Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused
on generating data-driven insights to diagnose, understand, and
treat rare diseases, today announced financial results for the
third quarter ended September 30, 2021, and provided a recent
business update.
Executive Commentary
“We are encouraged by the progress achieved in Q3 on our
continued path to return focus and growth to our rare disease
business, driving strategic Core Business execution,” stated Andrin
Oswald, M.D., Chief Executive Officer at CENTOGENE. “We saw
continued recovery trends in the Diagnostics segment, with over 40%
increase in revenues compared to Q3 2020. While recovery in Pharma
revenues is lagging, we remain optimistic for acceleration in the
fourth quarter, given the ongoing growth in signed contract value
as our new management team gains traction with current and
prospective Pharma partners.”
Q3 Financial Highlights
- Overall revenues of €30.2 million in Q3 2021, a 17% decrease
compared to €36.3 million in Q3 2020
- Revenues from the Company’s Pharma and Diagnostics segments
(“Core Business”) increased 13%, including Diagnostics revenues
(excl. COVID) of €7.3 million, an increase of 43% compared to €5.1
million in Q3 2020, and Pharma revenues of €2.7 million in Q3 2021,
a decrease of 28% compared to €3.8 million in Q3 2020
- Commercial COVID-19 testing revenues of €20.2 million in Q3
2021, down from €27.4 million in Q3 2020
- Total segment adjusted EBITDA of €(2.5) million compared to
€9.2 million in Q3 2020 from the Company’s Pharma, Diagnostics, and
COVID-19 testing segments, mainly reflecting the adjusted EBITDA
contribution from COVID-19 testing having decreased by €13.4
million compared to the same quarter last year, partially offset by
stronger adjusted EBITDA contribution from the Core Business
segments
- Cash and cash equivalents of €25.7 million as of September 30,
2021, compared to €34.8 million for the period ending June 30,
2021. There is uncertainty about the Company's ability to continue
as a going concern. Please refer to the Company's Q3 2021 interim
financial statements and related disclosures.
“While the business team’s full focus is on the Core Business,
we are also prudently managing the phaseout of our ancillary
COVID-19 testing business. We will leverage this process to also
streamline the operational footprint for the Core Business and
fully align with the strategic framework unveiled to the
shareholders in June. This is expected to lead to savings of up to
EUR 15 million annualized excluding restructuring costs,
predominantly reflecting a reduction in personnel-related and
operational expenditures and will reduce the Company’s cash burn
rate,” added René Just, Chief Financial Officer of CENTOGENE.
Recent Business Highlights
Corporate
- Added approximately 22,000 individuals to rare disease-centric
Bio/Databank in Q3 2021. This is a one-of-a-kind real-world data
repository which includes samples as well as data and cell lines
for rare diseases from patients from over 120 countries
- Published a
research study in the New England Journal of Medicine highlighting
ground-breaking family genetic research and path to a potential
cure for structural birth defects. The study utilized insights
gained from CENTOGENE’s Bio/Databank as part of a
cross-organizational international team that analyzed data of more
than 20,000 families. The findings provide a deeper understanding
of syndromic structural birth defects and pave the way to advancing
pharmacological treatment for the approximately 4 million infants
every year that are born with these types of defects
- Authored nine
peer-reviewed scientific publications in Q3 2021, focused on
generating critical insights into an array of diseases, including
Parkinson’s disease, as well as structural birth defects
Pharma
- Enrolled first patient in
frontotemporal dementia (FTD) clinical study, which aims to enroll
and complete data-rich genetic testing for more than 3,000 FTD
patients at participating centers in Belgium, Germany, Greece,
Italy, Portugal, Spain, and Turkey. The observational EFRONT Study
is being conducted with support from Alector, Inc. Patients
displaying the progranulin gene mutation (FTD-GRN) will have the
option to enroll in Alector’s Phase 3 INFRONT-3 clinical trial
- Expanded partnership with Agios
Pharmaceuticals, Inc. to generate novel insights into rare blood
diseases. CENTOGENE will provide genetic testing and clinical trial
support via a three-year fee-for-service agreement for Agios’ three
global, pivotal trials in thalassemia and sickle cell disease
- Currently leading 12 observational
longitudinal clinical studies to validate/monitor biomarkers,
covering several disease categories, such as Parkinson’s disease,
transthyretin amyloidosis, and inborn errors of metabolism
Diagnostic
- Reported order intake of 14,770,
which represents a 46% increase compared to 10,150 in the same
period in 2020
- Combined the Company’s expertise with Twist Bioscience to
develop advanced sequencing tools to make genetic testing rapidly
accessible for more patients with rare diseases
COVID-19 Testing & Organizational
footprint
- Leveraged CENTOGENE’s diagnostic
expertise and resources with continued COVID-19 testing, including
the processing of 342,300 test requests for SARS-CoV-2 testing in
Q3 2021
- Announced the phasing out of the
non-core COVID-19 testing services by early 2022 and alignment of
Company’s operational footprint with the strategic priorities on
Core Business execution. As part of this restructuring, the Company
will be eliminating approximately 80 positions in its Core Business
employee base, which had a baseline of approximately 530 at the end
of September 2021
2021 Financial Guidance
The Company updated its overall topline guidance and expects
total revenue growth for FY2021 between 30-40% versus the prior
year, driven mainly by COVID-19 related revenues. The portion of
total revenues derived from COVID-19 testing has declined over the
past three quarters and is expected to decline further in the
fourth quarter – leading to a phaseout by the end of Q1 2022. After
a decline of 20% from FY2019 to FY2020, the Company expects its
Core Business to return to growth for FY2021 in the mid to high
single digits.
Webcast and Conference Call Information
Management will host a conference call and webcast today at 2
p.m. CET/8 a.m. ET on November 24, 2021, to discuss financial
results and recent developments. To access the conference call and
webcast, please register at:
http://emea.directeventreg.com/registration/6469305
Upon registering, each participant will be provided with
Participant Dial-in information, a Direct Event Passcode, and a
unique Registrant ID. Registrants can then join up to 10 minutes
prior to the start of the call.
The webcast of the conference call and the slide deck will also
be available on the Investor Relations page of the Company’s
website at http://investors.centogene.com.
These results reflect another step forward for CENTOGENE’s
mission to enable the cure of 100 rare diseases within the next 10
years. To learn more, visit:
https://www.centogene.com/virtual-investor-event
About CENTOGENE
CENTOGENE engages in diagnosis and research around rare diseases
transforming real-world clinical, genetic, and multiomic data to
diagnose, understand, and treat rare diseases. 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 and data. CENTOGENE has developed a global proprietary
rare disease platform based on our real-world data repository of
over 600,000 patients representing over 120 different
countries.
The Company’s platform includes epidemiologic, phenotypic, and
genetic data that reflects a global population, as well as a
biobank of patients’ blood samples and cell cultures. CENTOGENE
believes this represents the only platform focused on comprehensive
analysis of multi-level data to improve the understanding of rare
hereditary diseases. It allows for better identification and
stratification of patients and their underlying diseases to enable
and accelerate discovery, development, and access to orphan drugs.
As of December 31, 2020, the Company collaborated with over 30
pharmaceutical partners.
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Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the U.S. federal securities laws. Statements
contained herein that are not clearly historical in nature are
forward-looking, and the words “anticipate,” “believe,”
“continues,” “expect,” “estimate,” “intend,” “project,” and similar
expressions and future or conditional verbs such as “will,”
“would,” “should,” “could,” “might,” “can,” and “may,” are
generally intended to identify forward-looking statements. Such
forward-looking statements involve known and unknown risks,
uncertainties, and other important factors that may cause
CENTOGENE’s actual results, performance, or achievements to be
materially different from any future results, performance, or
achievements expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others,
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 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, our ability to streamline cash usage, our requirement for
additional financing and our ability to continue as a going
concern, or other factors. For further information on the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to CENTOGENE’s business in general, see CENTOGENE’s risk
factors set forth in CENTOGENE’s Form 20-F filed on April 15, 2021,
with the Securities and Exchange Commission (the “SEC”) and
subsequent filings with the SEC. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and CENTOGENE’s specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events, or otherwise.
Centogene N.V.Unaudited interim
condensed consolidated statements of comprehensive loss
for the three and nine months ended September 30, 2021, and
2020(in EUR k)
|
|
|
|
For the three months ended September 30 |
|
For the nine months ended September 30 |
|
|
Note |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue |
|
4, 5 |
|
30,196 |
|
|
36,305 |
|
|
147,027 |
|
|
58,129 |
|
Cost of sales |
|
|
|
35,618 |
|
|
26,059 |
|
|
131,325 |
|
|
39,892 |
|
Gross (loss)/
profit |
|
|
|
(5,422 |
) |
|
10,246 |
|
|
15,702 |
|
|
18,237 |
|
Research and development
expenses |
|
|
|
3,821 |
|
|
4,796 |
|
|
12,209 |
|
|
10,606 |
|
General administrative
expenses |
|
|
|
10,406 |
|
|
8,373 |
|
|
32,496 |
|
|
24,038 |
|
Selling expenses |
|
|
|
2,206 |
|
|
1,300 |
|
|
6,097 |
|
|
6,012 |
|
Impairment of financial
assets |
|
7 |
|
502 |
|
|
1,147 |
|
|
1,177 |
|
|
2,821 |
|
Other operating income |
|
6.1 |
|
1,011 |
|
|
679 |
|
|
2,653 |
|
|
2,425 |
|
Other operating expenses |
|
6.2 |
|
— |
|
|
53 |
|
|
36 |
|
|
191 |
|
Operating
loss |
|
|
|
(21,346 |
) |
|
(4,744 |
) |
|
(33,660 |
) |
|
(23,006 |
) |
Interest and similar income |
|
|
|
— |
|
|
— |
|
|
— |
|
|
6 |
|
Interest and similar expense |
|
|
|
263 |
|
|
793 |
|
|
734 |
|
|
1,504 |
|
Financial costs, net |
|
|
|
(263 |
) |
|
(793 |
) |
|
(734 |
) |
|
(1,498 |
) |
Loss before
taxes |
|
|
|
(21,609 |
) |
|
(5,537 |
) |
|
(34,394 |
) |
|
(24,504 |
) |
Income tax expenses |
|
|
|
35 |
|
|
103 |
|
|
159 |
|
|
232 |
|
Loss for the
period |
|
|
|
(21,644 |
) |
|
(5,640 |
) |
|
(34,553 |
) |
|
(24,736 |
) |
Other comprehensive income/
(loss), all attributable to equity holders of the parent |
|
|
|
86 |
|
|
(66 |
) |
|
16 |
|
|
4 |
|
Total comprehensive
loss |
|
|
|
(21,558 |
) |
|
(5,706 |
) |
|
(34,537 |
) |
|
(24,732 |
) |
Attributable to: |
|
|
|
|
|
|
|
|
|
|
Equity holders of the parent |
|
|
|
(21,610 |
) |
|
(5,708 |
) |
|
(34,635 |
) |
|
(24,671 |
) |
Non‑controlling interests |
|
|
|
52 |
|
|
2 |
|
|
98 |
|
|
(61 |
) |
|
|
|
|
(21,558 |
) |
|
(5,706 |
) |
|
(34,537 |
) |
|
(24,732 |
) |
Loss per share - Basic
and diluted (in EUR) |
|
|
|
(0.96 |
) |
|
(0.27 |
) |
|
(1.55 |
) |
|
(1.20 |
) |
The accompanying notes form an integral part of these unaudited
interim condensed consolidated financial statements
Centogene N.V.Unaudited interim
condensed consolidated statements of financial position
as at September 30, 2021, and December 31,
2020(in EUR k)
Assets |
|
Note |
|
Sep 30, 2021 |
|
Dec 31, 2020 |
Non‑current
assets |
|
|
|
|
|
|
Intangible assets |
|
|
|
11,407 |
|
12,407 |
Property, plant and equipment |
|
|
|
12,160 |
|
16,590 |
Right-of-use assets |
|
|
|
19,241 |
|
22,120 |
Other assets |
|
7 |
|
2,973 |
|
1,967 |
|
|
|
|
45,781 |
|
53,084 |
Current
assets |
|
|
|
|
|
|
Inventories |
|
|
|
4,922 |
|
11,405 |
Trade receivables and contract assets |
|
7 |
|
13,907 |
|
29,199 |
Other assets |
|
7 |
|
5,848 |
|
8,286 |
Cash and cash equivalents |
|
8 |
|
25,732 |
|
48,156 |
|
|
|
|
50,409 |
|
97,046 |
|
|
|
|
96,190 |
|
150,130 |
Equity and liabilities |
|
Note |
|
Sep 30, 2021 |
|
Dec 31, 2020 |
Equity |
|
|
|
|
|
|
Issued capital |
|
9 |
|
2,701 |
|
|
2,654 |
|
Capital reserve |
|
9 |
|
132,005 |
|
|
125,916 |
|
Retained earnings and other reserves |
|
|
|
(97,523 |
) |
|
(62,888 |
) |
Non‑controlling interests |
|
|
|
193 |
|
|
95 |
|
|
|
|
|
37,376 |
|
|
65,777 |
|
Non‑current
liabilities |
|
|
|
|
|
|
Non‑current loans |
|
10.1 |
|
100 |
|
|
401 |
|
Lease liabilities |
|
10.1 |
|
15,560 |
|
|
17,677 |
|
Deferred tax liabilities |
|
|
|
248 |
|
|
207 |
|
Government grants |
|
10.2 |
|
8,228 |
|
|
8,950 |
|
|
|
|
|
24,136 |
|
|
27,235 |
|
Current
liabilities |
|
|
|
|
|
|
Government grants |
|
10.2 |
|
1,375 |
|
|
1,342 |
|
Current loans |
|
10.1 |
|
3,842 |
|
|
2,492 |
|
Lease liabilities |
|
10.1 |
|
3,221 |
|
|
3,528 |
|
Trade payables |
|
10.2 |
|
8,810 |
|
|
31,736 |
|
Liabilities from income taxes |
|
10.2 |
|
177 |
|
|
58 |
|
Other liabilities |
|
10.2 |
|
17,253 |
|
|
17,962 |
|
|
|
|
|
34,678 |
|
|
57,118 |
|
|
|
|
|
96,190 |
|
|
150,130 |
|
The accompanying notes form an integral part of these unaudited
interim condensed consolidated financial statements
Centogene N.V.Unaudited interim
condensed consolidated statements of cash flows
for the nine months ended September 30, 2021, and
2020(in EUR k)
|
|
|
|
For the nine months ended September 30 |
|
|
Note |
|
2021 |
|
2020 |
Operating
activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
|
|
(34,394 |
) |
|
(24,504 |
) |
|
|
|
|
|
|
|
Adjustments to
reconcile loss to cash flow from operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
5 |
|
13,476 |
|
|
6,943 |
|
Inventory write-off |
|
|
|
1,795 |
|
|
— |
|
Interest income |
|
|
|
— |
|
|
(6 |
) |
Interest expense |
|
|
|
734 |
|
|
1,504 |
|
Loss on the disposal of property, plant and equipment |
|
|
|
352 |
|
|
— |
|
Expected credit loss allowances on trade receivables and contract
assets |
|
7 |
|
1,177 |
|
|
2,821 |
|
Share‑based payment expenses |
|
11 |
|
6,136 |
|
|
2,542 |
|
Tax expense |
|
|
|
160 |
|
|
— |
|
Other non‑cash items |
|
|
|
(300 |
) |
|
(1,800 |
) |
|
|
|
|
|
|
|
Changes in operating
assets and liabilities |
|
|
|
|
|
|
Inventories |
|
|
|
4,688 |
|
|
(5,482 |
) |
Trade receivables and contract assets |
|
7 |
|
14,115 |
|
|
(12,015 |
) |
Other assets |
|
7 |
|
594 |
|
|
5,605 |
|
Trade payables |
|
10.2 |
|
(22,926 |
) |
|
3,498 |
|
Other liabilities |
|
10.2 |
|
(590 |
) |
|
1,225 |
|
|
|
|
|
|
|
|
Cash flow used in
operating activities |
|
|
|
(14,983 |
) |
|
(19,669 |
) |
|
|
|
|
|
|
|
Investing
activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for investments in
intangible assets |
|
5 |
|
(2,567 |
) |
|
(4,781 |
) |
Cash paid for investments in
property, plant and equipment |
|
5 |
|
(2,829 |
) |
|
(6,641 |
) |
Grants received for investment
in property, plant and equipment |
|
10.2 |
|
— |
|
|
390 |
|
Interest received |
|
|
|
— |
|
|
6 |
|
|
|
|
|
|
|
|
Cash flow used in
investing activities |
|
|
|
(5,396 |
) |
|
(11,026 |
) |
|
|
|
|
|
|
|
Financing
activities |
|
|
|
|
|
|
Cash received from issuance of
shares |
|
|
|
— |
|
|
22,430 |
|
Cash paid for acquisition of
non-wholly owned subsidiary |
|
|
|
— |
|
|
(75 |
) |
Cash received from loans |
|
10.1 |
|
1,910 |
|
|
1,114 |
|
Cash repayments of loans |
|
10.1 |
|
(467 |
) |
|
(1,260 |
) |
Cash repayments of lease
liabilities |
|
10.1 |
|
(3,301 |
) |
|
(2,833 |
) |
Interest paid |
|
|
|
(187 |
) |
|
(1,028 |
) |
|
|
|
|
|
|
|
Cash flow used in/
generated from financing activities |
|
|
|
(2,045 |
) |
|
18,348 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in cash and cash
equivalents |
|
|
|
(22,424 |
) |
|
(12,347 |
) |
Cash and cash equivalents at
the beginning of the period |
|
|
|
48,156 |
|
|
41,095 |
|
Cash and cash equivalents at
the end of the period |
|
|
|
25,732 |
|
|
28,748 |
|
The accompanying notes form an integral part of these unaudited
interim condensed consolidated financial statements
Reconciliation of Segment Adjusted EBITDA to Group Loss
for the Period
|
|
|
|
|
For the three months ended September 30 |
|
2021 |
|
|
2020 |
|
Reported segment Adjusted EBITDA |
|
(2,545 |
) |
|
9,177 |
|
Corporate expenses |
|
(10,135 |
) |
|
(10,261 |
) |
|
|
(12,680 |
) |
|
(1,084 |
) |
Share-based payment expenses (Note 11) |
|
(1,860 |
) |
|
(1,149 |
) |
Depreciation and amortization |
|
(6,806 |
) |
|
(2,511 |
) |
Operating loss |
|
(21,346 |
) |
|
(4,744 |
) |
Financial costs, net |
|
(263 |
) |
|
(793 |
) |
Income tax expenses |
|
(35 |
) |
|
(103 |
) |
Loss for the three months ended
September 30 |
|
(21,644 |
) |
|
(5,640 |
) |
For the nine months ended September 30 |
|
2021 |
|
|
2020 |
|
Reported segment Adjusted EBITDA |
|
17,650 |
|
|
12,848 |
|
Corporate expenses |
|
(31,698 |
) |
|
(26,369 |
) |
|
|
(14,048 |
) |
|
(13,521 |
) |
Share-based payment expenses (Note 11) |
|
(6,136 |
) |
|
(2,542 |
) |
Depreciation and amortization |
|
(13,476 |
) |
|
(6,943 |
) |
Operating loss |
|
(33,660 |
) |
|
(23,006 |
) |
Financial costs, net |
|
(734 |
) |
|
(1,498 |
) |
Income tax expenses |
|
(159 |
) |
|
(232 |
) |
Loss for the nine months ended
September 30 |
|
(34,553 |
) |
|
(24,736 |
) |
|
|
|
|
|
|
|
Media Contact:CENTOGENELennart
StreibelInvestor RelationsInvestor.Relations@centogene.com
Ben LeggCorporate
CommunicationsBen.Legg@centogene.com Stern
IRBrendan Payne+1 (212) 698
8695brendan.payne@sternir.com
Centogene NV (NASDAQ:CNTG)
Historical Stock Chart
From Apr 2024 to May 2024
Centogene NV (NASDAQ:CNTG)
Historical Stock Chart
From May 2023 to May 2024