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
fourth quarter and fiscal year ended December 31, 2021, and
provided a business update.
“2021 was a transformative year, during which we further
reinforced our position as the partner of choice for partners
seeking innovative, new approaches to diagnose and treat rare and
neurodegenerative diseases,” stated Kim Stratton, Chief Executive
Officer at CENTOGENE. “In the fourth quarter of 2021, we recorded
solid quarter-over-quarter revenue growth in our core business
diagnostics and pharma. We are well positioned and anticipate
continued strengthening of our core business through 2022, as we
specifically focus on biopharma to deliver on existing
partnerships, while also expanding and converting our pipeline of
partnership opportunities. Our commitment to maintaining our
position as the partner with the most comprehensive clinically
relevant data set available for research and development purposes
in rare and neurodegenerative diseases remains resolute.”
Fourth Quarter 2021 Financial
Highlights
- Overall revenues of €42.9 million
were recorded in Q4 2021, a 39% decrease compared to €70.3 million
in Q4 2020, driven primarily by the anticipated decrease of the
COVID-19 testing business, partially offset by growth in the
Company’s Pharma and Diagnostics segments (“Core Business”). As
expected, revenues from the COVID-19 segment decreased from €59.8
million in Q4 2020 to €28.9 million in Q4 2021 as the Company is
preparing to exit this business
- Revenues from the Core Business
increased by 34%, driven by revenues from the Diagnostics segment
of €7.5 million in Q4 2021, an increase of 30% compared to €5.8
million in Q4 2020, and revenues from the Pharma segment of €6.5
million in Q4 2021, an increase of 39% versus €4.7 million in Q4
2020.
- Net loss of €12.3 million in Q4
2021, compared to net profit of €3.4 million in Q4 2020
- Total segment adjusted EBITDA of
€11.9 million was recorded in Q4 2021 compared to €28.2 million in
Q4 2020. This mainly reflects the adjusted EBITDA contribution from
COVID-19 testing having decreased by €16.5 million year-over-year,
partially offset by a stronger adjusted EBITDA contribution from
the Pharma and Diagnostics segments
Full Year 2021 Financial Highlights
- Overall revenues of €189.9 million
were recorded in FY 2021, a 48% increase compared to €128.4 million
in FY 2020. This was driven by higher revenues from the COVID-19
testing business in FY 2021 as well as year over year revenue
growth in the Core Business
- Revenues from Core Business were
€43.5 million in FY 2021, an increase of 11% compared to €39.1
million in FY 2020, driven mainly by Diagnostics segment growth of
26%
- Revenues from COVID-19 testing were
€146.4 million in FY 2021, an increase of 64% from €89.3 million in
FY 2020
- The gross profit margin was 15% in
FY 2021, compared to 35% in FY 2020. The decrease was driven by the
margin development in the COVID-19 testing business. This was
partially offset by a 20% gross margin improvement in the Core
Business
- The net loss was €46.9 million in FY
2021, compared to a net loss of €21.4 million in FY 2020
- The total segment adjusted EBITDA
was €29.5 million in FY 2021 compared to €41.0 million in FY 2020
from the Company’s Pharma, Diagnostics, and COVID-19 testing
segments. This mainly reflected the adjusted EBITDA contribution
from COVID-19 testing having decreased by €16.5 million
year-over-year which was partially offset by a stronger adjusted
EBITDA contribution from the Diagnostics segment
- Cash and cash equivalents were €17.8
million as of December 31, 2021, compared to €48.2 million for the
period ending December 31, 2020. The reported cash position per
year-end 2021 does not reflect proceeds from the debt and equity
financing completed in February 2022
“We are pleased to have exceeded the revenue guidance we
forecasted for the year 2021. With the completion of the financing
earlier this year, CENTOGENE is operating from a stable financial
position, allowing us to deliver on our strategic initiatives,
while ensuring efficiency and prudence in our operational
execution,” added Miguel Coego, EVP Finance & Legal and Interim
Chief Financial Officer of CENTOGENE.
Recent Business Highlights
Corporate
- Closed $62 Million aggregate equity
and debt financings to support growth plan, including €15 million
(approx. $17 million) private placement from leading growth
investors and a $45 million senior secured loan from Oxford
Finance
- Appointed new executive and
Supervisory Board leadership, including Kim Stratton as CEO and Dr.
Andreas Busch as Vice Chairman of the Supervisory Board
- Added approximately 24,000
individuals to CENTOGENE’s rare disease-centric Bio/Databank in Q4
2021, bringing the total number of individuals added in FY 2021 to
94,000. This Bio/Databank is a one-of-a-kind real-world data
repository which includes samples as well as data and cell lines
for rare, metabolic, and neurodegenerative diseases from patients
from over 120 countries
- Authored 10 peer-reviewed scientific
publications in Q4 2021, focused on generating critical insights
into an array of diseases, including Parkinson’s disease
Pharma
- Continued partnership with Pfizer
under Data Access and Collaboration R&D Agreement to
advance the discovery and validation of novel genetic targets as
candidates for the development of new therapies for rare
diseases
- Enrolled first patients in an
ongoing clinical study partnered with Alector, Inc. targeting
data-rich genetic testing for more than 3,000 frontotemporal
dementia (FTD) patients
- Expanded the clinical development
partnership with Agios Pharmaceuticals to provide genomics and
centralized lab support for Agios’ three global, pivotal trials in
thalassemia and sickle cell disease
- Joined forces with Insilico Medicine
for Niemann-Pick Disease Type C (NPC) target discovery, leveraging
CENTOGENE’s Bio/Databank and Artificial Intelligence (AI) to
accelerate orphan drug development
- Received a digital healthcare
innovation award for the Company’s Artificial Intelligence (AI)
platform for biomarker discovery
- Currently leading 10 observational
longitudinal clinical studies to validate/monitor biomarkers. The
pilot study HPP Genetics and HAEKA project have been completed and
reported to our pharma partners
Diagnostics
- Released CentoCloud, a cloud-based,
global bioinformatics solution enabling decentralized analysis,
interpretation, and quality reporting for laboratories around the
world
- Signed a collaboration with TWIST
Bioscience on the development and commercialization of custom assay
kits for rare diseases
- Reported order intake of 15,300 test
requests in Q4 2021, which represents a 30% increase compared to
11,750 in the same period in 2020.
COVID-19 Testing
- Processed 456,100 test requests for
SARS-CoV-2 testing in Q4 2021
- Initiated the phase out of the
COVID-19 testing services by the end of Q1 2022.
2022 Financial Guidance
The Company has issued 2022 annual guidance and expects total
revenues to be in the range of €68 million to €70 million. The
portion of total revenues derived from COVID-19 testing is expected
to be approximately €18 million with expected phaseout at the end
of Q1 2022. The Company expects year-over-year growth in Core
Business revenues (i.e., revenues derived from the Pharma and
Diagnostics segments) to be between 15% to 20%.
Conference Call Information
Management will host a conference call at 2 p.m. CET/8 a.m. ET
on March 30, 2022, to discuss financial results and recent
developments. To access the conference call and webcast, please
register at:
http://emea.directeventreg.com/registration/5737758
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 will also be available on the
Investor Relations page of the Company’s website at
http://investors.centogene.com.
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 650,000 individuals 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, 2021, 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 economic and geopolitical conditions and 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, our ability
to streamline cash usage, our requirement for additional financing,
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 March 30, 2022,
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.
Media Contact:CENTOGENELennart
StreibelInvestor RelationsInvestor.Relations@centogene.com
Ben LeggCorporate
CommunicationsPress@centogene.com Stern
IRBrendan Payne+1 (212) 698
8695brendan.payne@sternir.com
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