EX-99.1 2 dp117259_ex9901.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Cambridge, MA, USA & Rostock, Berlin, GERMANY, December 5, 2019 – CENTOGENE N.V. (Nasdaq: CNTG), 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, announced today a corporate update and reported financial results for the third quarter and the nine months ended September 30, 2019.

 

 

Recent Corporate Highlights

 

·On November 7, 2019, Centogene completed a corporate reorganization in connection with an initial public offering in the United States, and Centogene N.V. (“the Company”) became the holding company of Centogene AG, and the ultimate parent company of the group. On the same day, Centogene N.V.’s shares began trading on the Nasdaq Global Market, after pricing an initial public offering of 4,000,000 common shares at $14.00 per common share, raising net proceeds of approximately $47.1 million, after deducting underwriting discounts, commission and other expenses

·Continued expansion of collaborations with existing and new pharmaceutical partners, including a data access and collaboration agreement with Pfizer Inc. (NYSE: PFE) announced on November 13, 2019

·Continued expansion of global proprietary rare disease platform with approximately 2.1 billion weighted data points, from approximatively 465,000 patients representing 120 different countries as of September 30, 2019

·Completion of sale and leaseback transaction of our Rostock, Germany headquarters in July 2019

 

“CENTOGENE made solid progress so far in 2019. The recent data access and collaboration agreement with Pfizer Inc. announced on November 13, 2019 further acknowledges the value attributed to our global rare disease repository.” said Arndt Rolfs, CEO of CENTOGENE, “With the proceeds from the IPO, we will continue the momentum of our research and development programs to further support the orphan drug development of our pharmaceutical partners, and continue to provide valuable diagnostic testing to rare disease patients. We have a life-long commitment to our patients.”

 

 

 

Nine months ended September 30, 2019 and Q3 2019 Financial Highlights

 

Cash and Cash Equivalents

 

Cash and cash equivalents as of September 30, 2019, were € 6.1 million, compared to € 9.2 million as of December 31, 2018.

 

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 nine months ended September 30, 2019 was € 33.6 million, an increase of approximately € 3.2 million, or 10% as compared to the same period in 2018. Revenue from our pharmaceutical segment was € 13.5 million for the nine months ended September 30, 2019, similar to that of the prior year period, while the revenue from our diagnostics segment was € 20 million for the nine months ended September 30, 2019, an increase of approximately € 3.1 million, or 19% as compared to that of the prior year period.

 

Total revenue was € 11.6 million for the three months ended September 30, 2019, a decrease of approximately € 1.7 million, or 13% as compared to the prior year period. Revenue from our pharmaceutical segment for the three months ended September 30, 2019 were € 4.8 million, a decrease of approximately € 2.4 million, or 33% as compared to the prior year period. The non-recurring revenue in the third quarter of 2018 consisted of upfront payments totaling € 4.0 million related to the entry into collaboration agreements with Evotec International GmbH and Denali Therapeutics Inc. The decrease in revenues for the three months ended September 30, 2019 when compared to the same prior year period, was mainly driven by this non-recurring revenue.

 

Revenue from our diagnostics segment for the three months ended September 30, 2019 was € 6.8 million, an increase of approximately € 0.7 million, or 11% as compared to the same period in 2018. Our diagnostics revenue for the three months ended September 30, 2019 was split into approximately 51% from whole exome sequencing (WES) and whole genome sequencing (WGS, or sequencing with high volume of data), 40% from standard genetic testing (which includes our single gene, CNV and mutation quantification products) and panel sequencing and 9% from non-invasive prenatal testing (NIPT).

 

Research and development expenses (“R&D”)

 

Our R&D expenses for the three months ended September 30, 2019 were € 2.0 million, an increase of approximately € 0.6 million, or 41% as compared to the prior year period. The increase is primarily attributed to expenses associated with the expansion of our proprietary information platform, as well as development of new products and solutions.

 

Our R&D expenses for the nine months ended September 30, 2019 were € 6.1 million, an increase of approximately € 2.3 million, or 62% as compared to the prior year period.

 

General administrative expenses (“G&A”)

 

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Our G&A expenses for the three months ended September 30, 2019 were € 4.9 million, a decrease of approximately € 0.6 million, or 11% as compared to the prior year period . The decrease is primarily attributed to a decrease in share-based compensation expenses. The share-based compensation expenses for the three months ended September 30, 2019 included in G&A expenses amounted to € 0.3 million, a decrease of € 1.9 million as compared to the prior year period.

 

Our G&A expenses for the nine months ended September 30, 2019 were € 16.5 million, an increase of approximately € 2.0 million, or 14% as compared to the prior year period. The increase is mainly attributable to an overall headcount increase and related costs as a result of business expansion, as well as an increase in IT infrastructure investment.

 

Comprehensive loss attributable to equity holders

 

Comprehensive loss attributable to equity holders for the three months ended September 30, 2019 was € 4.2 million or € 13 per share (basic and diluted based on 322,007 issued and outstanding common and preferred shares as of September 30, 2019), as compared to € 1.1 million or € 4 per share for the prior year period.

 

Comprehensive loss attributable to equity holders for the nine months ended September 30, 2019 was € 15.7 million or € 49 per share, as compared to € 7.5 million or € 29 per share for the prior year period.

 

Additional information regarding these financials is included in the notes to the interim condensed consolidated financial statements as of and for the three months and nine months ended September 30, 2019, which can be found by visiting EDGAR on the U.S. Securities and Exchange Commission website at www.sec.gov.

 

2019 Outlook

 

CENTOGENE has made solid progress in 2019. Our number of pharmaceutical partners have increased from 28 partners as of September 30, 2018 to 38 partners as of September 30, 2019, and over 10 new contracts have been signed with new and existing pharmaceutical partners in the nine months ended September 30, 2019. The recent data access and collaboration agreement with Pfizer Inc. announced on November 13, 2019 further acknowledges the value attributed to our global rare disease repository.

 

Looking forward, for full year 2019, we anticipate to have received over 130,000 order requests, allowing our data repository to grow to approximately 500,000 patients. We anticipate the total number of pharmaceutical partners to be over 40 partners by the end of 2019, and anticipate that revenue growth for full year 2019 will be approximately 20% when compared to full year 2018.

 

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Centogene A.G.

Interim condensed consolidated statements of comprehensive loss 

for the three and nine months ended September 30, 2018 and 2019

 

   For the three months ended
September 30,		  For the nine months ended
September 30,
   2018  2019  2018  2019
   (unaudited, € in thousands, except for loss per share)
Revenue    13,380    11,638    30,392    33,559 
Cost of sales    6,572    6,641    15,698    19,499 
Gross profit    6,808    4,997    14,694    14,060 
Research and development expenses    1,427    2,011    3,783    6,119 
General administrative expenses    5,493    4,884    14,523    16,487 
Selling expenses    1,791    1,788    4,639    6,144 
Other operating income    839    935    1,792    2,623 
Other operating expenses    68    92    733    556 
Real estate transfer tax expenses    —      —      —      1,200 
Operating loss    (1,132)   (2,843)   (7,192)   (13,823)
Interest and similar income    2    —      16    12 
Interest and similar expenses    247    1,433    933    1,865 
Finance costs, net    (245)   (1,433)   (917)   (1,853)
Loss before taxes    (1,377)   (4,276)   (8,109)   (15,676)
Income tax (benefits)/expenses    (152)   —      (262)   163 
Loss for the period    (1,225)   (4,276)   (7,847)   (15,839)
Other comprehensive (loss)/ income    (52)   (1)   (8)   9 
Total comprehensive loss for the period    (1,277)   (4,277)   (7,855)   (15,830)
Loss per share (Basic and Diluted)   (4)   (13)   (29)   (49)

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Centogene A.G.

Supplemental selected segment information 

for the three and nine months ended September 30, 2018 and 2019

 

   For the three months ended
September 30,		  For the nine months ended
September 30,
   2018  2019  2018  2019
   (unaudited, € in thousands)
Revenues by segment:            
Pharmaceutical    7,236    4,833    13,506    13,531 
Diagnostics    6,144    6,805    16,886    20,028 
Total Revenues    13,380    11,638    30,392    33,559 

 

   For the three months ended
September 30,		  For the nine months ended
September 30,
   2018  2019  2018  2019
   (unaudited, € in thousands)
Segment Adjusted EBITDA:            
Pharmaceutical    5,916    3,400    10,673    9,561 
Diagnostics    842    757    2,417    1,298 

 

Reconciliation of segment Adjusted EBITDA to Group loss for the period  For the three months ended
September 30,		  For the nine months ended
September 30,
   2018  2019  2018  2019
   (unaudited, € in thousands)
Reported Segment Adjusted EBITDA    6,758    4,157    13,090    10,859 
Corporate expenses    (3,667)   (4,917)   (11,585)   (14,922)
    3,091    (760)   1,505    (4,063)
Share-based payment expenses    (2,779)   (471)   (5,051)   (5,299)
Depreciation and amortization    (1,444)   (1,612)   (3,646)   (4,461)
Operating loss    (1,132)   (2,843)   (7,192)   (13,823)
Finance costs, net    (245)   (1,433)   (917)   (1,853)
Income taxes benefits    152    —      262    (163)
Loss for the period    (1,225)   (4,276)   (7,847)   (15,839)

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Centogene A.G.

Interim condensed consolidated statements of financial position 

As at December 31, 2018 and September 30, 2019

 

Assets  Dec 31, 2018  Sep 30, 2019
   (unaudited, € in thousands)
Non-current assets      
Intangible assets    8,795    12,466 
Property, plant and equipment    39,115    9,369 
Right-of-use assets    —      19,094 
Other assets    —      3,000 
    47,910    43,929 
Current assets          
Inventories    1,346    1,586 
Trade receivables    10,901    13,683 
Other assets    7,295    8,528 
Cash and cash equivalents    9,222    6,061 
    28,764    29,858 
    76,674    73,787 

 

Equity and liabilities  Dec 31, 2018  Sep 30, 2019
Equity      
Issued capital    322    322 
Capital reserve    46,923    47,417 
Retained earnings and other reserves    (19,964)   (35,638)
Non-controlling interests    (757)   (913)
    26,524    11,188 
Non-current liabilities          
Non-current loans    12,915    2,029 
Lease liabilities    1,712    14,107 
Other liabilities    11,240    9,913 
    25,867    26,049 
Current liabilities          
Investment subsidies    794    1,288 
Current loans    3,702    4,262 
Lease liabilities    1,350    2,902 
Liabilities from income taxes    10    173 
Trade payables    5,429    8,709 
Other liabilities    12,998    19,216 
    24,283    36,550 
    76,674    73,787 

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Centogene A.G.

Interim condensed consolidated statements of cashflow 

for the nine months ended September 30, 2018 and 2019

 

   2018  2019
   (unaudited, € in thousands)
Loss before taxes    (8,109)   (15,676)
Amortization and depreciation    3,646    4,461 
Interest income    (16)   (12)
Interest expense    933    1,865 
Gain on the disposal of property, plant and equipment    —      (532)
Share-based payment expenses    5,051    5,299 
Real Estate transfer tax expenses    —      1,200 
Other non-cash items    (275)   (26)
Changes in operating assets and liabilities:          
Inventories    (969)   (240)
Trade receivables    (6,153)   (2,782)
Other assets    (1,089)   (739)
Trade payables    1,526    3,280 
Other liabilities    1,366    448 
Cash flow used in operating activities    (4,089)   (3,454)
           
Cash paid for investments in intangible assets    (2,485)   (5,366)
Cash paid for investments in property, plant and equipment    (6,737)   (1,266)
Grant received for investment in property, plant and equipment    2,184    341 
Cash received from disposal of property, plant and equipment    —      19,800 
Interest received    16    12 
Cash flow (used in)/generated from investing activities    (7,022)   13,521 
           
Cash received from equity contributions, net    10,098    —   
Cash received from loans    5,021    1,545 
Cash repayment of loans    (2,752)   (11,871)
Cash received from finance leases    —      470 
Cash repayments of financial leases/lease liabilities    (1,507)   (1,507)
Interest paid    (933)   (1,865)
Cash flow generated from/(used) in financing activities    9,927    (13,228)
           
Changes in cash and cash equivalents    (1,184)   (3,161)
Cash and cash equivalents at the beginning of the period    3,157    9,222 
Cash and cash equivalents at the end of the period    1,973    6,061 

 

Call Instructions

 

Centogene N.V. will host a conference call to discuss its third quarter 2019 results on Thursday, December 5, 2019 at 8 a.m. Eastern Time. The call on December 5, 2019 can be accessed by dialing U.S. toll free +1 866 966 1396 or U.K. +44 (0) 207 192 8000 up to ten minutes prior to the start of the call and providing the conference ID 3977687.

 

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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 is 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. The Company’s 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. Centogene has developed a global proprietary rare disease platform based on our real-world data repository with approximately 2.1 billion weighted data points from approximately 465,000 patients representing over 120 different countries as of September 30, 2019, or an average of over 500 data points per patient.

 

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 September 30, 2019, the Company collaborated with over 35 pharmaceutical partners for over 30 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, possible changes in current and proposed legislation, regulations and governmental 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

 

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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.

 

Certain information contained in this Press Release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company's own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this press release involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while the Company believes its own internal research is reliable, such research has not been verified by any independent source.

 

For further information, please refer to the Risk Factors section in our registration statement on form F-1, as amended (file no. 333-234177) 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.

 

Centogene Contact:

Sun Kim 

Chief Strategy and Investor Relations Officer

investor.relations@centogene.com

 

Media Contact: 

Ross Bethell

Director, Corporate Communications 

press@centogene.com

 

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