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
second quarter ended June 30, 2021, and provided an update on
recent business progress.
“We delivered a strong quarter and made meaningful progress on
our strategic priorities, which we outlined at our Investor Event
in June this year. This includes the appointment and onboarding of
an expanded new management team, with the most recent addition of
Patrice P. Denèfle as Chief Scientific Officer to help lead our
data-driven approach to reinvent rare disease drug discovery and
development,” stated Andrin Oswald, M.D., Chief Executive Officer
at CENTOGENE. “By leveraging the compounding value of our leading
and continuously growing Bio/Databank within our diagnostic,
research, and pharma initiatives, we have built a strong foundation
and are set to enable the cure of 100 rare diseases in 10
years.”
Q2 Financial Highlights
- Revenues of €51.9 million in Q2 2021, a 434% increase compared
to €9.7 million in Q2 2020; Revenues from the Company’s Pharma and
Diagnostics segments (“Core Business”) increased 25%
- Clinical Diagnostics revenues (excl. COVID) of €6.7 million, an
increase of 82% compared to €3.6 million in Q2 2020
- Pharma revenues of €2.8 million in Q2 2021, down from €3.9
million in Q2 2020, with further revenues weighted towards the end
of 2021
- Commercial COVID-19 testing revenues of €42.3 million in Q2
2021, up from €2.1 million in Q2 2020
- Positive total segment adjusted EBITDA of €7.5 million compared
to €1.0 million in Q2 2020 from the Company’s Pharma, Diagnostics,
and COVID-19 testing segments
- Cash and cash equivalents of €34.8 million as of June 30, 2021,
compared to €45.2 million for the period ending March 31, 2021
“We are very encouraged by the accelerating momentum and the
performance we delivered in Q2 2021, particularly in achieving
strong segment adjusted EBITDA now multiple quarters in a row,”
said René Just, Chief Financial Officer of CENTOGENE. “We will
continue to efficiently deploy our capabilities and resources to
drive further growth and value creation for our patients and
shareholders.”
Corporate Highlights
- Set mission to enable the cure of 100 rare diseases in 10 years
and outlined high value creating strategy and milestones for the
next few years at first corporate Investor Event on June 22,
2021
- Published 200th scientific publication – accelerating
scientific discoveries through leveraging CENTOGENE's vast
Bio/Databank and studying over 115,000 patient cases to diagnose,
understand, and treat rare disease patients around the world
- Added approximately 24,000 patients with high quality data sets
to CENTOGENE’s Bio/Databank, the world´s most geographically
diverse source of rare disease-centric insights
- Announced key additions to executive management team, including
most recently Patrice P. Denèfle as Chief Scientific Officer, who
is responsible for overseeing scientific activities to deliver on
the Company’s vision and strategy, while driving value
creation
Pharma Highlights
- Initiated new collaboration with immuno-neurology pioneer
Alector to accelerate the diagnosis of patients with frontotemporal
dementia, a genetic neurodegenerative disease
- Extended partnership with Takeda to enable access to genetic
testing and diagnosis of patients with certain genetic
disorders
- Extended global Parkinson’s disease study (Rostock
International Parkinson's Disease (ROPAD) Study) – aiming to
recruit and genetically test an additional 2,500 patients for
Parkinson’s, one of CENTOGENE’s key prioritized diseases. In 2018,
CENTOGENE entered into a strategic collaboration with Denali
Therapeutics for the targeted global identification and recruitment
of Parkinson’s disease patients with mutations in the LRRK2
gene
- Currently leads 12 ongoing observational and longitudinal
observational clinical studies to validate/monitor biomarkers,
covering several disease categories, such as Parkinson’s disease,
transthyretin amyloidosis, and inborn errors of metabolism
Diagnostic Highlights
- Launched enhanced Whole Exome Sequencing (WES) service NEW
CentoXome®, coupling insights from the Company’s unique rare
disease-centric Bio/Databank with superior omics technology to
increase diagnostic yield by up to 20% compared to conventional
WES
- Reported testing volume/order intake/test requests of 29,100
which represents a 54 % increase compared to 18,850 in the same
period in 2020
- Published latest research which led to the discovery of six new
rare diseases, which are now incorporated into the Company’s
diagnostic offering, and diagnosis of over 90 patients by
leveraging the Company’s Bio/Databank
- Authored 18 peer-reviewed scientific publications in Q2 2021,
focused on generating critical insights into diseases, including
Parkinson’s disease, as well as advancements in genetic sequencing
technology
COVID-19 Testing
- Leveraged CENTOGENE’s diagnostic expertise and resources with
continued COVID-19 testing, including the processing of 679,900
test requests for SARS-CoV-2 testing in Q2 2021
2021 Financial GuidanceThe
Company continues to see Diagnostics recovery, alongside momentum
in newly signed Pharma partnership deals. This trajectory indicates
a return to solid core business growth for 2021. Despite
anticipating COVID-19 revenues to decline in the second half of the
year, overall revenue for FY 2021 is expected to surpass FY
2020.
Webcast and Conference Call
InformationManagement will host a conference call and
webcast today at 2 p.m. CEST/ 8 a.m. EDT to discuss financial
results and recent developments. To access the conference call and
webcast, please register at:
http://emea.directeventreg.com/registration/6090847. Upon
registering, each participant will be provided with Participant
Dial In Numbers, 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 CENTOGENECENTOGENE
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 with
over 3.9 billion weighted data points from approximately 600,000
patients representing over 120 different countries as of December
31, 2020.
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.
Forward-Looking StatementsThis 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, 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 six months ended June 30, 2021, and
2020(in EUR k)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30 |
|
For the six months ended June 30 |
|
|
Note |
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
Revenue |
|
4, 5 |
|
9,719 |
|
|
51,871 |
|
|
21,824 |
|
|
116,831 |
|
Cost of sales |
|
|
|
6,815 |
|
|
43,760 |
|
|
13,833 |
|
|
95,707 |
|
Gross
profit |
|
|
|
2,904 |
|
|
8,111 |
|
|
7,991 |
|
|
21,124 |
|
Research and development
expenses |
|
|
|
3,119 |
|
|
4,053 |
|
|
5,810 |
|
|
8,388 |
|
General administrative
expenses |
|
|
|
7,767 |
|
|
10,494 |
|
|
15,665 |
|
|
22,090 |
|
Selling expenses |
|
|
|
2,386 |
|
|
1,942 |
|
|
4,712 |
|
|
3,891 |
|
Impairment of financial
assets |
|
7 |
|
500 |
|
|
580 |
|
|
1,674 |
|
|
675 |
|
Other operating income |
|
6.1 |
|
801 |
|
|
1,276 |
|
|
1,746 |
|
|
1,642 |
|
Other operating expenses |
|
6.2 |
|
37 |
|
|
2 |
|
|
138 |
|
|
36 |
|
Operating
loss |
|
|
|
(10,104 |
) |
|
(7,684 |
) |
|
(18,262 |
) |
|
(12,314 |
) |
Interest and similar income |
|
|
|
13 |
|
|
— |
|
|
13 |
|
|
— |
|
Interest and similar expense |
|
|
|
269 |
|
|
212 |
|
|
718 |
|
|
471 |
|
Financial costs, net |
|
|
|
(256 |
) |
|
(212 |
) |
|
(705 |
) |
|
(471 |
) |
Loss before
taxes |
|
|
|
(10,360 |
) |
|
(7,896 |
) |
|
(18,967 |
) |
|
(12,785 |
) |
Income tax expenses |
|
|
|
— |
|
|
124 |
|
|
129 |
|
|
124 |
|
Loss for the
period |
|
|
|
(10,360 |
) |
|
(8,020 |
) |
|
(19,096 |
) |
|
(12,909 |
) |
Other comprehensive income/
(loss), all attributable to equity holders of the parent |
|
|
|
(6 |
) |
|
(191 |
) |
|
70 |
|
|
(70 |
) |
Total comprehensive
loss |
|
|
|
(10,366 |
) |
|
(8,211 |
) |
|
(19,026 |
) |
|
(12,979 |
) |
Attributable to: |
|
|
|
|
|
|
|
|
|
|
Equity holders of the parent |
|
|
|
(10,364 |
) |
|
(8,222 |
) |
|
(18,963 |
) |
|
(13,025 |
) |
Non‑controlling interests |
|
|
|
(2 |
) |
|
11 |
|
|
(63 |
) |
|
46 |
|
|
|
|
|
(10,366 |
) |
|
(8,211 |
) |
|
(19,026 |
) |
|
(12,979 |
) |
Loss per share - Basic
and diluted (in EUR) |
|
|
|
(0.52 |
) |
|
(0.37 |
) |
|
(0.95 |
) |
|
(0.58 |
) |
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 December 31, 2020, and June 30,
2021(in EUR k)
|
|
|
|
|
|
|
|
Assets |
|
Note |
|
Dec 31, 2020 |
|
June 30, 2021 |
|
Non‑current
assets |
|
|
|
|
|
|
|
Intangible assets |
|
|
|
12,407 |
|
12,179 |
|
Property, plant and equipment |
|
|
|
16,590 |
|
16,411 |
|
Right-of-use assets |
|
|
|
22,120 |
|
20,558 |
|
Other assets |
|
7 |
|
1,967 |
|
3,023 |
|
|
|
|
|
53,084 |
|
52,171 |
|
Current
assets |
|
|
|
|
|
|
|
Inventories |
|
|
|
11,405 |
|
9,281 |
|
Trade receivables and contract assets |
|
7 |
|
29,199 |
|
18,490 |
|
Other assets |
|
7 |
|
8,286 |
|
6,064 |
|
Cash and cash equivalents |
|
8 |
|
48,156 |
|
34,780 |
|
|
|
|
|
97,046 |
|
68,615 |
|
|
|
|
|
150,130 |
|
120,786 |
|
|
|
|
|
|
|
|
Equity and liabilities |
|
Note |
|
Dec 31, 2020 |
|
June 30, 2021 |
Equity |
|
|
|
|
|
|
Issued capital |
|
9 |
|
2,654 |
|
|
2,693 |
|
Capital reserve |
|
9 |
|
125,916 |
|
|
130,153 |
|
Retained earnings and other reserves |
|
|
|
(62,888 |
) |
|
(75,913 |
) |
Non‑controlling interests |
|
|
|
95 |
|
|
141 |
|
|
|
|
|
65,777 |
|
|
57,074 |
|
Non‑current
liabilities |
|
|
|
|
|
|
Non‑current loans |
|
10.1 |
|
401 |
|
|
200 |
|
Lease liabilities |
|
10.1 |
|
17,677 |
|
|
16,209 |
|
Deferred tax liabilities |
|
|
|
207 |
|
|
246 |
|
Government grants |
|
10.2 |
|
8,950 |
|
|
8,640 |
|
|
|
|
|
27,235 |
|
|
25,295 |
|
Current
liabilities |
|
|
|
|
|
|
Government grants |
|
10.2 |
|
1,342 |
|
|
1,352 |
|
Current loans |
|
10.1 |
|
2,492 |
|
|
3,883 |
|
Lease liabilities |
|
10.1 |
|
3,528 |
|
|
3,299 |
|
Trade payables |
|
10.2 |
|
31,736 |
|
|
14,014 |
|
Liabilities from income taxes |
|
10.2 |
|
58 |
|
|
143 |
|
Other liabilities |
|
10.2 |
|
17,962 |
|
|
15,726 |
|
|
|
|
|
57,118 |
|
|
38,417 |
|
|
|
|
|
150,130 |
|
|
120,786 |
|
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 six months ended June 30, 2020, and
2021(in EUR k)
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30 |
|
|
Note |
|
2020 |
|
|
2021 |
|
Operating
activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
|
|
(18,967 |
) |
|
(12,785 |
) |
|
|
|
|
|
|
|
Adjustments to
reconcile loss to cash flow from operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization and depreciation |
|
5 |
|
4,432 |
|
|
6,670 |
|
Interest income |
|
|
|
(13 |
) |
|
— |
|
Interest expense |
|
|
|
718 |
|
|
471 |
|
Expected credit loss allowances on trade receivables and contract
assets |
|
7 |
|
1,674 |
|
|
675 |
|
Share‑based payment expenses |
|
11 |
|
1,393 |
|
|
4,276 |
|
Tax expense |
|
|
|
129 |
|
|
124 |
|
Other non‑cash items |
|
|
|
(686 |
) |
|
126 |
|
|
|
|
|
|
|
|
Changes in operating
assets and liabilities |
|
|
|
|
|
|
Inventories |
|
|
|
(6,252 |
) |
|
2,124 |
|
Trade receivables and contract assets |
|
7 |
|
(64 |
) |
|
10,034 |
|
Other assets |
|
7 |
|
269 |
|
|
328 |
|
Trade payables |
|
10.2 |
|
274 |
|
|
(17,722 |
) |
Other liabilities |
|
10.2 |
|
2,457 |
|
|
(2,151 |
) |
|
|
|
|
|
|
|
Cash flow used in
operating activities |
|
|
|
(14,636 |
) |
|
(7,830 |
) |
|
|
|
|
|
|
|
Investing
activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for investments in
intangible assets |
|
5 |
|
(3,965 |
) |
|
(2,089 |
) |
Cash paid for investments in
property, plant and equipment |
|
|
|
(3,072 |
) |
|
(2,696 |
) |
Grants received for investment
in property, plant and equipment |
|
10.2 |
|
390 |
|
|
— |
|
Interest received |
|
|
|
13 |
|
|
— |
|
|
|
|
|
|
|
|
Cash flow used in
investing activities |
|
|
|
(6,634 |
) |
|
(4,785 |
) |
|
|
|
|
|
|
|
Financing
activities |
|
|
|
|
|
|
Cash paid for acquisition of
non-wholly owned subsidiary |
|
|
|
(75 |
) |
|
— |
|
Cash received from loans |
|
10.1 |
|
928 |
|
|
1,769 |
|
Cash repayments of loans |
|
10.1 |
|
(1,260 |
) |
|
(185 |
) |
Cash repayments of lease
liabilities |
|
10.1 |
|
(1,619 |
) |
|
(2,263 |
) |
Interest paid |
|
|
|
(399 |
) |
|
(82 |
) |
|
|
|
|
|
|
|
Cash flow from used in
financing activities |
|
|
|
(2,425 |
) |
|
(761 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in cash and cash
equivalents |
|
|
|
(23,695 |
) |
|
(13,376 |
) |
Cash and cash equivalents at
the beginning of the period |
|
|
|
41,095 |
|
|
48,156 |
|
Cash and cash equivalents at
the end of the period |
|
|
|
17,400 |
|
|
34,780 |
|
The accompanying notes form an integral part of these unaudited
interim condensed consolidated financial statements.
CENTOGENE
Lennart Streibel
Investor Relations
investor.relations@centogene.com
FTI Consulting
Robert Stanislaro
robert.stanislaro@fticonsulting.com
Rachel Kleiman
rachel.kleiman@fticonsulting.com
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