Centogene N.V. (Nasdaq: CNTG), the
commercial-stage essential biodata life science partner for rare
and neurodegenerative diseases, today announced financial results
for the first quarter ending March 31, 2022, reaffirmed guidance,
and provided a business update.
“We are on track with our renewed focus on the Core Business.
The Diagnostics segment continued to show double digit growth rates
year-over-year and is planned to grow faster than the market. We
are on target to enhance our Pharma offering – broadening our
commercial team, marketing a differentiated product portfolio, and
growing the pipeline to return the Pharma segment to steady growth
in 2022. We see the extension of the market access partnership with
Takeda and the new contract with Agios as important proof points of
our biopharma strategy,” stated Kim Stratton, Chief Executive
Officer at CENTOGENE. “In the first quarter, we phased out the
COVID-19 Testing Business as planned, allowing our organization to
pivot and be focused on Core Business execution."
First Quarter 2022 Financial
Highlights
- Overall revenues of €10.3 million
(excluding the discontinued operation) were recorded in Q1 2022, a
3% increase compared to €10.0 million in Q1 2021
- Diagnostics segment revenues of €7.1
million in Q1 2022, an increase of 11% compared to €6.4 million in
Q1 2021, reflecting the fourth consecutive quarter of
year-over-year revenues growth in the segment. The increase in
revenues was primarily related to an increase in revenues from
Whole Exome Sequencing (WES) and Whole Genome Sequencing (WGS) of
18%
- Pharma segment revenues of €3.2
million in Q1 2022, a decrease of 10% compared to €3.6 million in
Q1 2021
- The COVID-19 Testing Business was
phased out in Q1 2022 and reported as discontinued operations but
no longer as a segment. Revenues from the COVID-19 Business were
€19.5 million in Q1 2022, compared to €55.0 million in Q1 2021.
Discontinued operations in the period contributed positively to net
income and cash flow
- Net loss of €6.4 million in Q1 2022,
compared to net loss of €4.8 million in Q1 2021
- Total segment adjusted EBITDA of
€1.9 million for the two continuing segments was recorded in Q1
2022, compared to €2.6 million in Q1 2021. This mainly reflects the
lower proportion of revenues in the higher margin Pharma
segment
- Adjusted EBITDA from COVID-19
business for the three months ended March 31, 2022 was €6,106
thousand as compared to €10,167 thousand for the three months ended
March 31, 2021. The decrease was driven by the reduction in
COVID-19 test order intakes as the business was phased out
- Cash and cash equivalents were €42.7
million as of March 31, 2022, compared to €17.8 million for the
period ending December 31, 2021. The reported cash position per end
of Q1 2022 reflects proceeds from the debt (first tranche) and
equity financings completed in February 2022
“With the completion of the financings earlier this year,
CENTOGENE is operating from a stable financial position. We rolled
out multiple initiatives to extend our cash runway by closely
managing margins and corporate expenses. As a result, we are
expecting to show improvements in our 2022 adj. EBITDA versus the
prior year,” added Miguel Coego, Chief Financial Officer of
CENTOGENE.
Recent Business Highlights
Corporate
- Appointed executive and Supervisory
Board leadership, including Kim Stratton as CEO, Miguel Coego as
CFO, and Dr. Andreas Busch as Vice Chairman of the Supervisory
Board
- Closed $62 million aggregate equity
and debt financings to support growth plan, including a €15 million
(approx. $17 million) private placement incl. 1.3 million warrants
at an exercise price of $7.72 per share from leading growth
investors and a $45 million senior secured loan from Oxford Finance
in Q1 2022, with the second tranche of the loan subject to
operating covenants
- Added ~28,000 individuals to the
CENTOGENE Biodatabank in Q1 2022; CENTOGENE believes its
Biodatabank is the world’s largest real-world data repository for
rare and neurodegenerative diseases, which includes samples as well
as data and cell lines from patients from over 120 countries
- Authored 15 peer-reviewed scientific
publications in Q1 2022, focused on generating critical insights
into an array of diseases, including rare genetic and neurological
diseases, e.g., the prevalence of Fabry disease among patients with
Parkinson's disease
- Phased out the COVID-19 testing
services end of Q1 2022 according to plan
Pharma
- Expanded partnership with Agios
Pharmaceuticals for clinical development of PYRUKYND® (mitapivat)
to treat children with rare blood disease
- Extended market access partnership
with Takeda to accelerate path from diagnosis to available
treatments for rare metabolic and rare neurodegenerative
diseases
- Expanded Data Access and
Collaboration R&D Agreement with Pfizer to advance discovery
and validation of novel genetic targets as candidates for the
development of new therapies for rare diseases
- Initiated collaboration with
Insilico Medicine for Niemann-Pick disease Type C (NPC) target
discovery, leveraging the CENTOGENE Biodatabank
- Currently leading three
observational studies for patient finding and market access in
collaboration with our pharma partners in rare and
neurodegenerative disorders
Diagnostics
- Reported order intake of
approximately 16,300 test requests in our diagnostics segment,
representing an increase of approximately 24% as compared to
approximately 13,100 test requests in the same period in 2021
- Launch of CENTOGENE MOx – a
portfolio of single-step multiomic solutions that combines
sequencing and biochemical testing to enable early diagnosis,
improved prognosis, and precision medicine
- Global release of CentoCloud, a
cloud-based, clinical decision support platform enabling
decentralized analysis, interpretation, and quality reporting for
laboratories around the world
- Received CE-mark for CentoCloud,
making it one of the only decentralized SaaS and clinical decision
support platforms compliant with European IVD regulatory
framework
- Major Next Generation Sequencing
(NGS) panel update with more than 3,000 genes revised and 1,864
genes added to maximize the clinical utility for rare metabolic and
neurodegenerative diseases
- Contributed to Europe-wide efforts
to update guidelines for WGS in rare disease diagnostics
2022 Financial Guidance
The Company has reaffirmed its previously communicated 2022
annual revenue guidance for year-over-year revenue growth of 15% to
20%. As a result, CENTOGENE expects revenues to be in the range of
€50 million to €52 million. This reflects the classification of the
COVID-19 Testing Business as discontinued operations.
About CENTOGENE CENTOGENE
(Nasdaq: CNTG) is transforming real-world clinical, genetic, and
multiomic data to enable better health outcomes for patients with
rare and neurodegenerative diseases. For over 15 years, CENTOGENE
has been providing diagnostic insights to patients with genetic
diseases through our network of nearly 30,000 active physicians.
CENTOGENE now believes its Biodatabank is the world’s largest
real-world data repository of corresponding patients from more than
120 countries. Simplified logistics solutions, including CentoCard®
for sending biosamples, and our ISO, CAP, & CLIA certified
state-of-the-art multiomic reference labs offer patients rapid and
reliable diagnoses to support the identification and
personalization of their treatments. Ultimately, offering the best
treatment for patients involves developing new or better therapies.
We are de-risking orphan drug discovery and development by
partnering with more than 30 biopharma in target & drug
screening, clinical development, market access and expansion.
CENTOGENE engages in biodata partnerships with our Biodata Licenses
and Insight Reports.
To discover more about our products, pipeline, and
patient-driven purpose, visit www.centogene.com and follow us
on LinkedIn.
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 31, 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.
Centogene N.V.Unaudited
interim condensed consolidated statements of comprehensive
loss for the three months ended March 31, 2022 and
2021(in EUR k)
|
|
|
|
|
|
|
|
|
|
|
For the three months ended March 31 |
|
|
Note |
|
2022 |
|
2021* |
Revenue |
|
4, 5 |
|
10,327 |
|
|
9,981 |
|
Cost of sales |
|
|
|
6,450 |
|
|
6,208 |
|
Gross
profit |
|
|
|
3,877 |
|
|
3,773 |
|
Research and development
expenses |
|
|
|
4,614 |
|
|
4,335 |
|
General administrative
expenses |
|
|
|
7,906 |
|
|
11,596 |
|
Selling expenses |
|
|
|
2,394 |
|
|
1,949 |
|
Impairment of financial
assets |
|
8 |
|
154 |
|
|
95 |
|
Other operating income |
|
6.1 |
|
733 |
|
|
366 |
|
Other operating expenses |
|
6.2 |
|
1 |
|
|
34 |
|
Operating
loss |
|
|
|
(10,459 |
) |
|
(13,870 |
) |
Changes in fair value of
warrants |
|
11.2 |
|
238 |
|
|
— |
|
Interest and similar income |
|
|
|
1 |
|
|
— |
|
Interest and similar expense |
|
|
|
859 |
|
|
259 |
|
Financial costs, net |
|
|
|
(620 |
) |
|
(259 |
) |
Loss before taxes from
continuing operations |
|
|
|
(11,079 |
) |
|
(14,129 |
) |
Income tax expenses |
|
|
|
4 |
|
|
— |
|
Loss for the period from
continuing operations |
|
|
|
(11,083 |
) |
|
(14,129 |
) |
Net income from
discontinued operations, net of tax |
|
7 |
|
4,601 |
|
|
9,240 |
|
Loss for the
period |
|
|
|
(6,482 |
) |
|
(4,889 |
) |
Other comprehensive income, all
attributable to equity holders of the parent |
|
|
|
94 |
|
|
121 |
|
Total comprehensive
loss |
|
|
|
(6,388 |
) |
|
(4,768 |
) |
Attributable to: |
|
|
|
|
|
|
Equity holders of the parent |
|
|
|
(6,415 |
) |
|
(4,803 |
) |
Non‑controlling interests from
continuing operations |
|
|
|
— |
|
|
— |
|
Non‑controlling interests from
discontinued operations |
|
|
|
27 |
|
|
35 |
|
|
|
|
|
(6,388 |
) |
|
(4,768 |
) |
Net loss per share -
Basic and diluted from (in EUR) |
|
|
|
|
|
|
Continuing operations |
|
|
|
(0.48 |
) |
|
(0.63 |
) |
Loss attributable to parent |
|
|
|
(0.28 |
) |
|
(0.22 |
) |
|
|
|
|
|
|
|
*The comparative numbers have been re-presented as a result of
the discontinued operations. Refer to Note 7- Discontinued
Operations.
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 of March 31, 2022 and December 31,
2021(in EUR k)
|
|
|
|
|
|
|
Assets |
|
Note |
|
Mar 31, 2022 |
|
Dec 31, 2021 |
|
|
|
|
|
|
Revised |
Non‑current
assets |
|
|
|
|
|
|
Intangible assets |
|
|
|
8,183 |
|
9,194 |
Property, plant and equipment* |
|
2.2 |
|
7,674 |
|
9,464 |
Right-of-use assets |
|
|
|
17,972 |
|
18,904 |
Other assets |
|
8 |
|
2,972 |
|
2,972 |
|
|
|
|
36,801 |
|
40,534 |
Current
assets |
|
|
|
|
|
|
Inventories |
|
|
|
2,067 |
|
3,869 |
Trade receivables and contract assets |
|
8 |
|
21,125 |
|
24,337 |
Other assets |
|
8 |
|
5,443 |
|
5,453 |
Cash and cash equivalents |
|
9 |
|
42,666 |
|
17,818 |
|
|
|
|
71,301 |
|
51,477 |
|
|
|
|
108,102 |
|
92,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity and liabilities |
|
Note |
|
Mar 31, 2022 |
|
Dec 31, 2021 |
|
|
|
|
|
|
Revised |
Equity |
|
|
|
|
|
|
Issued capital |
|
10 |
|
3,250 |
|
|
2,708 |
|
Capital reserve |
|
10 |
|
143,456 |
|
|
133,897 |
|
Retained earnings and other reserves |
|
|
|
(114,120 |
) |
|
(107,705 |
) |
Non‑controlling interests |
|
|
|
220 |
|
|
193 |
|
|
|
|
|
32,806 |
|
|
29,093 |
|
Non‑current
liabilities |
|
|
|
|
|
|
Non‑current loans |
|
11,1 |
|
21,890 |
|
|
— |
|
Lease liabilities* |
|
11,1 |
|
14,540 |
|
|
15,394 |
|
Deferred tax liabilities |
|
|
|
59 |
|
|
79 |
|
Government grants |
|
11,2 |
|
7,506 |
|
|
8,028 |
|
Warrants liability |
|
11,2 |
|
2,603 |
|
|
— |
|
|
|
|
|
46,598 |
|
|
23,501 |
|
Current
liabilities |
|
|
|
|
|
|
Government grants |
|
11,2 |
|
1,517 |
|
|
1,368 |
|
Current loans |
|
11,1 |
|
3,574 |
|
|
3,815 |
|
Lease liabilities* |
|
2.2, 11.1 |
|
2,953 |
|
|
3,330 |
|
Trade payables |
|
11,2 |
|
5,897 |
|
|
11,252 |
|
Liabilities from income taxes |
|
11,2 |
|
198 |
|
|
178 |
|
Other liabilities |
|
11,2 |
|
14,559 |
|
|
19,474 |
|
|
|
|
|
28,698 |
|
|
39,417 |
|
|
|
|
|
108,102 |
|
|
92,011 |
|
|
|
|
|
|
|
|
|
|
*Property, plant and equipment and lease liabilities as of
December 31, 2021 have been revised. Refer to Note 2.2 – Revision
of selected assets and liabilities in the consolidated statement of
financial position and selected income and expenses in the
consolidated statement of comprehensive loss.
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 three months ended March 31, 2022 and
2021(in EUR k)
|
|
|
|
|
|
|
|
|
|
|
For the three months ended March 31 |
|
|
Note |
|
2022 |
|
2021* |
Operating
activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes from continuing operations |
|
|
|
(11,079 |
) |
|
(14,129 |
) |
Income before taxes from
discontinued operations |
|
7 |
|
4,614 |
|
|
9,240 |
|
Loss before taxes |
|
|
|
(6,465 |
) |
|
(4,889 |
) |
|
|
|
|
|
|
|
Adjustments to
reconcile loss to cash flow from operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization and depreciation |
|
5 |
|
3,808 |
|
|
3,286 |
|
Interest expense |
|
|
|
859 |
|
|
259 |
|
Expected credit loss allowances on trade receivables and contract
assets |
|
8 |
|
146 |
|
|
95 |
|
Gain on disposal of property, plant and equipment |
|
|
|
(527 |
) |
|
— |
|
Share‑based payment (true up)/ expenses |
|
12 |
|
(1,957 |
) |
|
2,042 |
|
Fair value adjustments of warrants |
|
|
|
(238 |
) |
|
— |
|
Other non‑cash items |
|
|
|
(141 |
) |
|
(184 |
) |
|
|
|
|
|
|
|
Changes in operating
assets and liabilities |
|
|
|
|
|
|
Inventories |
|
|
|
1,802 |
|
|
2,083 |
|
Trade receivables and contract assets |
|
8 |
|
3,066 |
|
|
500 |
|
Other assets |
|
8 |
|
10 |
|
|
(941 |
) |
Trade payables |
|
11.2 |
|
(5,355 |
) |
|
(6,638 |
) |
Other liabilities |
|
11.2 |
|
(4,908 |
) |
|
4,629 |
|
|
|
|
|
|
|
|
Thereof cash flow used in
continuing operating activities |
|
|
|
(12,735 |
) |
|
(8,720 |
) |
Thereof cash flow from
discontinued operating activities |
|
7 |
|
2,835 |
|
|
8,962 |
|
Net cash flow (used
in)/ from operating activities |
|
|
|
(9,900 |
) |
|
242 |
|
|
|
|
|
|
|
|
Investing
activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for investments in
intangible assets |
|
5 |
|
(44 |
) |
|
(1,326 |
) |
Cash paid for investments in
property, plant and equipment |
|
|
|
(79 |
) |
|
(1,970 |
) |
Cash received for disposal of
property, plant and equipment |
|
|
|
575 |
|
|
— |
|
|
|
|
|
|
|
|
Thereof cash flow from
continuing investing activities |
|
|
|
(123 |
) |
|
(1,526 |
) |
Thereof cash flow from
discontinued investing activities |
|
7 |
|
575 |
|
|
(1,770 |
) |
Cash flow from/ (used
in) investing activities |
|
|
|
452 |
|
|
(3,296 |
) |
|
|
|
|
|
|
|
Financing
activities |
|
|
|
|
|
|
Cash received from issuance of
shares |
|
10 |
|
12,058 |
|
|
— |
|
Cash received from issuance of
warrants |
|
|
|
2,833 |
|
|
— |
|
Cash received from loans |
|
11.1 |
|
21,695 |
|
|
1,587 |
|
Cash repayments of loans |
|
11.1 |
|
(200 |
) |
|
(185 |
) |
Cash repayments of lease
liabilities |
|
11.1 |
|
(1,231 |
) |
|
(1,222 |
) |
Interest paid |
|
|
|
(859 |
) |
|
(61 |
) |
|
|
|
|
|
|
|
Thereof net cash flow from
continuing financing activities |
|
|
|
34,705 |
|
|
394 |
|
Thereof net cash flow used in
discontinued financing activities |
|
|
|
(409 |
) |
|
(275 |
) |
Net cash flow from
financing activities |
|
|
|
34,296 |
|
|
119 |
|
|
|
|
|
|
|
|
Changes in cash and cash
equivalents |
|
|
|
24,848 |
|
|
(2,935 |
) |
Cash and cash equivalents at
the beginning of the period |
|
|
|
17,818 |
|
|
48,156 |
|
Cash and cash equivalents at
the end of the period |
|
|
|
42,666 |
|
|
45,221 |
|
|
|
|
|
|
|
|
|
|
*The comparative numbers have been re-presented as a result of
the discontinued operations. Refer to Note 7- Discontinued
Operations.
The accompanying notes form an integral part of these unaudited
interim condensed consolidated financial statements.
Reconciliation of segment Adjusted EBITDA to Group loss
before taxes from continuing operations
|
|
|
|
|
For the three months ended March 31 |
|
2022 |
|
2021 |
Reported segment Adjusted EBITDA |
|
1,911 |
|
|
2,551 |
|
Corporate expenses |
|
(11,964 |
) |
|
(12,020 |
) |
|
|
(10,053 |
) |
|
(9,469 |
) |
Share-based payment (true-up)/ expenses (Note 12) |
|
1,957 |
|
|
(2,042 |
) |
Depreciation and amortization |
|
(2,363 |
) |
|
(2,359 |
) |
Operating loss from continuing operations |
|
(10,459 |
) |
|
(13,870 |
) |
Financial costs, net |
|
(620 |
) |
|
(259 |
) |
Loss before taxes from continuing operations for the three
months ended March 31 |
|
(11,079 |
) |
|
(14,129 |
) |
|
|
|
|
|
|
|
Media Contact:CENTOGENELennart
StreibelInvestor RelationsInvestor.Relations@centogene.com
Ben LeggCorporate CommunicationsPress@centogene.com
Stern IRSuzanne Messere+1 (212)
698-8801suzanne.messere@sternir.com
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