thousand for the six months ended June 30, 2020.  In addition, revenues from the Middle East region were also impacted by the cancellation of our fixed fee contract for sales of NIPT in September 2019.  Revenues from that fixed fee contract were €463 thousand and €1,039 thousand, respectively, in the three and six months ended June 30, 2019.  Revenues from the Middle East region represented 18.9% and 28.6%, respectively, of our total revenues for the three and six months ended June 30, 2020, as compared to 28.7% and 30.9%, respectively, for the three and six months ended June 30, 2019.

 

Our Europe region contributed €3,226 thousand and €4,887 thousand, respectively, to revenues for the three and six months ended June 30, 2020, representing increases of 51.5% and 32.4%, respectively, as compared to the three and six months ended June 30, 2019.  The increases were mainly driven by revenues from our COVID-19 testing during the period, as over 95% of such revenues were generated in Germany.  Revenues from the Europe region represented 33.2% and 22.4% respectively, of our total revenues for the three and six months ended June 30, 2020, as compared to 19.0% and 16.8%, respectively, for the three and six months ended June 30, 2019.

 


 

Cost of Sales

 

Cost of sales increased by €701 thousand, or 11.5%, to €6,815 thousand for the three months ended June 30, 2020, from €6,114 thousand for the three months ended June 30, 2019, and increased by €975 thousand, or 7.6%, to €13,833 thousand for the six months ended June 30, 2020, from €12,858 thousand for the six months ended June 30, 2019.  Cost of sales for the three and six months ended June 30, 2020 represented 70.1% and 63.4%, respectively, of total revenue, representing increases of 15.5 percentage points and 4.7 percentage points, respectively, as compared to 54.6% and 58.7%, respectively, for the three and six months ended June 30, 2019.

 

Cost of sales incurred by our pharmaceutical segment for the three and six months ended June 30, 2020 represented 49.8% and 45.4%, respectively, of the revenues from the segment, representing increases of 21.8 percentage points and 21.6 percentage points, respectively, as compared to 28.0% and 23.8%, respectively, for the three and six months ended June 30, 2019 for our pharmaceutical segment.  The increases were mainly due to a higher portion of revenues from clinical study related collaborations, where higher staff costs and consumable costs are incurred as compared to patient screening collaborations in the past where the consumable costs were comparatively low due to different technologies being used in the testing.

 

Cost of sales incurred by our diagnostics segment for the three months ended June 30, 2020 represented 84.0% of the revenues from the segment, representing an increase of 11.1 percentage points as compared to 72.9% for the three months ended June 30, 2019.  The increase was mainly due to the fixed costs incurred for the segment, such as depreciation of laboratory equipment, as well as personnel costs for employees for laboratory operations, and remained similar to the fixed costs incurred the previous quarter, notwithstanding the decrease in revenues for the period.

 

Cost of sales incurred by our diagnostics segment for the six months ended June 30, 2020 represented 74.8% of the revenues from the segment, representing a decrease of 6.8 percentage points as compared to 81.6% for the six months ended June 30, 2019 for our diagnostics segment.  The decrease was mainly due to a change in the product mix, with fewer NIPT tests (which have comparatively higher costs per test) performed in the six months ended June 2020, which more than offset an increase in cost of sales in the three months ended June 30, 2020.

 

Gross Profit

 

As a result of the above factors, our gross profit decreased by €2,188 thousand, or 43.0%, to €2,904 thousand for the three months ended June 30, 2020, from €5,092 thousand for the three months ended June 30, 2019, while our gross profit for the six months ended June 30, 2020,decreased by €1,072 thousand, or 11.8%, to €7,991 thousand from €9,063 thousand for the six months ended June 30, 2019.

 

Research and Development Expenses

 

The table below gives a breakdown of our research and development expenses for the three and six months ended June 30, 2020 and 2019.

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited,
€ in thousands)

 

Wages and salaries and social security expenses

 

929

 

1,257

 

1,809

 

2,177

 

Laboratory supplies and consumable costs

 

392

 

708

 

409

 

926

 

IT development costs

 

715

 

443

 

1,272

 

1,450

 

Depreciation and amortization expenses

 

323

 

631

 

525

 

1,018

 

Others

 

48

 

80

 

93

 

239

 

Total research and development expenses

 

2,407

 

3,119

 

4,108

 

5,810

 

 

Research and development expenses increased by €712 thousand, or 29.6%, to €3,119 thousand for the three months ended June 30, 2020, from €2,407 thousand for the three months ended June 30, 2019, while our research and development expense increased by €1,702 thousand, or 41.1%, to €5,810 thousand for the six months ended June 30, 2020, from €4,108 thousand for the six months ended June 30, 2019.   This mainly represents personnel costs, consumable costs and IT-related expenses incurred in the research phase that do not qualify for capitalization, or costs incurred for the updates or improvement of our biomarkers, databases and technology platform for which development is completed.

 


 

General Administrative Expenses

 

The table below gives a breakdown of our general administrative expenses for the three and six months ended June 30, 2020 and 2019.

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited,
€ in thousands)

 

Wages and salaries, social security and termination expenses

 

1,099

 

1,963

 

2,681

 

4,303

 

Share-based payment expenses

 

1,891

 

336

 

3,969

 

1,393

 

Legal and consulting expenses

 

346

 

1,634

 

811

 

2,653

 

Travelling, corporate communication and event expenses

 

908

 

359

 

1,224

 

861

 

IT operational costs

 

328

 

398

 

518

 

848

 

Insurance premiums

 

137

 

1,179

 

226

 

1,985

 

Depreciation and amortization expenses

 

310

 

711

 

696

 

1,300

 

Others

 

674

 

1,187

 

1,478

 

2,322

 

Total general administrative expenses

 

5,693

 

7,767

 

11,603

 

15,665

 

 

General administrative expenses increased by €2,074 thousand, or 36.4%, to €7,767 thousand for the three months ended June 30, 2020, from €5,693 thousand for the three months ended June 30, 2019, while general administrative expenses increased by €4,062 thousand, or 35.0%, to €15,665 thousand for the six months ended June 30, 2020, from €11,603 thousand for the six months ended June 30, 2019.

 

The increases were principally due to an increase in personnel costs and operating expenses as a result of the expansion of the business. The increase was also due to costs of operating as a public company, such as additional legal, accounting, corporate governance and investor relations expenses, and higher directors’ and officers’ insurance premiums.  General administrative expenses for the three and six months ended June 30, 2020 also included €267 thousand incurred in relation to COVID-19 tests offered free of charge to our employees and the community, and legal and consulting expenses of €173 thousand incurred in relation to our Follow-on Equity Offering completed in July 2020.

 

Share-based compensation expenses for the three and six months ended June 30, 2019 were calculated based on the estimated fair values of the share-based awards as of June 30, 2019, as well as the estimated number of awards expected to vest, while the share-based compensation expenses for the three and six months ended June 30, 2020 were based on the estimated fair values of the share-based awards at the grant date.

 

Selling Expenses

 

Selling expenses for the three and six months ended June 30, 2020 were €2,386 thousand and €4,712 thousand respectively, representing a minor increase of €41 thousand, or 1.7% as compared to €2,345 thousand for the three months ended June 30, 2019, and an increase of €356 thousand, or 8.2%, as compared to €4,356 thousand for the six months ended June 30, 2019.  The increases for the three and six months ended June 30, 2020  were mainly due to the expansion of our business development team for the pharmaceutical segment, offset by a reduction in expenses incurred for conferences and exhibitions due to travel restrictions and other social-distancing measures.

 

Other Operating Income / (Expenses)

 

Other operating income increased by €211 thousand, or 35.8%, to €801 thousand for the three months ended June 30, 2020, from €590 thousand for the three months ended June 30, 2019, and increased by €58 thousand, or 3.4%, to €1,746 thousand for the six months ended June 30, 2020, from €1,688 thousand for the six months ended June 30, 2019, principally due to higher grant income received during the periods.

 

Other operating expenses increased by €415 thousand and €1,348 thousand, respectively, to €537 thousand and €1,812 thousand, respectively, for the three and six months ended June 30, 2020, from €122 thousand and €464 thousand, respectively, for the three and six months ended June 30, 2019.   We considered the impact of the COVID-19 pandemic on the global economy and the unforeseeable impact and disruption to different businesses when assessing credit risk, in particular regarding the MENA region for the diagnostics segment as it represents the majority of that segment’s revenue.  As a result, the credit loss allowances on trade receivables and contract assets increased by €378 thousand and €1,212 thousand, respectively, to €500 thousand and €1,674 thousand for the three and six months ended June 30, 2020, as compared to increases of €122 thousand and €462 thousand, respectively, for the three and six months ended June 30, 2019.

 


 

Interest and Similar Income / (Expenses)

 

Interest and similar income decreased by €9 thousand and €1 thousand, respectively, to €13 thousand and €13 thousand, respectively, for the three and six months ended June 30, 2020, from €4 thousand and €12 thousand, respectively, for the three and six months ended June 30, 2019.

 

Interest and similar expenses increased by €58 thousand and €287 thousand, respectively, to €269 thousand and €718 thousand, respectively, for the three and six months ended June 30, 2020, from €211 thousand and €431 thousand, respectively, for the three and six months ended June 30, 2019, principally due to interest expenses in conjunction with the lease liabilities accounted for upon the adoption of IFRS 16 effective since January 1, 2019.

 

Real estate transfer tax

 

In June 2019, we sold our land and building, which had a carrying value of €22,778 thousand, to a subsidiary in preparation for a potential sale and leaseback transaction. Such intercompany transaction resulted in a real estate transfer tax expense of  €1,200 thousand and was recognized in the three and six months periods ended June 30, 2019.

 

Loss Before Taxes

 

As a result of the factors described above, our losses before taxes for the three and six months ended June 30, 2020 were €10,360 thousand and €18,967 thousand, respectively, representing increases of €4,068 thousand and €7,568 thousand, respectively, from losses before taxes of €6,292 thousand and €11,399 thousand, respectively, for the three and months ended June 30, 2019.

 

Segment Adjusted EBITDA

 

We evaluate segment performance based on segment results and measure it with reference to Adjusted EBITDA, which we define as operating loss presented in the consolidated statements of comprehensive loss, adjusted for corporate expenses, depreciation and amortization as well as share-based payment expenses. Our Segment Adjusted EBITDA was as follows:

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

2019

 

2020

 

 

 

(unaudited,
€ in thousands)

 

Segment Adjusted EBITDA:

 

 

 

 

 

 

 

 

 

Pharmaceutical

 

3,217

 

1,799

 

6,161

 

4,407

 

Diagnostics

 

530

 

(824

)

541

 

(737

)

Total segment Adjusted EBITDA

 

3,747

 

975

 

6,702

 

3,670

 

 

Adjusted EBITDA from our pharmaceutical segment for the three and six months ended June 30, 2020 were €1,799 thousand and €4,407 thousand, respectively, representing decreases of €1,418 thousand and €1,754 thousand, respectively, as compared to €3,217 thousand and €6,161 thousand, respectively, for the three and six months ended June 30, 2019. The decreases were primarily attributable to the decrease in revenues from the pharmaceutical segment, as well as the increase in cost of sales and the continuous expansion of our business development team.

 

Adjusted EBITDA from our diagnostics segment for the three months ended June 30, 2020, was negative €824 thousand, a decrease of €1,354 thousand as compared to €530 thousand for the three months ended June 30, 2019. The decrease is mainly due to decreases in revenues during the period.  Adjusted EBITDA from our diagnostics segment for the six months ended June 30, 2020, was negative €737 thousand, a decrease of €1,278 thousand as compared to €541 thousand for the six months ended June 30, 2019, mainly attributable to increased expected credit loss allowances on trade receivables and contract assets recognized during the period.

 


 

Liquidity and Capital Resources

 

Our cash requirements are principally for working capital and capital expenditures, including expansions and improvements to our laboratory facilities, technology infrastructure and research and development activities. For the remaining period of 2020 and beyond, we anticipate that our capital expenditures will increase from prior periods as we continue to increase our research and development efforts. Our main source of liquidity has been our secured loans, municipal loans and government funding of research programs as well as the proceeds from our initial public offering.

 

In July 2020, we completed the Follow-on Equity Offering and received net offering proceeds, after deducting underwriting discounts and commissions, of €24 million.

 

However, our financial condition and liquidity are and will continue to be influenced by a variety of factors, including our ability to continue to generate cash flows from our operations, our capital expenditure requirements, and the impact of the COVID-19 pandemic on financial markets and the global economy.

 

Our known material liquidity needs for periods beyond the next twelve months are described below under “Contractual Obligations and Commitment”.   We believe that our existing cash and cash equivalents and proceeds from the Follow-on Equity Offering will enable us to fund our operating expenses and capital expenditure requirements for more than 12 months.

 

Comparative Cash Flows

 

The table below summarizes our consolidated statement of cash flows for the six months ended June 30, 2020 and 2019:

 

 

 

For the Six Months
Ended June 30,

 

 

 

2019

 

2020

 

 

 

(unaudited,
€ in thousands)

 

Consolidated statement of cash flows:

 

 

 

 

 

Cash flow used in operating activities

 

(1,907

)

(14,636

)

Cash flow used in investing activities

 

(3,603

)

(6,634

)

Cash flow used in financing activities

 

(148

)

(2,425

)

Net decrease in cash and cash equivalents

 

(5,658

)

(23,695

)

Cash and cash equivalents at the beginning of the period

 

9,222

 

41,095

 

Cash and cash equivalents at the end of the period

 

3,564

 

17,400

 

 

Operating Activities

 

Our cash flow used in operating activities primarily relates to changes in the components of our working capital, including cash received from our pharmaceutical partners and diagnostics clients, and payments made to our suppliers.

 

For the six months ended June 30, 2020, cash used in operating activities was €14,636 thousand, an increase of €12,729 thousand as compared to €1,907 thousand for the six months ended June 30, 2019. This change was principally due to the increase in losses incurred for the period.  In addition, to ensure we can continue to operate without being potentially affected by the COVID-19 pandemic limitations of our suppliers, we have purchased additional inventories for both COVID-19 tests and our core genetic testing, reflected in the increase in inventories by €6,252 thousand to €8,061 thousand as of June 30, 2020, from €1,809 thousand as of December 31, 2019.

 

Investing Activities

 

Our cash flow used in investing activities consists of investments in intangible assets, plant, property and equipment and right-of-use assets, as well as grants received for investments in property, plant and equipment.

 

The increase is mainly due to investments made in respect of COVID-19 testing during the period of €2.5 million, of which approximately €1.9 million and €0.6 million, respectively, are included in property, plant and equipment and right-of-use assets.

 


 

Financing Activities

 

Our cash flow used in financing activities consists of repayment of secured bank loans related to the construction of our new facility in Rostock, repayment of lease liabilities and interest expenses, net of the overdraft facility drawn during the period.

 

The increase is mainly due to the decrease in overdraft drawn in the six months ended June 30, 2020 by €900 thousand as compared to the six months ended June 30, 2019.  Cash used in financing activities included also repayment of lease liabilities of €1,619 thousand for the six months ended June 30, 2020, an increase of €970 thousand as compared to repayment of €649 thousand for the six months ended June 30, 2019.

 

Off-Balance Sheet Arrangements

 

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

 

Contractual Obligations and Commitments

 

The table below presents the residual contractual terms of the financial liabilities, including estimated interest payments. The figures are undiscounted gross amounts, including estimated interest payments and interest on undrawn loan funds as of June 30, 2020, but without showing the impact of offsetting.

 

 

 

 

 

 

 

Payments due by Period

 

 

 

Carrying
amount

 

Total
contractual
cashflow

 

Less than
1 year

 

Between 1
and
3 years

 

Between 3
and
5 years

 

More than
5 years

 

 

 

 

 

 

 

(unaudited,
€ in thousands)

 

Secured bank loans

 

1,369

 

1,421

 

844

 

577

 

 

 

Bank overdraft

 

3,127

 

3,127

 

3,127

 

 

 

 

Other bank loans(1)

 

438

 

438

 

438

 

 

 

 

Lease liabilities(2)

 

22,359

 

26,656

 

4,335

 

6,870

 

3,785

 

11,666

 

Trade payables

 

8,828

 

8,828

 

8,828

 

 

 

 

Total

 

36,121

 

40,470

 

17,572

 

7,447

 

3,785

 

11,666

 

 


(1)         On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed into law in the United States, which was a stimulus bill intended to bolster the U.S. economy, among other things, and provide assistance to qualifying businesses and individuals. The CARES Act included an infusion of funds into the healthcare system, and in May 2020, we received USD 475,000 as part of this initiative. This payment was recognized in short term current loans as of June 30, 2020. At this time, we are not certain of the availability, extent or impact of any future relief provided under the CARES Act.

 

(2)         Lease liabilities include leases related to lease contracts for land and buildings, offices, as well as various items including motor vehicles and other equipment which are accounted for according to IFRS 16, and measured at the present value of lease payments over the lease term at the commencement date of the leases.

 

In addition, to the contractual obligations disclosed above, we also have various lease contracts in relation to the expansion of our Rostock headquarters and the Frankfurt laboratory that had not yet commenced as at June 30, 2020. The future lease payments and utilities for these non-cancellable lease contracts are €32 thousand within one year, €1,218 thousand within five years and €5,324 thousand thereafter as at June 30, 2020.

 

We also have various non-cancellable lease contracts of office equipment and storage spaces which had a lease term of less than 12 months or were related to leases of low-value assets, and therefore the short-term lease recognition exemption was applied to these contracts. The future lease payments for these non-cancellable lease contracts are €75 thousand within one year and €23 thousand within five years as at June 30, 2020.

 

As of June 30, 2020, we had concluded agreements with suppliers, for goods and services to be provided subsequent to June 30, 2020, with a total payment obligation of approximately €6,172 thousand.

 

For further information on our material loan agreements, please see “Item 5. Operating and Financial Review and Prospects—F. Tabular Disclosure of Contractual Obligations” in our Annual Report.

 


 

Critical Accounting Policies and Estimates

 

There have been no material changes to the critical accounting policies and estimates described in “Item 5. Operating and Financial Review and Prospects—H. Critical Accounting Policies and Estimates” in our Annual Report.

 

JOBS Act Exemption

 

As a company with less than US$1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the JOBS Act. As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting. This exemption will apply for a period of five years following the completion of our initial public offering (November 6, 2019) or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier. We would cease to be an emerging growth company if we have more than US$1.07 billion in annual revenue, have more than US$700 million in market value of our common shares held by non-affiliates or issue more than US$1.0 billion of non-convertible debt over a three-year period.

 

Cautionary Statement Regarding Forward Looking Statements

 

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the heading “Risk Factors” in our Annual Report, Form 6-K containing our financial results for the three months ended March 31, 2020, filed with the SEC on June 15, 2020, and other current reports and documents filed with the SEC.  These risks and uncertainties include factors relating to:

 

·                  our ability to effectively manage our future growth and to execute our business strategy;

 

·                  our ability to generate sufficient revenue from our relationships with our pharmaceutical partners and clients, and to otherwise maintain our current relationships, or enter into new relationships, with pharmaceutical partners and clients;

 

·                  the effects of the COVID-19 pandemic on our business, financial position and results of operations;

 

·                  economic, political or social conditions and the effects of these conditions on our pharmaceutical partners’ and diagnostics clients’ businesses and levels of business activity;

 

·                  our expectations for our products and solutions achieving commercial market acceptance, and our ability to keep pace with the rapidly evolving industry in which we operate;

 

·                  our assumptions regarding market size in the rare disease industry and our growth potential;

 

·                  our pharmaceutical partners’ and clients’ need for rare disease information products and solutions and any perceived advantage of our products over those of our competitors;

 

·                  our ability to manage our international expansion, including our exposure to new and complex business, regulatory, political, operational, financial, and economic risks, and numerous and conflicting legal and regulatory requirements;

 

·                  our continued reliance on our senior management team, in particular our CEO, and other qualified personnel and our ability to retain such personnel;

 

·                  our ability to obtain, maintain, protect and enforce sufficient patent and other intellectual property protection for any products or solutions we develop and for our technology;

 

·                  the ongoing protection of our trade secrets, know-how, and other confidential and proprietary information;

 

·                  our ability to remediate our material weakness on internal control over financial reporting;

 

·                  general economic, political, demographic and business conditions in North America, the Middle East, Europe and other regions in which we operate;

 

·                  changes in government and industry regulation and tax matters;

 


 

·                  other factors that may affect our financial condition, liquidity and results of operations; and

 

·                  other risk factors discussed under “Item 3. Key Information—D. Risk Factors” in our Annual Report.

 

You should refer to the section in our Annual Report titled “Risk Factors”, Form 6-K containing our financial results for the three months ended March 31, 2020, filed with the SEC on June 15, 2020, and other current reports and documents filed with the SEC, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements included herein or incorporated by reference herein will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. The Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act do not protect any forward-looking statements that we make in connection with this offering.