UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: February 21, 2024
(Commission File No. 001-39308)
CALLIDITAS THERAPEUTICS AB
(Translation of registrant’s name into
English)
Kungsbron 1, D5
SE-111 22
Stockholm, Sweden
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F x
Form 40-F ¨
Company Announcement and Year-End Report
On February 21, 2024, the Company announced its unaudited results for
the year ended December 31, 2023, which are further described in the Company’s Year-End Report January 1 – December 31, 2023,
copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated by reference herein.
The information contained in this Form 6-K, including Exhibits 99.1
and 99.2, is hereby incorporated by reference into the registrant’s Registration Statements on Form F-3 (File No. 333-265881) and
Form S-8 (File Nos. 333-240126 and 333-272594).
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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CALLIDITAS THERAPEUTICS AB |
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Date: February 21, 2024 |
By: |
/s/ Fredrik Johansson |
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Fredrik Johansson
Chief Financial Officer |
Exhibit 99.1
Stockholm, Sweden | | February 21, 2024 |
Calliditas Year-end report, January – December 2023
Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX)
2023: Full approval for TARPEYO in the US; a year of successes
OCTOBER – DECEMBER 2023
(COMPARED TO OCTOBER – DECEMBER 2022)
| ● | Net sales amounted to SEK 451.6 million, of which TARPEYO® net sales
amounted to SEK 347.3 million, for the three months ended
December 31, 2023. For the three months ended December 31, 2022, net sales amounted to SEK 429.0 million, of which TARPEYO
net sales amounted to SEK 167.3 million. |
| ● | Operating income amounted to SEK 41.8 million
and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively. |
| ● | Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07
for the three months ended December 31, 2023, and 2022, respectively. |
| ● | Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31,
2023, and 2022, respectively. |
JANUARY – DECEMBER 2023
(COMPARED TO JANUARY –DECEMBER 2022)
| ● | Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted
to SEK 1,075.8 million, for the year ended December 31, 2023. For the year ended December 31, 2022, net sales amounted to SEK
802.9 million, of which TARPEYO net sales amounted to SEK 372.2 million. |
| ● | Operating loss amounted to SEK 373.1 million and SEK 421.9 million for the
year ended December 31, 2023, and 2022, respectively. |
| ● | Loss per share before and after dilution amounted to SEK 8.69 and SEK 7.78
for the year ended December 31, 2023, and 2022, respectively. |
| ● | For the year ended December 31, 2023, no dividend is proposed. |
“In December we were granted full approval by the FDA
for TARPEYO – a crowning achievement after many years of striving to bring an approved disease modifying treatment to patients with
primary IgAN.”
CEO Renée Aguiar-Lucander
KEY TAKEAWAYS FROM Q4, 2023
| ● | In November, Calliditas’ partner Everest Medicines announced that China’s
National Medical Products Administration (NMPA) had approved Nefecon for the treatment
of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. |
| ● | In November, Calliditas announced the initiation of a Phase 2 clinical study
to evaluate setanaxib in Alport syndrome. |
| ● | In December, Calliditas received approval (Notice of Allowance) regarding
a US patent application for TARPEYO®. In the first quarter of 2024, notice was issued regarding the patent, which provides patent
in the US through 2043. |
| ● | In December, the United States (US) Food and Drug Administration
(FDA) granted Calliditas full approval of TARPEYO® for reduction of kidney loss in adult IgAN patients at risk of disease progression. |
EXPECTED KEY EVENTS UPCOMING 6 MONTHS
| ● | Read out of the Nefecon Open label Phase 3 extension trial, which will provide
data on retreatment with Nefecon. |
| ● | The transfer of the Marketing Authorization Holder (MAH) approval to Everest
Medicines and commercial launch of Nefecon in China. |
| ● | European Commission decision regarding a potential full approval for Kinpeygo
for Calliditas’ partner STADA. |
| ● | Full data read out of the setanaxib Phase 2 trial in head
and neck cancer. |
OUTLOOK FOR 2024
Calliditas expects continued revenue growth:
Total net sales are estimated to be USD 150-180 million for the year
ending December 31, 2024
INVESTOR PRESENTATION
February 21, 2024, 14:30 CET
Link to webcast: https://ir.financialhearings.com/calliditas-therapeutics-q4-report-2023
To participate via conference call register via this link: https://conference.financialhearings.com/teleconference/?id=50046870
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
The information in the press release is information
that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through
the agency of the contact person set out above, on February 21, 2024, at 07:00 a.m. CET.
About Calliditas
Calliditas Therapeutics is a biopharma company headquartered in Stockholm,
Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical
needs. Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on
the Nasdaq Global Select Market (ticker: CALT). Visit Calliditas.com for further information.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the
development of Calliditas’ pipeline. The words “may,” “will,” “could,”
“would,” “should,” “expect,” “plan,” “anticipate,” “intend,”
“believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “target,” and similar expressions are intended to identify forward-looking statements, although
not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based
on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors
that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements
contained in this press release, including, without limitation, any related to Calliditas’ business, operations, clinical
trials, intellectual property of the NEFECON franchise globally, competition from other companies, pipeline development, revenue and
product sales projections or forecasts, 2024 revenue guidance and other risks identified in the section entitled “Risk
Factors” in Calliditas’ reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place
undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation
to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on
which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in
the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas’ views
only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Exhibit 99.2
| YEAR-END REPORT
JANUARY – DECEMBER
2023
Q4 |
| Calliditas Therapeutics | Year-End Report 2023: January – December 2
347 108% 974
Key takeaways from Q4, 2023
Outlook 2024
OCTOBER – DECEMBER 2023
(COMPARED TO OCTOBER – DECEMBER 2022)
JANUARY – DECEMBER 2023
(COMPARED TO JANUARY –DECEMBER 2022)
“In December we were granted full OCT – DEC 2023
approval by the FDA for TARPEYO
– a crowning achievement after many
years of striving to bring an approved
disease modifying treatment to patients
with primary IgAN.”
OCT – DEC 2023 DEC 31, 2023
MSEK
TARPEYO net sales
Renée Aguiar-Lucander / CEO
TARPEYO net sales
growth in SEK (vs Q4
2022)
MSEK
Cash position
Year-end report
January – December 2023
• Net sales amounted to SEK 451.6 million, of which
TARPEYO® net sales amounted to SEK 347.3 million, for
the three months ended December 31, 2023. For the three
months ended December 31, 2022 net sales amounted to
SEK 429.0 million, of which TARPEYO net sales amounted
to SEK 167.3 million.
• Operating income amounted to SEK 41.8 million and SEK
32.5 million for the three months ended December 31,
2023 and 2022, respectively.
• Loss per share before and after dilution amounted to SEK
0.34 and SEK 0.07 for the three months ended December
31, 2023 and 2022, respectively.
• Cash amounted to SEK 973.7 million and SEK 1,249.1
million as of December 31, 2023 and 2022, respectively.
• In November, Calliditas’ partner Everest Medicines an-nounced that China’s National Medical Products Adminis-tration (NMPA) had approved Nefecon for the treatment of
primary immunoglobulin A nephropathy (IgAN) in adults at
risk of disease progression.
• In November, Calliditas announced the initiation of a Phase
2 clinical study to evaluate setanaxib in Alport syndrome.
• In December, Calliditas received approval (Notice of Allow-ance) regarding a US patent application for TARPEYO®. In
the first quarter of 2024, notice was issued regarding the
patent, which provides patent in the US through 2043.
• In December, the United States (US) Food and Drug Admin-istration (FDA) granted Calliditas full approval of TARPEYO®
for reduction of kidney loss in adult IgAN patients at risk of
disease progression.
• Read out of the Nefecon Open label Phase 3 extension
trial, which will provide data on retreatment with Nefecon.
• The transfer of the Marketing Authorization Holder (MAH)
approval to Everest Medicines and commercial launch of
Nefecon in China.
• European Commission decision regarding a potential full
approval for Kinpeygo for Calliditas’ partner STADA.
• Full data read out of the setanaxib Phase 2 trial in head
and neck cancer.
• For 2024, Calliditas expects continued revenue growth:
Total net sales are estimated to be USD 150-180 million for the year ending December 31, 2024
• Net sales amounted to SEK 1,206.9 million, of which
TARPEYO net sales amounted to SEK 1,075.8 million, for
the year ended December 31, 2023. For the year ended
December 31, 2022 net sales amounted to SEK 802.9
million, of which TARPEYO net sales amounted to SEK
372.2 million.
• Operating loss amounted to SEK 373.1 million and SEK
421.9 million for the year ended December 31, 2023 and
2022, respectively.
• Loss per share before and after dilution amounted to SEK
8.69 and SEK 7.78 for the year ended December 31, 2023
and 2022, respectively.
• For the year ended December 31, 2023 no dividend is
proposed.
Expected key events
upcoming 6 months |
| Calliditas Therapeutics | Year-End Report 2023: January – December 3
Calliditas
– pioneering new
treatments for rare
diseases
Our values
Calliditas Therapeutics leverages scientific expertise and disease-specific insights to help improve the lives of patients. We are a
commercial-stage biopharma company that researches, develops and
commercializes novel therapies that seek to address significant unmet
needs in relation to the treatment of rare diseases. We are commit-ted to expanding treatment options and establishing new standards
of care for patients with rare diseases, reflected by our pipeline of
innovative medicines that target unmet medical needs.
Our lead product provides a treatment option that has been demon-strated to be disease-modifying for IgA nephropathy (IgAN) – also
known as Berger’s Disease – a progressive autoimmune disease of
the kidney that for many patients leads to end-stage renal disease
(ESRD), requiring dialysis or organ transplantation. This drug product,
developed under the name Nefecon®, was granted accelerated
approval by the FDA in 2021 and full approval in December 2023,
and is today marketed in the US under the brand name TARPEYO®.
TARPEYO is now the first and only fully FDA-approved treatment for
IgAN based on a measure of kidney function. Nefecon has also been
granted conditional marketing authorisation by the European Com-mission under the brand name Kinpeygo® in the European Economic
Area (EEA) and in the UK. Kinpeygo is currently being reviewed for
full marketing authorization by the European Commission.
Nefecon has also been granted conditional approval in China and
approval in Macau and is being reviewed by regulators in Singapore,
Hong Kong and South Korea. Calliditas has also recently entered into
a partnership to develop and commercialize Nefecon in Japan.
AGILITY
We are flexible and able to rapidly pivot and adapt to
changing situations and requirements.
EXPERTISE
We leverage our strong internal experience and com-petencies while complementing our strengths through
knowledge sharing and external collaborations as
needed.
INTEGRITY
We take responsibility for our actions and hold ourselves
to the highest ethical standards, guided by our moral
principles to make the right decisions.
PIONEER
We explore novel approaches and empower each other
to find new ways of operating in a compliant, innovative
and pragmatic manner.
IgA nephropathy is the most common primary glomerulonephritis
worldwide, so the market potential for Nefecon is substantial,
as evidenced by our early commercial success and out-licens-ing deals with potential payments exceeding USD 300 million,
encompassing upfront payments and predefined milestones, as well
as ongoing royalty obligations.
Our late-stage pipeline is based on a first-in-class platform of
NOX inhibitors. Our lead compound, setanaxib, inhibits enzymes
involved in inflammation and fibrosis pathways and is the first
drug of this class to reach the clinical stage. Setanaxib is currently
undergoing clinical trials targeting rare diseases characterized by
inflammation and fibrosis, including IPF and PBC, and Calliditas has
also launched a trial with setanaxib in Alport syndrome. Additionally,
based on promising preclinical findings, we are conducting a proof-of-concept trial in head and neck cancer to further support the mode of
action of this drug class.
While our headquarters is in Stockholm, Sweden, we maintain a sig-nificant presence in the United States, with offices in New York and
New Jersey. We also have offices in France and Switzerland, where
our discovery team is based. Calliditas Therapeutics ordinary shares
were listed on NASDAQ Stockholm in 2018 (CALTX) and subse-quently American Depositary Shares representing our ordinary shares
were listed on the NASDAQ Global Select Market in the United
States in 2020 (CALT). |
| Calliditas Therapeutics | Year-End Report 2023: January – December 4
Key figures
Investment highlights
Oct–Dec Jan–Dec
(SEK in thousands, except per share amount or as otherwise indicated) 2023 2022 2023 2022
Net sales 451,561 429,042 1,206,888 802,879
Of which TARPEYO product sales 347,308 167,258 1,075,829 372,247
Operating income (loss) 41,765 32,495 (373,055) (421,943)
Income (loss) before Income tax for the period (14,256) 10,066 (457,017) (409,417)
Earnings (loss) per share before and after dilution (SEK) (0.34) (0.07) (8.69) (7.78)
Cash flow from (used in) operating activities 22,845 230,029 (434,655) (311,354)
As of
(SEK in thousands, except per share amount or as otherwise indicated) 31.12.2023 31.12.2022
Total registered shares, including shares held by Calliditas, at the end of the period 59,580,087 59,580,087
Equity attributable to equity holders of the Parent Company at the end of the period 334,806 766,264
Equity ratio at the end of the period in % 18% 39%
Cash at the end of the period 973,733 1,249,094
RECENT AND ANTICIPATED VALUE DRIVERS
NEFECON
Setanaxib
Positive readout
of pivotal Ph3
(NeflgArd) data
Biomarker data readout
from Ph2 PoC trial in Solid
Tumors (SCCHN)
Ph2 trial in Alport
Syndrome initiated
Full data readout
of Ph2 trial in Solid
Tumors (SCCHN)
Full data readout
of Ph2 IPF trial
Topline data readout
of Ph2b trial in PBC
Filed for full approval
in the US & Europe Approval in China
for partner Everest
Medicines
Full approval for TARPEYO
granted in US – the first ever
full approval in IgAN
Potential full
approval in Europe
for partner STADA
H1 2023 H2 2023 H1 2024 H2 2024
Partnering
activities in Oncology,
subject to data
Anticipated growth of
commercial franchise in
China & Europe
Granted new IP to
extend US protection
of TARPEYO
through 2043
Open label
extension
study data
readout
Update
to KDIGO
guidelines
Commercial
launch in China
Lancet published full
data from completed
Ph3 NeflgArd trial |
| Calliditas Therapeutics | Year-End Report 2023: January – December 5
CEO STATEMENT
On December 20th, 2023, we were granted full approval by the
FDA for TARPEYO, our treatment targeting the origin of primary IgA
nephropathy. This was a crowning achievement after many years of
striving to bring an approved disease modifying treatment to patients
with this rare disease. The new label for the US with the indication
reduction of kidney loss and the ability to address the full adult IgAN
population at risk of disease progression is a significant and positive
event for both patients and physicians. As previously reported, the
Phase 3 trial successfully met its primary endpoint (p< 0.0001) and
provided evidence that 9 months of treatment with Nefecon 16 mg/
day led to a significant reduction of kidney function loss, which was
preserved over the 15 months of observation off drug following
treatment. In addition, a durable reduction in proteinuria was observed
for the entire period and there was a statistically significant effect on
microhematuria as well as on biomarkers such as GdA1. We believe
these results support disease modification with the potential to pro-vide a clinically meaningful delay in the need for dialysis or transplanta-tion, and we are delighted that our sales force is now able to share the
exciting and important data from our full Phase 3 study with treating
physicians in the US.
In November we reported on several important events, including our
presentations at the annual Kidney Week Conference organized by
ASN (American Society of Nephrology), which this year was held in
Philadelphia. At the conference we also presented several posters,
including the modelling of the 2-year eGFR slope from the NefIgArd
Phase 3 trial predicting long term clinical benefit in a real-world popu-lation, adding to the already substantial scientific evidence supporting
the potential disease modification of TARPEYO. We also had the op-portunity to meet with over 100 nephrologists who provided valuable
insight into treatment paradigms and how TARPEYO is being used in
practice. It was incredibly rewarding to hear all of the positive stories
about patient outcomes and the difference that this medication is hav-ing on young adults previously facing an uncertain future and the risk
of ending up in dialysis. It was also clear that the publication of the
RaDaR registry data and similar longitudinal data from the southern
California IgAN cohort of Kaiser Permanente had a profound impact
on how the nephrology community was starting to think about this pa-tient population. The data reflected faster progression than expected
and significantly higher observed risk for progression amongst patients
previously considered “stable” or “controlled”. This data, in combination
with recently published clinical trial data showing significant eGFR
decline amongst patients on optimized RAS blockade, clearly reflects
a more serious outlook for patients with this condition than previously
thought. Nephrologists are hence increasing their focus on the patho-physiology of IgAN and on treating the underlying cause of the disease
to meaningfully impact eGFR, including prescribing TARPEYO, as the
only medication approved for IgAN based on kidney function.
Full approval for
TARPEYO in the US;
a year of successes
November also saw the conditional approval of Nefecon in China, a
major milestone considering the large patient population in China. We
also announced the Notice of Allowance for a new patent covering
TARPEYO, which significantly enhances product protection in the US
beyond 2029. We believe both of these events are highly impactful for
the long term value creation of the global Nefecon franchise and we
look forward to the commercial launch in China later this year.
The fourth quarter saw a significant increase in revenues as well as
over 50% growth in prescriptions over Q3, reflecting both improved
familiarity with the drug and the impact of the full data being published
in The Lancet in August. Total Q4 revenues were SEK 452 million, out
of which net revenues from TARPEYO amounted to SEK 347 million
(USD 32.6m). Total revenues for the year amounted to SEK 1,207
million out of which TARPEYO net revenues represented SEK 1,076
million, a growth of 189% over 2022. In Q4 we also posted a positive
cashflow from operating activities of SEK 23 million, a milestone
we had communicated early in the year and that we were excited to
achieve. Our cash position remains strong with SEK 974 million on the
balance sheet at the end of the year, supported by our positive cash
flow in Q4 and continued revenue growth expectations.
In December we announced the refinancing with Athyrium Capital
LP of our outstanding credit line in order to extend the interest-only
period beyond 2023. Due to our robust commercial franchise we were
able to achieve the same interest rate on an increased credit line. This
reflects the strength of our corporate profile, allowing us to leverage it
in order to have a balanced capital structure and avoiding sharehold-er dilution, whilst improving our cash position in challenging market
conditions.
We are extremely proud of what we have achieved as a team in 2023:
We delivered highly statistically significant data from our full Phase 3
trial, cementing our global leading position in IgAN, achieved another
breakthrough “first” by being granted full approval for TARPEYO in
the US with a new and broader label, significantly strengthened our
TARPEYO IP estate and achieved conditional approval for Nefecon
in China. In addition, we achieved net TARPEYO revenues in excess
of one billion Swedish krona, progressed our late-stage pipeline and
supported several key regulatory processes related to Kinpeygo and
Nefecon in Europe and Asia. I want to thank everybody at Calliditas for
their commitment, ingenuity, agility and hard work. It takes an amazing
team effort to deliver this kind of a score card in 12 months. It has
indeed been a busy and highly successful 2023 and we look forward
to an exciting 2024!
Renée Aguiar-Lucander, CEO |
| Calliditas Therapeutics | Year-End Report 2023: January – December 6
BUSINESS OVERVIEW
Our pipeline
Exciting journey ahead
Calliditas’ lead product, developed under the name Nefecon, has been approved in the US,
Europe, and China. Our pipeline consists of development programs based on a first-in-class NOX
inhibitor platform. The lead compound, setanaxib, is a selective NOX 1 and NOX 4 inhibitor and is the
first NOX inhibitor to reach the clinical stage. Calliditas is presently running trials with setanaxib in
primary biliary cholangitis (PBC), squamous cell carcinoma of the head and neck (SCCHN), and Alport
syndrome. There is also an ongoing investigator-led trial in idiopathic pulmonary fibrosis (IPF).
Expected commercial ramp
following full approval of
TARPEYO in primary IgA
nephropathy for patients at
risk of progression
1H 24: Full data from
phase 2 study in head and
neck cancer
Potential full approval of
Kinpeygo in EU and UK
NEFECON* Setanaxib
Preclinical Phase 1 Phase 2 Phase 3 Marketed Rights Commercial region
* Approved in the US under the tradename TARPEYO® to reduce the loss of kidney function in adults with primary IgAN at risk for disease progression, and granted condi-tional marketing authorization in the EEA and UK under the tradename Kinpeygo® for the treatment of primary IgAN in adults at risk of rapid disease progression with a urine
protein-to-creatinine ratio (UPCR) ≥1.5 g/gram, and granted conditional approval in China under the tradename Nefecon®.
Commercial Ongoing Trial Planned Trial Investigator Led Trial
IgAN Japan
IgAN United States
ROW ex partnered
IgAN
China, Hong Kong, Macau,
Taiwan, Singapore,
South Korea
IgAN KINPEYGO 4 mg Modified-release hard capsules
budesonide
Europe, UK, Switzerland
Global
SCCHN Global
IPF Global
Alport Global
PBC |
| Calliditas Therapeutics | Year-End Report 2023: January – December 7
BUSINESS OVERVIEW
Our commercial product
On December 20, 2023, Calliditas’ lead
product, TARPEYO, became the first and
only drug granted full approval by the US
Food and Drug Administration for patients
affected by IgA nephropathy (IgAN). It is
the only treatment specifically designed to
target the origin of IgAN and to be disease-modifying.
IgAN is a serious progressive disease, in which up to 50% of
patients end up at risk of developing end-stage renal disease
(ESRD) within ten to twenty years. This product, which was
developed under the name Nefecon®, is approved under the
brand name TARPEYO® in the United States. It was also granted
conditional approval by the European Commission under the
brand name Kinpeygo® in July 2022 and by the MHRA for the
UK in February 2023. Nefecon recieved conditional approval in
China by the China NMPA in November 2023.
Disease background
Although IgAN manifests in the kidney, the evidence indicates
that it is a disease that starts in the distal part of the intestine,
specifically in the ileum. Peyer’s patches, which are concen-trated within the gut-associated lymphoid tissue in the ileum,
have been identified as a major source of mucosal-type IgA
antibodies. Patients with IgA nephropathy have elevated levels
of mucosal-type IgA, which – in contrast to the majority of the
IgA in the blood – are predominately dimeric or polymeric and
are galactose-deficient. In IgAN patients, a combination of a
genetic predisposition and environmental, bacterial and dietary
factors is presumed to lead to an increased production of these
galactose-deficient IgA antibodies. This increased production,
potentially in conjunction with increased intestinal permeability,
leads to these secretory antibodies appearing in the blood.
Successful Phase 3 trial readout
NefIgArd is the first Phase 3 trial in IgA nephropathy to show a
statistically significant and clinically relevant kidney protective
effect as measured by eGFR. Calliditas’ full approval for Nefecon
from the FDA was based on the strong eGFR data from this trial.
The trial confirmed that targeting the origin of the disease with
a non chronic approach had a significant long-term impact on
kidney function.
The full Phase 3 NefIgArd trial consisted of a total of 364
patients, including 200 patients from the interim analysis, based
upon which Calliditas successfully filed for accelerated approval
with the FDA and for conditional approval with the European
Commission, UK MHRA, and China NMPA. The full trial included
9 months of treatment and a 15-month post-treatment obser-vational period for all study participants to confirm long-term
renal protection. The endpoint of the full Phase 3 trial assessed
the difference in kidney function between treated and placebo
patients, as measured by eGFR, over a two-year period from the
start of dosing of each patient. The data read-out took place in
March 2023, and in August 2023 was published in The Lancet.
The primary endpoint of the Phase 3 trial was a time-weighted
average of eGFR observed at each time point over two years.
The primary endpoint was successfully met with a highly statis-tical p value of <0.0001. At 9 months the absolute difference
in eGFR of the treatment arm was an improvement of 0.7
mL/min/1.73 m2 versus a loss of 4.6 mL/min/1.73 m2 for the
placebo arm. The treatment benefit was preserved during the
period of observation, reflected by a loss of kidney function at
two years in the placebo arm of 12.0 mL/min/1.73 m2 versus
6.1 mL/min/1.73 m2 for the treatment arm. This was also
confirmed by a difference in slope of 3 mL/min/year in favor of
TARPEYO.
There was a cumulative improvement in proteinuria in patients
treated with Nefecon versus placebo during the 9-month treat-ment period, which continued to significantly improve after end
of treatment, resulting in a decline of over 50% at 12 months.
At month 24, proteinuria levels in patients who had received
Nefecon were still at a reduced level, similar to that observed
at the 9-month time point, reflecting the durability of the
proteinuria reduction of a 9-month course of treatment.
Regulatory approvals
On the basis of this positive data, Calliditas submitted an
sNDA to the FDA seeking full approval of TARPEYO for the
complete study population from the Phase 3 NeflgArd study. On
December 20, 2023, the FDA approved TARPEYO (budesonide)
delayed release capsules to reduce the loss of kidney function in
adults with primary IgAN at risk for disease progression. Marking
a significant milestone, TARPEYO is now the first fully FDA-ap-proved treatment for IgAN reflecting the impact on a measure of
kidney function.
In September 2023, Calliditas’ partner STADA filed with Euro-pean Commission for full marketing authorisation of Kinpeygo in
the EU, and in October 2023 they also filed with the UK MHRA.
Nefecon received conditional approval in China in November
2023 and approval in the Macau administrative region in
October 2023. Calliditas’ partner Everest Medicines will be
commercialising this product in these territories. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 8
IgA nephropathy
- a significant market opportunity
Our commercial partnerships
• While IgAN is a rare disease, it is the most common
form of primary glomerulonephritis. Prevalence is es-timated to range from 130,000 to 150,000 patients in
the US, to be around 200,000 patients in Europe and
up to 5 million patients in China.
• In the United States, we estimate there are around
12,000 nephrologists, of which up to two thirds treat
patients with IgAN. The majority of patients are seen
by approximately 4,000 to 5,000 specialists. About
40% of the patients are treated in academic settings
while the remaining are treated in community settings.1
BUSINESS OVERVIEW
EU
Nefecon® was granted conditional
marketing authorisation (CMA) by the
European Commission in July 2022,
and subsequently by the Medicines and
Healthcare products Regulatory Agency
(MHRA) of the United Kingdom in February
2023, under the brand name Kinpeygo®
for the treatment of IgAN in adults at risk
of rapid disease progression with a urine
protein-to-creatinine ratio (UPCR) ≥1.5 g/
gram, becoming the first and only approved
treatment for IgAN in EU.
Kinpeygo will be marketed in the European
Economic Area (EEA), the UK and
Switzerland, if approved in this jurisdic-tion, exclusively by STADA Arzneimittel
AG, with whom Calliditas entered into a
license agreement in July 2021 to register
and commercialize Kinpeygo in Europe.
STADA launched Kinpeygo in Germany in
September 2022, with additional European
countries to follow.
Following the positive data readout from
the full NefIgArd trial, Calliditas is collab-orating with STADA on the application for
full approval of Kinpeygo by the European
Commission and the MHRA in the full
study population.
Greater China
Calliditas entered into a licensing agree-ment to develop and commercialize
Nefecon for IgAN in Greater China and
Singapore with Everest Medicines (HKEX
1952.HK) in 2019. In March 2022, this
agreement was expanded to include South
Korea.
The Chinese regulatory authority National
Medical Products Administration (NMPA)
granted Nefecon conditional approval for
the treatment of primary IgAN in adults at
risk of disease progression in November
2023. Nefecon has also been approved the
Pharmaceutical Administration Bureau of
the Macau Special Administrative Region.
• The IgAN patient population at risk of disease progression
as defined by KDIGO guidelines is estimated to amount
to between 45,000 and 60,000 patients in the US.2
• Today the majority of these patients are treated princi-pally with supportive care such as generic ACEs and/or
ARBs to control blood pressure, complemented with other
broadly indicated cardio and kidney protective drugs.
• As availability and familiarity of approved drugs
specifically indicated and approved for IgAN increase
and physicians consider more active intervention to
preserve kidney function, we estimate the global IgAN
market will grow to USD 5 – 8 billion.
Everest launched Nefecon in China’s
Hainan Boao Pilot Zone as a First-in-Dis-ease therapy for IgA nephropathy in April
2023. This program allows innovative
overseas drugs and medical devices that
have been approved in other territories
to be sold and used in real-world clin-ical settings in Hainan Province before
regulatory approval by the NMPA. Several
hundreds of patients signed up for this
early access program, making it one of the
most successful early access programs
launched in China.
Japan
At the end of 2022, Calliditas entered into
a partnership to commercialize Nefecon in
Japan with Viatris Pharmaceuticals Japan,
a subsidiary of Viatris Inc. (Nasdaq: VTRS).
Viatris is a global healthcare company which
is headquartered in the United States and
has a presence in over 165 countries and
territories, and also operates approximately
40 manufacturing facilities.
1Veeva OpenData for 2023, including all active HCPs where the primary specialty is Nephrology
2Spherix RealWorld Dynamix |
| Calliditas Therapeutics | Year-End Report 2023: January – December 9
TARPEYO: Moving from
supportive care to treating IgAN
BUSINESS OVERVIEW
Targeted B cell
immunomodulator
designed to local-ly target origin of
disease
In combination with
optimized RASi ther-apy; option of inter-mittent, rather than
chronic treatment
Durable eGFR benefit
and sustained pro-teinuria disease-mod-ifying effects in IgAN
Well characterized
active ingredient and
safety profile
Mechanism of action Patient focus Efficacy Safety
TARPEYO and Kinpeygo were the first-ever medications approved for IgAN by the FDA and
European Commission, respectively, and the only treatments specifically designed to target
the origin of IgAN and to be disease-modifying. TARPEYO is the only fully FDA-approved
treatment for IgAN and the only treatment approved based on protection of kidney function.
• A genetic predisposition is required
but not sufficient; most patients
are diagnosed in their 20s and 30s
• More than 50% are at risk of
developing ESRD within 10-20
years, leading to kidney transplant
• The treatment goal is to preserve
eGFR – kidney function
• Recently published longitudinal
data imply that disease progression
is faster and outlook worse than
previously thought1
IgAN Patients:
1 Pitcher D, Braddon F, Hendry B, et al. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727-738. doi:10.2215/CJN.000000000000013
Kwon CS, Daniele P, Forsythe A, Ngai C. A Systematic Literature Review of the Epidemiology, Health-Related Quality of Life Impact, and Economic Burden of Immunoglobulin A Nephropathy. J Health Econ Outcomes Res. 2021 Sep 1;8(2):36-45. doi: 10.36469/001c.26129. PMID: 34692885; PMCID:
PMC8410133. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 10
TARPEYO is now the first and only
therapy fully approved by the FDA in IgAN
BUSINESS OVERVIEW
In Q4, Calliditas reached a pivotal milestone with the historic FDA approval of TARPEYO on
December 20th, 2023, establishing it as the first and only approved treatment for reducing
the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN). The
FDA approval is for adults with primary IgAN at risk of disease progression, irrespective of
proteinuria levels, and sets a new standard in the treatment of IgAN.
In November, Calliditas showcased a strong presence at ASN
Kidney Week 2024 with investigators presenting additional
analyses of the Phase 3 NefIgArd trial highlighting statisti-cally significant and clinically meaningful treatment benefit of
TARPEYO.
These scientific presentations, coupled with our engagements
with key nephrology stakeholders, reflect our strategic efforts
Full FDA approval of
TARPEYO for the treatment
of IgAN
The first and only product to
reduce the loss of kidney func-tion in adults with IgAN
Advancing the science at ASN
7 abstracts presented at ASN.
Peer-reviewed publication on
Nefigan biomarker data. Strong
engagements with key opin-ion leaders, nephrologists, and
advocacy organizations to drive
education
Strengthened product
protection
A new patent for TARPEYO was
allowed. The patent was subse-quently included in the Orange
Book and is strengthening prod-uct protection until 2043.
Driving patient
engagements
Patient webinar on
TARPEYO with IgAN foun-dation. Launched patient
ambassador stories via social
media
QUARTERLY HIGHLIGHTS Q4
New prescriptions in Q4
YTD prescriptions: 1,753
51% QoQ growth
New Prescribers in Q4
LTD Prescribers: 1,639
53% QoQ growth
Net sales of TARPEYO in Q4
KEY METRICS Q4 2023
555 301 $32.6M
EXCITING JOURNEY AHEAD
The full FDA approval enables Calliditas to commercialize TARPEYO based on the new label and Phase 3 trial data
to address the full at-risk patient population, to broaden TARPEYO’s uptake and adoption with nephrologists, and to
establish its placement as an essential and foundational part of the new Standard of Care (SoC) for IgAN patients as a
disease-modifying therapy, designed to target an underlying cause of the disease.
in continuing to educate key stakeholders about TARPEYO and
driving scientific exchange.
During Q4 2024, TARPEYO saw over 50% quarter over quarter
growth in patient enrollments and new prescribers, with 555 new
prescriptions and 301 new prescribers, signaling strong market
acceptance and demand for this therapy. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 11
BUSINESS OVERVIEW
Calliditas’ pipeline consists of development
programs based on a first-in-class NOX inhib-itor platform. Calliditas is presently running
clinical trials with lead compound setanaxib in
squamous cell carcinoma of the head & neck
(SCCHN), which read out interim data in July
2023, as well as in primary biliary cholangitis
(PBC) and Alport syndrome.
NOX Enzyme Inhibitors
NOX enzymes, also known as nicotinamide adenine dinucleotide
phosphate (NADPH) oxidases, are the only known enzymes
that are solely dedicated to producing reactive oxygen species
(ROS). At appropriate concentrations, ROS help regulate cell
proliferation, differentiation, and migration, as well as modulate
the innate immune response, inflammation, and fibrosis.
The disruption of redox homeostasis has been implicated in
multiple disease pathways, with oxidative stress caused by excess
ROS being a likely underlying mechanism for many disorders,
including cardiovascular diseases, neurodegenerative disorders,
and cancer. As such, NOX enzyme inhibitors emerged as
promising novel experimental drugs in a new therapeutic class.
Setanaxib, which is the first NOX inhibitor to reach the clinical
stage, inhibits NOX1 and NOX4, enzymes that are implicated in
fibrosis and inflammation pathways and that represent a high-potential therapeutic target.
Alport syndrome
Alport syndrome is a genetic disorder arising from the muta-tions in the genes that code for type IV collagen. The type IV
collagen alpha chains are primarily located in the kidneys, eyes,
and cochlea, and thus the condition is characterized by kidney
disease, loss of hearing, and eye abnormalities. Eventually,
patients present with proteinuria, hypertension, progressive loss
of kidney function (gradual decline in GFR), and ESRD.
It is estimated that approximately 67,000 people in the United
States have this disorder, and it is a significant cause of chronic
kidney disease (CKD), leading to ESRD in adolescents and young
adults and accounting for 1.5% to 3.0% of children on renal
replacement therapies in EU and the US.
Pipeline: NOX Inhibitor platform
Based on supportive pre-clinical work, Calliditas launched
a randomized, placebo-controlled Phase 2 study in Alport
syndrome including around 20 patients. The study will eval-uate overall safety as well as impact on proteinuria. The study
was initiated in November 2023 and on the basis of the data
readout we will decide on a full regulatory program in Alport.
Calliditas was granted orphan drug designation for the
treatment of Alport syndrome with setanaxib by the FDA in
September 2023, and by the EMA in November 2023.
Primary biliary cholangitis
PBC is a progressive and chronic autoimmune disease of the
liver that causes immune injury to biliary epithelial cells, resulting
in cholestasis and fibrosis. It is an orphan disease and, based on
its known prevalence rates, we estimate that there are approxi-mately 140,000 patients in the United States, where the annual
incidence ranges from 0.3 to 5.8 cases per 100,000. Calliditas
received FDA Fast Track Designation for setanaxib in PBC in
August 2021.
Ursodeoxycholic acid, a generic drug also known as ursodiol or
UDCA, and obeticholic acid, known as Ocaliva, are the only treat-ments for PBC approved by the FDA. However, despite these
treatment options, there is still an unmet medical need among
PBC patients, in particular when it comes to important quality of
life outcomes.
Phase 2 data from a trial with setanaxib in 111 patients with PBC
demonstrated that setanaxib had a more pronounced effect on
fibrosis and ALP reduction (alkaline phosphatase, an established
independent predictor of prognosis in PBC) in patients with
an estimated liver fibrosis stage of F3 or higher. Patients with
elevated liver stiffness are at greater risk of disease progression.
Calliditas is conducting a randomized, placebo-controlled, double-blind Phase 2b trial in PBC patients with elevated liver stiffness
We are expecting to read out data from approximately 75
patients in mid-2024. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 12
BUSINESS OVERVIEW
Phase 2 Proof-of-Concept study: Interim data
readout
In July 2023, Calliditas read out interim data from the trial,
which reflected encouraging early clinical progression-free
survival (PFS) results and supports the presumed anti-fibrotic
mode of action of setanaxib. The basis for the analysis consisted
of data from 20 patients with recurrent or metastatic SCCHN,
of which 16 patients had evaluable tumor size and PFS-related
results.
Twelve patients had tumor biopsies before and after treatment
that were evaluable. The biomarker analysis included transcrip-tomic analysis and evaluated pathology markers such as SMA,
Foxp3 regulatory T cells and PDL-1 Combined Positive Score. In
terms of PFS, 7 out of the 16 evaluable patients were progres-sion-free with either stable disease or partial response, of which
6 were in the setanaxib arm and 1 was in the placebo arm. Six
of the 7 patients were still on the study drug at the time of the
data readout, with the longest period on drug being reported as
21 weeks, related to a patient in the setanaxib arm.
Setanaxib in squamous cell carcinoma of the head
and neck
Calliditas is evaluating setanaxib in head and neck cancer, building
on promising in vivo preclinical data that suggests that setanaxib
could significantly enhance the effects of immune-oncology thera-pies. We are conducting a double-blind, randomized, placebo-con-trolled, proof-of-concept Phase 2 study, which is investigating
the effect of setanaxib 800mg twice daily in conjunction with
pembrolizumab 200mg IV, administered every 3 weeks, in at least
50 patients with relapsed or metastatic SCCHN and tumors with
moderate or high levels of cancer-associated fibroblasts.
Pipeline: NOX Inhibitor platform
28 days
No treatment
Screening Treatment Follow up
~50 Patients
≤ 28 Days
Tumor accessible for
tissue biopsy
Positive CAF level
(defined as CAFs level
in tumors ≥5%)
No treatment
Randomized, Double-Blind
All Enrolled Patients
Tumor Biopsy
9 weeks
(±1 week)
Pembrolizumab 200mg IV, every 3 weeks
Setanaxib 800mg PO, twice daily
Matching placebo
CAF = Cancer-Associated Fibroblast
IV = Intraveneously
PO = Per os (orally)
Randomization
A tumor biopsy will be taken prior to randomization and again
after approximately 9 weeks of treatment. Treatment will continue
until unacceptable toxicity or disease progression, in keeping with
standard practice for oncology trials. Calliditas read out interim data
from the study in July 2023 and expects to read out final trial data
in 1H 2024.
Further details of this study can be found at www.clinicaltrials.gov, with the
reference NCT05323656.
The transcriptomic analysis showed that the two top pathways
impacted by the treatment were fibrosis‑related signalling
pathways (the Idiopathic Pulmonary Fibrosis Signalling Pathway
and Hepatic Fibrosis/Hepatic Stellate Cell Activation Pathway),
providing support for the presumed mode of action on activated
cancer associated fibroblasts in head and neck cancer, as well as
a potential anti-fibrotic effect in Calliditas’ other ongoing clinical
programs.
Pathology analysis showed preliminary evidence of an increase
in immunological activity within tumors of patients treated with
setanaxib, with favorable changes in Foxp3 and PDL-1 CPS. As
SMA levels at baseline were not balanced between the groups,
and tumor biopsy samples were generally small, it was not
possible to draw any conclusions regarding setanaxib’s impact
on SMA reduction. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 13
INTERVIEW WITH FRANK BRINGSTRUP
Calliditas
Vice President
Regulatory Affairs
Frank Bringstrup
Last year, Calliditas filed for full approval of TARPEYO with
the FDA. What was that process like? How were you able
to get such a fast turnaround between the data readout in
March and the filing a few months later in June?
Our submission team was motivated and forward leaning, and as
a result of a great team effort the filing to FDA for full approval
of TARPEYO® was successfully completed ahead of time. We
managed to compress the timelines by frontloading the submis-sion document writing as the clinical study results became avail-able, finalising interdependent documents and adding individual
documents to the electronic submission dossier as they became
available.
Considerations from a commercial perspective based on the data
were included and implemented in the storyline for the high-level documents, so that the turn-around for the submission
was fast, and at the same time we could ensure that the dossier
would be optimised for negotiations for a competitive label.
A request for Priority Review was included with the filing for full
approval and was granted by FDA, and this, in combination with
the early submission, enabled an approval date in December
2023.
Our regulatory team has also been supporting STADA
with its filing with EMA and the UK MHRA – how has that
process been going?
Since June 2023, our regulatory team has been supporting
STADA with its filing to the EMA and the MHRA for full
approval and to fulfil the ‘Specific Obligation’ from the condi-tional approval. We aligned on a specific filing strategy with
STADA before its submission, and some of the documents for
the submission were prepared and provided to STADA by the
Calliditas team. The EMA/CHMP review and UK MHRA review
are ongoing.
How did the regulatory team support its partner Everest
Medicines in its successful filing with the China NMPA?
The documents for the China NDA filing were prepared in close
collaboration between the Calliditas and Everest regulatory
teams, and in October 2022 the NDA was submitted by Everest
to the CDE/NMPA with Calliditas as the applicant. In November
2022 the NDA was accepted for review by CDE/NMPA, and in
December 2022 the NMPA granted Priority Review of Nefecon
for the treatment of primary immunoglobulin A nephropathy
(IgAN) in adults at risk of rapid disease progression.
From the outset of the China NDA review process, an internal
Calliditas-Everest pre-defined ‘Q&A’ process was put in place, so
as to ensure that we could collaborate on an optimal response
strategy for any questions from the regulatory authority to effec-tively manage the response preparations. This regulatory ‘Q&A
phase’ was managed successfully, and in November 2023 the
NMPA approved Nefecon® for the treatment of primary IgAN in
adults at risk of disease progression.
You have been VP of Regulatory Affairs at Calliditas since
2019, and have overseen an incredibly exciting time,
including the initial approvals of TARPEYO and Kinpeygo
and now full approval for TARPEYO. What has been your
chief focus as leader in this role?
My primary focus has been to get fast to the market with first
cycle approvals and competitive labelling. Reducing the time
to market for medicines treating a serious disease like IgAN is
critical for patients, as well as for the product and for Calliditas’
success. Execution of our strategy is a key part of our success. It
has been incredibly exciting to successfully bring to market the
first approved product for IgAN patients. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 14
Continued focus on sustainability:
Defining material matters
Calliditas Therapeutics | Year-End Report 2023: January – December
For Calliditas to strategically carry out
the relevant sustainability efforts and
the sustainability reporting that meets
transparency and accuracy requirements,
the Company must be well acquainted
with its most important sustainability
matters from an environmental, social and
corporate perspective.
The assessment was performed in accordance with the increased
EU requirements on sustainability reporting – the Corporate
Sustainability Reporting Directive (CSRD) and the associated
mandatory reporting standards, the European Sustainability
Reporting Standards (ESRS). Calliditas will be subject to the new
requirements in its reporting for the 2025 financial year.
Double materiality assessment
In the first step of the assessment, a gross list was prepared
with Calliditas’ potential material sustainability matters. Each
sustainability matter on the gross list was then evaluated based
on its impact on people and the environment and its impact on
Calliditas’ financial position. The assessment was performed by
external experts in consultation with senior executives at Callid-itas with knowledge of the specific relevant matters.
The result from the assessment of each sustainability matter
was illustrated in a matrix and validated by a group of people
with similar positions and knowledge in the various areas. The
thresholds used to determine the material areas were defined
and validated in this group and approved by the CEO.
Example: Corruption and bribery
The industry in which Calliditas operates has historically been
subject to an increased risk of corruption and bribery. This was
sufficient reason to include this sustainability matter on the gross
list. It was established in the assessment that, while there are no
actual cases of corruption, corruption remains a potential risk.
When a potential case of corruption was evaluated based on its
impact on Calliditas as a company and its impact on people and
the environment, it was found that even though the likelihood of
such an incident was considered to be low, the risks were high
enough for the matter to be assigned a relatively high compara-tive figure.
SUSTAINABILITY
Calliditas’ material sustainability matters
The methodically performed double materiality assessment
showed that Calliditas’ sustainability impact can be found in
seven main areas. These areas were then categorized depending
on whether the impact is environmental, social or governmental.
Going forward, these material sustainability matters will govern
Calliditas’ strategic sustainability efforts and sustainability
reporting.
Environmental matters
• Climate change is an important issue, given its global scope
and impact as an issue that affects everyone to some extent.
• Circular economy and waste are relevant issues to Callid-itas, as Calliditas produces relevant amounts of waste in the
course of carrying out its preclinical and commercial activi-ties. The requirements dictating the proper packaging of its
drug product also limit the possibilities for circularity.
Social matters
• The health and safety for our own workforce is an area in
which the company has a material impact, as well as being
one that Calliditas has a high degree of control over.
• For Calliditas to have a positive impact on the health of
patients, its products must be accessible to end users.
• The safety and quality of the product is hugely important,
both for patients’ health and for Calliditas’ credibility.
Governance matters
• The industry in which Calliditas operates has historically
been exposed to an increased risk of corruption and bribery.
Calliditas takes this seriously, as it may potentially have major
impact.
• The management of animal welfare is particularly important
given that Calliditas engages in animal testing.
14
“The methodically performed double materiality
assessment showed that Calliditas’ sustainability impact
can be found in seven main areas. These areas were
then categorised depending on whether the impact is
environmental, social or governmental. Going forward,
these material sustainability matters will govern
Calliditas’ strategic sustainability efforts and
sustainability reporting.”
Åsa Hillsten
Head of IR & Sustainability |
| Calliditas Therapeutics | Year-End Report 2023: January – December 15
January – December 2023
FINANCIAL OVERVIEW
Revenue
Net sales amounted to SEK 451.6 million and SEK 429.0 million
for the three months ended December 31, 2023 and 2022,
respectively. Net sales for the year ended December 31, 2023
and 2022 amounted to SEK 1,206.9 million and SEK 802.9
million, respectively. Net sales primarily originate from net sales
of TARPEYO® in the US, which amounted to SEK 347.3 million
and SEK 167.3 million for the three months ended December
31, 2023 and 2022, respectively. For the year ended December
31, 2023 and 2022, net sales from TARPEYO amounted to SEK
1,075.8 million and SEK 372.2 million, respectively. Royalty
income from our partnerships amounted to SEK 14.0 million
for the three months ended December 31, 2023 and SEK 36.8
million for the year ended December 31, 2023. For both the
three months and the year ended December 31, 2022 the
royalty income from our partnerships amounted to SEK 2.3
million. Outlicensing of product amounted to SEK 82.7 million
and SEK 257.9 million for the three months ended December
31, 2023 and 2022, respectively. For the year ended December
31, 2023 and 2022, outlicensing of product amounted to SEK
82.7 million and SEK 421.7 million, respectively. For 2023,
outlicensing of product consisted of regulatory milestone fees
from Everest Medicines.
For additional information see Note 4.
Cost of Sales
Cost of sales amounted to SEK 22.3 million and SEK 7.9 million
for the three months ended December 31, 2023 and 2022,
respectively. For the year ended December 31, 2023 and 2022
cost of sales amounted to SEK 60.5 million and SEK 15.2 million,
respectively. The increase in the 2023 periods, was related to the
higher volume of product sales.
Total Operating Expenses
Total operating expenses amounted to SEK 387.5 million and SEK
388.7 million for the three months ended December 31, 2023 and
2022, respectively. For the year ended December 31, 2023 and
2022 total operating expenses amounted to SEK 1,519.5 million
and SEK 1,209.6 million, respectively.
Research and Development Expenses
Research and development expenses amounted to SEK 106.7
million and SEK 102.2 million for the three months ended
December 31, 2023 and 2022, respectively. For the year ended
December 31, 2023 and 2022 research and development
expenses amounted to SEK 502.2 million and SEK 414.7 million,
respectively. The increase of SEK 4.5 million for the three months
ended December 31, 2023 and the increase of SEK 87.5 million
for the year ended December 31, 2023, were primarily due to
increased clinical activities for the Nox-platform, including the
ongoing setanaxib trials. Included in the increase for the full year,
was the recognition of a one-time effect from the impairment of
SEK 32.1 million regarding in-licensing of Budenofalk.
Marketing and Selling Expenses
Marketing and selling expenses amounted to SEK 198.5 million
and SEK 191.9 million for the three months ended December 31,
2023 and 2022, respectively. For the year ended December 31,
2023 and 2022 marketing and selling expenses amounted SEK
727.7 million and SEK 515.2 million, respectively. The increases
of SEK 6.6 million for the three months ended December 31,
2023, and SEK 212.5 million for the year ended December 31,
2023, were primarily related to the increased costs for sales and
marketing of TARPEYO in the US, where marketing activities have
been intensified and the salesforce has been increased, compared
to the corresponding periods of the prior year.
Administrative Expenses
Administrative expenses amounted to SEK 94.6 million and SEK
81.0 million for the three months ended December 31, 2023 and
2022, respectively. For the year ended December 31, 2023 and
2022, administrative expenses amounted to SEK 333.0 million and
SEK 259.5 million, respectively. The increases of SEK 13.6 million
for the three months ended December 31, 2023, and SEK 73.5
million for the year ended December 31, 2023, were primarily
related to increased costs from a larger organization and increased
regulatory requirements.
Other Operating Incomes/Expenses, net
Other operating income (expenses), net amounted to SEK
12.3 million and (SEK 13.5 million) for the three months ended
December 31, 2023 and 2022, respectively. For the year ended
December 31, 2023 and 2022 other operating income (expenses),
net amounted to SEK 43.5 million and (SEK 20.2 million),
respectively. The improvement in both periods was primarily
attributable to movements in exchange rates related to operating
receivables and liabilities.
Net Financial Income and Expenses
Net financial income (expenses) amounted to (SEK 56.0 million)
and (SEK 22.4 million) for the three months ended December
31, 2023 and 2022, respectively. For the year ended December
31, 2023 and 2022, net financial income (expenses) amounted
to (SEK 84.0 million) and SEK 12.5 million, respectively. The
decrease of SEK 33.6 million for the three months ended
December 31, 2023, and SEK 96.5 million for the year ended
December 31, 2023 were primarily derived from interest
expenses and fees related to borrowing and currency effects
primary related to translation effects. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 16
FINANCIAL OVERVIEW
Tax
Total tax income (expense) amounted to (SEK 4.1 million) and
(SEK 13.7 million) for the three months ended December 31,
2023 and 2022, respectively. For the year ended December
31, 2023 and 2022, total tax income (expense) amounted to
(SEK 9.2 million) and (SEK 2.9 million), respectively. For the
year ended December 31, 2023, the increased tax expense was
primarily explained by taxable income for the US subsidiaries.
The Group’s tax losses carried-forward have not been
recognized as deferred tax assets, other than to the extent such
tax losses can be used to offset temporary differences.
Result for the period
For the three months ended December 31, 2023 and 2022, loss
for the period amounted to SEK 18.4 million and SEK 3.7 million,
and the corresponding loss per share before and after dilution
amounted to SEK 0.34 and SEK 0.07, respectively. For the
year ended December 31, 2023 and 2022, loss for the period
amounted to SEK 466.2 million and SEK 412.3 million, and the
corresponding loss per share before and after dilution amounted
to SEK 8.69 and SEK 7.78, respectively.
Cash Flow and Cash Position
Cash flow from operating activities amounted to SEK 22.9
million and SEK 230.0 million for the three months ended
December 31, 2023 and 2022, respectively. For the year ended
December 31, 2023 and 2022, cash flow used in operating
activities amounted to SEK 434.7 million and SEK 311.4 million,
respectively. The decrease in the periods is mainly attributable to
the change in current receivables.
Cash flow used in investing activities amounted to SEK
2.4 million and SEK 1.5 million for the three months ended
December 31, 2023 and 2022, respectively. For the year ended
December 31, 2023 and 2022, cash flow used in investing activ-ities amounted to SEK 13.7 million and SEK 5.1 million, respec-tively. The increase for both periods was primarily explained by
acquisition of equipment.
Cash flow from financing activities amounted to SEK 208.5
million and SEK 282.6 million for the three months ended
December 31, 2023 and 2022, respectively. For the year
ended December 31, 2023 and 2022, cash flow from financing
activities amounted to SEK 199.7 million and SEK 576.0 million,
respectively. The decrease in the periods is mainly attribut-able to reduced net borrowing compared to the same periods
previous year.
Net increse (decrease) in cash amounted to SEK 229.0 million
and SEK 511.2 million for the three months periods ended
December 31, 2023 and 2022, respectively, and (SEK 248.8
million) and SEK 259.5 million for the year ended December
31, 2023 and 2022, respectively. Cash amounted to SEK 973.7
million and SEK 1,249.1 million as of December 31, 2023 and
2022, respectively.
Personnel
The average number of employees were 192 and 100 for the
three months ended December 31, 2023 and 2022, respectively
and 181 and 86 employees for the year ended December 31
2023 and 2022, respectively.
Changes in Shareholders’ Equity and Number of
Shares
Equity attributable to equity holders of the Parent Company
amounted to SEK 334.8 million and SEK 766.3 million as of
December 31, 2023 and 2022, respectively. The number of
registered shares amounted to 59,580,087 and 59,580,087 as
of December 31, 2023 and 2022, respectively.
Treasury Shares
As of December 31, 2023, Calliditas had 5,908,018 ordinary
shares held as treasury shares by the Parent Company. At the
Annual General Meeting in 2023, authorization was given that
Calliditas can transfer (sale) these ordinary shares with the
purpose to finance an acquisition of operations, to procure
capital to finance the development of projects, repayment of
loans or to commercialize Calliditas’ products. See Note 7 for
further information.
Incentive Programs
During the three months ended December 31, 2023, 450,000
options have been allocated for the ESOP 2023 Program. For
more information on incentive programs, see Note 9.
Outlook 2024
For 2024, Calliditas expects continued revenue growth:
Total net sales are estimated to be USD 150-180 million for the year
ending December 31, 2024.
Parent Company
Net sales for the Parent Company, Calliditas Therapeutics AB,
amounted to SEK 337.2 million and SEK 297.1 million for the
three months ended December 31, 2023 and 2022, respec-tively. For the year ended December 31, 2023 and 2022 net
sales amounted to SEK 805.6 million and SEK 549.0 million,
respectively. The increase in both periods ended December 31,
2023, is primarily attributable to higher volume of product sales
compared to the previous year.
Operating income amounted to SEK 101.1 million and SEK 86.7
million for the three months ended December 31, 2023 and 2022,
respectively. For the year ended December 31, 2023 and 2022
operating loss amounted to SEK 167.8 million and SEK 215.4
million, respectively. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 17
Significant Events
FINANCIAL COMMENTS
Significant Events During the Period
October 1 – December 31, 2023
• On October 3, Calliditas announced filing with UK MHRA for
Kinpeygo in IgA nephropathy.
• On October 5, The European Medicines Agency Committee
for Orphan Medicinal Products provided positive opinion on
Calliditas’ application for setanaxib in Alport syndrome.
• On October 23, Calliditas announced the Nomination Committee
for the AGM 2024 was appointed. The Nomination Committee
consists of Patrick Sobocki, appointed by Stiftelsen Industri-fonden, Karl Tobieson, appointed by Linc AB, Spike Loy, appointed
by BVF and Elmar Schnee (chairman of the board of directors).
• On October 27, Calliditas announced that its commercial
partner Everest Medicines received approval for Nefecon for the
Treatment of Primary IgA Nephropathy from the Pharmaceutical
Administration Bureau of the Macau Special Administrative
Region, China.
• On November 24, Calliditas’ partner Everest Medicines
announces China NMPA’s conditional approval of Nefecon for
the treatment of primary IgA nephropathy.
• On 1 December, Calliditas announced that the company had
added Head of Technical Operations Lars Stubberud to its
mangement team. Additionally, the company added Brian
Gorman as its new Group General Counsel replacing Jonathan
Schur with changes taking effect on January 1, 2024.
• On 11 December, Calliditas announced that it has received a
Notice of Allowance from the United States Patent and Trade-mark Office (USPTO) for patent application no. 18/100,396
entitled “New Pharmaceutical Compositions.”
Significant Events After the end of the Period, 2024
• On January 7, Calliditas announced that Maria Törnsén was
appointed to the position of President North America with
immidiate entry into service. Ms Törnsén will be responsible for all
US based operations and will report to the CEO.
• On February 13 Calliditas announced that the United States
Patent and Trademark Office (USPTO) issued patent no.
11896719, entitled “New Pharmaceutical Compositions, on
January 24, 2024 with validity as of February 13, 2024. The
patent was subsequently included in the Orange Book. This is
Calliditas’ second patent for TARPEYO in the United States and
provides product protection until 2043.
• On December 20, the United States (US) Food and Drug Admin-istration (FDA) granted Calliditas full approval of TARPEYO®
(budesonide) delayed release capsules to reduce the loss
of kidney function in adults with primary immunoglobulin A
nephropathy (IgAN) who are at risk for disease progression.
• On December 27, Calliditas announced that the company had
signed and fully drawn a term loan of 92 million Euros with funds
managed by Athyrium Capital Management, LP (“Athyrium”).
Proceeds from the loan has fully replayced the company’s
previous 68 million Euro loan with Kreos Capital. |
| Calliditas Therapeutics | Year-End Report 2023: January – December 18
FINANCIAL COMMENTS
Ten largest shareholders as of December, 2023 %
BVF Partners LP 10,51
Linc AB 10,01
Stiftelsen Industrifonden 5,28
Polar Capital 3,90
Avanza Pension 3,52
Unionen 3,31
Handelsbanken Fonder 2,98
Fjärde AP-fonden 2,94
Sofinnova Partners 2,36
Öhman Fonder 2,23
Subtotal, 10 largest shareholders 47,04
Treasury shares 9,92
Other shareholders 43,04
Total 100.00
Executive Management
The Executive Management of Calliditas Therapeutics
AB consists of: CEO Renée Aguiar-Lucander, CFO Fredrik
Johansson, CMO Richard Philipson, Group General Counsel
Brian Gorman, President North America Maria Törnsén, Vice
President Regulatory Affairs Frank Bringstrup, Head of Techincal
Operations Lars Stubberud and Head of Human Resources
Sandra Frithiof.
Dividend
Any future dividend and the size thereof, will be determined
based on long-term growth, earnings trends and capital require-ments of Calliditas. The Board of Directors does not intend to
propose any dividend before the company generates long-term
sustainable income and positive cash flow. For the year ended
31 December 2023, no dividend is proposed.
Refinance of term loan
On December 27, 2023 Calliditas announced that the company
had signed and fully drawn a term loan of EUR 92 million with
funds managed by Athyrium Capital Management, LP. Proceeds
from the loan have been utilized for full repayment of the compa-ny’s loan with Kreos Capital of EUR 68 million.
Nomination Committee AGM 2024 appointed
On October 2023 Calliditas announced that the companys´
major owners have appointed a nomination committee for the
AGM 2024. The nomination committee consists of: Patrick
Sobocki, appointed by Stiftelsen Industrifonden, Karl Tobieson,
appointed by Linc AB, Spike Loy, appointed by BVF, and Elmar
Schnee (chairman of the board of directors). Shareholders who
wish to submit proposals to the nomination committee for the
annual general meeting 2024, can do so by e-mail to finance@
calliditas.com. Proposals should be submitted to the nomination
committee before March 15, 2024.
The Share
As of December 31, 2023, the number of shares amounted to
59,580,087 ordinary shares, of which, 5,908,018 are held as
treasury shares by the Parent Company. As of December 29,
2023, the closing price for the Calliditas Therapeutics share
CALTX was SEK 127.1. The total number of shareholders as of
December 31, 2023 was approximately 19,000.
Annual General Meeting 2024
The 2024 Annual General Meeting will be held May 13 at 14.00
p.m. CET, Klarabergsviadukten 90, Stockholm, Sweden. All docu-mentation is published on the companys´ website.
Shareholder Structure
Review
This interim report has not been subject to review by the
company’s auditors.
Stockholm 21 February, 2024
Renée Aguiar-Lucander |
| Calliditas Therapeutics | Year-End Report 2023: January – December 19
Presentation to investors,
analysts and press
For further information
please contact
Upcoming events
• Calliditas invites investors, analysts and press to a presentation of the
Year-end Report 2023 at 14:30 p.m CET on 21 February, 2024. The
report was published today at 7:00 a.m. CET.
• Calliditas’ CEO Renée Aguiar-Lucander will present the report together
with CFO Fredrik Johansson, CMO Richard Philipson and President
North America Maria Törnsén. The presentations will be given in English.
• Time: Tuesday 14:30 p.m. CET on 21 February, 2024
• Link to webcast
https://ir.financialhearings.com/calliditas-therapeutics-q4-report-2023
• To participate via conference call register via this link:
https://conference.financialhearings.com/teleconference/?id=50046870
After registration, you will receive a phone number and a conference ID
to log in to the conference call. Via the telephone conference, there is an
opportunity to ask oral questions.
ANNUAL REPORT 2023
Will be published digitally
April 2024
INTERIM REPORT Q1
January – March 2024
7 May
ANNUAL GENERAL MEETING 2024
Klarabergsviadukten 90, Stockholm
13 May
INTERIM REPORT Q2
January – June 2024
13 August
Renée Aguiar-Lucander / CEO
+46 (0)8 411 30 05
renee.lucander@calliditas.com
Åsa Hillsten / Head of IR & Sustainability
+46 (0) 764 03 35 43
asa.hillsten@calliditas.com
Supplemental Information
This interim report has not been reviewed or audited by the Company’s auditors.
The information in the Year-end report is information that Calliditas is obliged to make public pursuant
to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the
contact persons set out above, on February 21, 2024, at 7:00 a.m. CET.
Registered office
Calliditas Therapeutics AB
Kungsbron 1
SE 111 22 Stockholm, Sweden
calliditas.com / ir@calliditas.com
Forward looking statements
This Interim Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, statements regarding Calliditas’ strategy, business plans, revenue and other financial projections, and focus. The words “may,”
“will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this Interim Report are based on management’s current expectations and beliefs and are subject to a number of risks,
uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking
statements contained in this Interim Report, including, without limitation, any related to Calliditas’ business, operations, commercialization of TARPEYO
and Kinpeygo, clinical trials, supply chain, strategy, goals and anticipated timelines for development and potential approvals, competition from other
biopharmaceutical companies, revenue and product sales projections or forecasts, including 2024 total net sales guidance and cash runway, and other
risks identified in the section entitled “Risk Factors” in Calliditas’ reports filed with the Securities and Exchange Commission.
Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims
any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which
any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Any forward-looking statements contained in this Interim Report represent Calliditas’ views only as of the date hereof and should not be relied upon as
representing its views as of any subsequent date.
This Interim Report has been prepared in a Swedish original and has been translated into English. In case of differences between the two, the Swedish
version shall apply. |
| Calliditas Therapeutics | Year-End Report 2023: January - December 20
Condensed Consolidated Statements of Income
Three Months Ended December 31, Year Ended December 31,
(SEK in thousands, except per share amounts) Notes 2023 2022 2023 2022
Net sales 4 451,561 429,042 1,206,888 802,879
Cost of sales (22,299) (7,879) (60,463) (15,201)
Gross income 429,262 421,163 1,146,425 787,678
Research and development expenses (106,677) (102,239) (502,223) (414,749)
Marketing and selling expenses (198,542) (191,887) (727,740) (515,190)
Administrative expenses (94,624) (81,028) (332,991) (259,469)
Other operating income/(expenses), net 12,346 (13,514) 43,473 (20,212)
Operating income (loss) 41,765 32,495 (373,055) (421,943)
Net financial income/(expenses) (56,021) (22,428) (83,962) 12,526
Income (loss) before income tax (14,256) 10,066 (457,017) (409,417)
Income tax (4,112) (13,747) (9,168) (2,851)
Net income (loss) for the period (18,368) (3,681) (466,185) (412,268)
Attributable to:
Equity holders of the Parent Company (18,368) (3,681) (466,185) (412,268)
(18,368) (3,681) (466,185) (412,268)
Income (loss) per share before and after dilution (SEK) 8 (0.34) (0.07) (8.69) (7.78)
FINANCIAL STATEMENTS |
| Calliditas Therapeutics | Year-End Report 2023: January - December 21
Condensed Consolidated Statements of Comprehensive Income
Three Months Ended December 31, Year Ended December 31,
(SEK in thousands) 2023 2022 2023 2022
Net income (loss) for the period (18,368) (3,681) (466,185) (412,268)
Other comprehensive income
Other comprehensive income (loss) that may be reclassified to income or loss in subse-quent periods:
Exchange differences on translation of foreign operations (12,373) 1,661 (14,538) 36,287
Other comprehensive income (loss) that may be reclassified to income or loss in
subsequent periods
(12,373) 1,661 (14,538) 36,287
Other comprehensive income (loss) that will not be reclassified to income or loss in
subsequent periods:
Remeasurement gain (loss) on defined benefit plans (2,268) 387 (3,071) 2,763
Other comprehensive income (loss) that will not be reclassified to income or
loss in subsequent periods
(2,268) 387 (3,071) 2,763
Other comprehensive income (loss) for the period (14,640) 2,047 (17,609) 39,050
Total comprehensive income (loss) for the period (33,009) (1,634) (483,794) (373,218)
Attributable to:
Equity holders of the Parent Company (33,009) (1,634) (483,794) (373,218)
(33,009) (1,634) (483,794) (373,218)
FINANCIAL STATEMENTS |
| Calliditas Therapeutics | Year-End Report 2023: January - December 22
December 31,
(SEK in thousands) Notes 2023 2022
ASSETS
Non-current assets
Intangible assets 479,338 483,841
Equipment 16,053 7,468
Right-of-use assets 38,186 24,452
Non-current financial assets 24,201 11,210
Deferred tax assets 26,315 13,799
Total non-current assets 584,093 540,770
Current assets
Inventories 20,428 3,647
Current receivables 196,666 88,721
Prepaid expenses and accrued income 84,324 70,741
Cash 973,733 1,249,094
Total current assets 1,275,152 1,412,204
TOTAL ASSETS 1,859,245 1,952,973
EQUITY AND LIABILITIES
Equity
Equity attributable to equity holders of the Parent Company 334,806 766,264
Total equity 7,8,9 334,806 766,264
Non-current liabilities
Provisions 9 36,116 12,675
Contingent consideration 6 56,561 75,880
Deferred tax liabilities 41,641 39,752
Non-current interest-bearing liabilities 939,508 713,030
Lease liabilities 27,088 15,792
Other non-current liabilities 16,381 4,350
Total non-current liabilities 1,117,295 861,479
Current liabilities
Accounts payable 100,564 160,404
Other current liabilities 25,953 28,381
Accrued expenses and deferred revenue 280,627 136,446
Total current liabilities 407,144 325,231
TOTAL EQUITY AND LIABILITIES 1,859,245 1,952,973
Condensed Consolidated Statements of Financial Position
FINANCIAL STATEMENTS |
| Calliditas Therapeutics | Year-End Report 2023: January - December 23
Condensed Consolidated Statements of Changes in Equity
Year Ended December 31,
(SEK in thousands) 2023 2022
Opening balance equity attributable to equity holders of the Parent Company 766,264 1,008,281
Income (loss) for the period (466,185) (412,268)
Other comprehensive income (loss) (17,609) 39,050
Total comprehensive income (loss) for the period attributable to equity holders of the Parent Company (483,794) (373,218)
Transactions with owners:
Issuance of treasury shares - 236
Repurchase of treasury shares - (236)
Exercise of warrants - 95,121
Share-based payments 52,337 36,080
Total transactions with owners 52,337 131,201
Closing balance equity attributable to equity holders of the Parent Company 334,806 766,264
Closing balance equity 334,806 766,264
FINANCIAL STATEMENTS |
| Calliditas Therapeutics | Year-End Report 2023: January - December 24
Three Months Ended December 31, Year Ended December 31,
(SEK in thousands) 2023 2022 2023 2022
Operating activities
Operating income (loss) 41,765 32,495 (373,055) (421,943)
Adjustment for non-cash-items 24,054 30,916 102,478 61,260
Interest received 30,601 3,551 32,905 3,553
Interest paid (42,163) (11,576) (94,497) (35,252)
Income taxes paid (3,291) (2,675) (22,747) (7,392)
Cash flow from (used in) operating activities before changes in working capital 50,966 52,712 (354,915) (399,774)
Cash flow from (used in) changes in working capital (28,121) 177,318 (79,740) 88,420
Cash flow from (used in) operating activities 22,845 230,029 (434,655) (311,354)
Cash flow used in investing activities (2,354) (1,466) (13,745) (5,144)
Issuance of treasury shares - - - 236
Repurchase of treasury shares - - - (236)
Exercise of warrants - 31,476 - 95,121
New borrowings 962,889 255,282 962,889 491,745
Costs attributable to new loans (26,625) (1,260) (26,625) (1,260)
Repayment of borrowing (724,479) - (724,479) -
Repayment of lease liabilities (3,263) (2,861) (12,134) (9,615)
Cash flow from financing activities 208,522 282,638 199,650 575,990
Net increase (decrease) in cash 229,012 511,201 (248,750) 259,493
Cash at the beginning of the period 786,883 736,161 1,249,094 955,507
Net foreign exchange gains (loss) in cash (42,162) 1,732 (26,611) 34,094
Cash at the end of the period 973,733 1,249,094 973,733 1,249,094
Condensed Consolidated Statements of Cash Flows
FINANCIAL STATEMENTS |
| Calliditas Therapeutics | Year-End Report 2023: January - December 25
Condensed Parent Company Statements of Income
Three Months Ended December 31, Year Ended December 31,
(SEK in thousands) 2023 2022 2023 2022
Net sales 337,158 297,144 805,551 548,977
Cost of sales (22,283) (7,820) (60,399) (15,141)
Gross income 314,875 289,324 745,151 533,836
Research and development expenses (92,693) (97,724) (456,970) (384,453)
Marketing and selling expenses (107,211) (113,499) (402,436) (310,372)
Administrative expenses (79,948) (61,252) (273,359) (212,971)
Other operating income/(expenses), net 66,037 69,847 219,818 158,597
Operating income (loss) 101,060 86,696 (167,796) (215,364)
Net financial income/(expenses) (74,259) (6,525) (105,722) 6,816
Income (loss) before income tax 26,801 80,172 (273,518) (208,548)
Income tax - - - -
Income (loss) for the period 26,801 80,172 (273,518) (208,548)
Three Months Ended December 31, Year Ended December 31,
(SEK in thousands) 2023 2022 2023 2022
Income (loss) for the period 26,801 80,172 (273,518) (208,548)
Other comprehensive income (loss) - - - -
Total comprehensive income (loss) 26,801 80,172 (273,518) (208,548)
Condensed Parent Company Statements of Comprehensive Income
FINANCIAL STATEMENTS |
| Calliditas Therapeutics | Year-End Report 2023: January - December 26
Condensed Parent Company Balance Sheet
December 31,
(SEK in thousands) Notes 2023 2022
ASSETS
Non-current assets
Intangible assets - 32,132
Equipment 342 567
Non-current financial assets 1,125,186 887,456
Total non-current assets 1,125,528 920,154
Current assets
Inventories 20,428 3,647
Current receivables 223,700 129,090
Prepaid expenses and accrued income 67,603 61,092
Cash 817,871 1,059,655
Total current assets 1,129,602 1,253,485
TOTAL ASSETS 2,255,130 2,173,639
SHAREHOLDERS' EQUITY AND LIABILITIES
Shareholders' equity
Total restricted equity 5,475 5,475
Total non-restricted equity 904,299 1,125,480
Total shareholders' equity 7,9 909,774 1,130,956
Non-current liabilities
Provisions 9 25,924 9,512
Non-current interest-bearing liabilities 939,508 713,030
Other non-current liabilities 16,486 4,455
Total non-current liabilities 981,918 726,997
Current liabilities
Accounts payable 62,562 100,469
Other current liabilities 113,685 141,750
Accrued expenses and deferred revenue 187,191 73,468
Total current liabilities 363,438 315,686
TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES 2,255,130 2,173,639
FINANCIAL STATEMENTS |
| Calliditas Therapeutics | Year-End Report 2023: January - December 27
Note 1 - Description of Business
Calliditas Therapeutics AB (publ) (“Calliditas” or the “Parent Company”), with corporate registration number 556659-9766, and its
subsidiaries (collectively, the “Group”) conducts commercial and development activities in pharmaceuticals. These interim condensed
consolidated financial statements encompass the Group, domiciled in Stockholm, Sweden, and its subsidiaries for the year ended
December 31, 2023 and 2022.
Calliditas is a Swedish public limited company registered in and with its registered office in Stockholm. The registered address of the
corporate headquarters is Kungsbron 1, D5, Stockholm, Sweden. Calliditas is listed at Nasdaq Stockholm in the Mid Cap segment with
ticker “CALTX” and, in the form of ADSs, on the Nasdaq Global Select Market in the United States with the ticker “CALT”.
These interim condensed consolidated financial statements were approved by the Board of Directors (the “Board”) for publication on
February 21, 2024.
This report may include forward-looking statements. Actual outcomes may deviate from what has been stated. Internal factors such as
successful management of research projects, and intellectual property rights may affect future results. There are also external condi-tions, (e.g. the economic climate, political changes, and competing research projects) that may affect the Group’s results.
Note 2 - Accounting Policies
These interim condensed consolidated financial statements have been prepared in accordance with International Accounting Standard
No. 34 (IAS 34), “Interim Financial Reporting”. The Parent Company applies the Swedish Financial Reporting Board recommendation
RFR2, Accounting for legal entities. The accounting policies adopted in the preparation of the interim condensed consolidated finan-cial statements are consistent with those followed in the preparation of the Annual Report for 2022. None of the new or amended
standards and interpretations that became effective January 1, 2023, have had a significant impact on the Group’s financial reporting.
Significant accounting policies can be found on pages 49-54 of the Annual Report for 2022.
The ESMA (European Securities and Markets Authority) guidelines on alternative key performance ratios are applied, which means
disclosure requirements regarding financial measures that are not defined in accordance with IFRS. For key ratios not defined by IFRS,
see the Definitions and reconciliations of alternative performance measures on page 31.
Note 3 - Risks and Uncertainties in the Group and the Parent Company
Operational Risks
Research and drug development up to approved registration and marketing is subject to considerable risk and is a capital-intensive
process. The majority of all initiated projects will never reach market registration due to the technological risks, such as a failure to
demonstrate efficacy or a favorable risk/benefit profile, or manufacturing problems. Competing pharmaceuticals can capture market
share or reach the market faster, or if competing research projects achieve better product profiles, the future value of the product
portfolio may be lower than expected. The operations may also be impacted negatively by regulatory decisions, such as lack of approvals
and price changes.
Calliditas has a commercialized product, which has received full approval in the US. under the brand name TARPEYO and has received
conditional marketing authorization in the EU and the UK under the brand name Kinpeygo, and in China under the brand name
Nefecon, and are dependent on renual of the conditional marketing authorizations. There is a risk that commercialization will not go
according to plan or that the uptake of prescribing physicians will be worse than planned or that the drug will not have sufficient effect,
or show unwanted side effects, which may affect the sales negatively. The impact on the financial statements is described in the Finan-cial overview.
Financial Risks
Calliditas’ financial policy governing the management of financial risks has been designed by the Board of Directors and represents
the framework of guidelines and rules in the form of risk mandated and limits for financial activities. The Group is primarily affected
by foreign exchange risk, since the development costs for Nefecon and setanaxib are mainly paid in USD and EUR. Further, the Group
holds account receivables in USD and EUR and cash in USD and EUR to meet future expected costs in USD and EUR in connection
with commercialization of TARPEYO in the US and the clinical development programs. Regarding the Group and the Parent Company’s
financial risk management, the risks are essentially unchanged compared with the description in the Annual Report for 2022.
For more information and full disclosure regarding the operational and financial risks, reference is made to the Annual Report for 2022
and the Annual Report on Form 20-F, filed with the SEC in April 2023.
Notes to Condensed Consolidated Financial Statements
NOTES |
| Calliditas Therapeutics | Year-End Report 2023: January - December 28
Note 4 - Revenue from Contracts with Customers
Three Months Ended December 31, Year Ended December 31,
(SEK in thousands) 2023 2022 2023 2022
Type of goods or services
Product sales 354,855 168,882 1,087,418 375,516
Outlicensing of product 82,712 257,873 82,712 421,689
Royalty income 13,994 2,287 36,758 2,287
Performance of certain regulatory services - - - 3,387
Total 451,561 429,042 1,206,888 802,879
Geographical markets
USA 347,308 167,258 1,075,829 372,247
Europe 12,809 3,911 39,614 143,955
Asia 91,444 257,873 91,445 286,677
Total 451,561 429,042 1,206,888 802,879
Net sales for the periods primarily originate from net sales of TARPEYO in the US, which amounted to SEK 347.3 million and SEK 167.3
million for the three months ended December 31, 2023 and 2022, respectively. For the year ended December 31, 2023 and 2022,
net sales from TARPEYO amounted to SEK 1,075.8 million and SEK 372.2 million, respectively. Royalty income from our partnerships
amounted to SEK 14.0 million and SEK 2.3 million for the fourth quarter of 2023 and 2022, respectively. For the year ended December
31, 2023 and 2022, royalty income amounted to SEK 36.8 million and SEK 2.3 million respectively.
Outlicensing of product amounted to SEK 82.7 million and SEK 257.9 million for the three months ended December 31, 2023 and 2022
respectively, For the year ended December 31, 2023 and 2022, outlicensing of product amounted to SEK 82.7 million and SEK 421.7
million respectively. For 2023, outlicensing of product consisted entirely of regulatory milestone fees from Everest Medicines.
The total liability for expected returns and rebates amounts to SEK 39.9 million and SEK 24.3 million as of December 31, 2023 and
2022, respectively, which are recognized in total current liabilites.
Note 5 - Related-Party Transactions
During the reporting period, no significant related-party transactions have occurred.
For information about incentive programs please see Note 9.
Note 6 - Financial Instruments
The Group’s financial assets comprise of non-current financial assets, current receivables and cash, which are recognized at amortized
cost. The Group’s financial liabilities comprise of contingent consideration, non-current interest-bearing liabilities, other non-current
liabilities, lease liabilities, accounts payable, other current liabilities, and accrued expenses, all of which except contingent consideration,
are recognized at amortized cost. The carrying amount is an approximation of the fair value.
In the fourth quarter of 2023, Calliditas refinanced the existing term loan with a SEK 1,018.1 million senior secured facility with
Athyrium Capital. Proceeds from the loan have primarily been utilized for the full repayment of the company’s loan of SEK 724.5 million
with Kreos Capital. The fair value of the loan at the end of the period amounts to SEK 939,5 million. The credit agreement contains
financial covenants specifying minimum cash liquidity and minimum product revenue. The credit agreement contains customary affirma-tive and negative covenants for a senior secured loan.
Contingent consideration is recognized at fair value, measured at Level 3 of the IFRS value hierarchy. The fair value of the contingent consid-eration has been estimated in accordance with the present value method and the probability has been taken into account if and when the
various milestones will occur. The calculations are based on a discount rate of 12.2 percent. The most significant input affecting the valua-tion of the contingent consideration is the Group’s estimate of the probability of the milestones being reached. For the three months ended
December 31, 2023 and 2022, the income/(loss) for the period amounted to SEK 10.1 million and (SEK 11.8 million) respectively and for the
year ended December 31, 2023 and 2022, the affecting income/(loss) for the period amounted to SEK 18.8 million and (SEK 15.9 million),
respectively, which are recognized in other operating income/(expenses), net. This was mainly attributable to the change of study design for
the PBC project and revised timelines within the setanaxib platform. For more information see the Annual Report for 2022.
NOTES |
| Calliditas Therapeutics | Year-End Report 2023: January - December 29
Note 7 - Treasury Shares
As of December 31, 2023, Calliditas had 5,908,018 ordinary shares held as treasury shares by the Parent Company. At the Annual
General Meeting 2023, authorization was given that Calliditas can transfer (sale) these ordinary shares with the purpose to finance an
acquisition of operations, to procure capital to finance the development of projects, repayment of loans or to commercialize Calliditas’
products. No transfer (sale) of treasury shares have occurred as of December 31, 2023.
The total number of issued shares as of December 31, 2023, is presented in Note 8.
Note 8 - Shareholders’ Equity
December 31,
(SEK in thousands, except per share amounts and number of shares) 2023 2022
Total registered shares at the beginning of the period 59,580,087 52,341,584
New issue of shares during the period - 7,231,003
Shares subscribed but not registered during the period - 7,500
Total registered and subscribed but not registered shares at the end of the
period
59,580,087 59,580,087
Shares
Ordinary shares 59,580,087 59,580,087
Total 59,580,087 59,580,087
- of which shares are held by Calliditas 5,908,018 5,908,018
Total registered and subscribed but not registered shares at the end of the period, net of shares held by
Calliditas
53,672,069 53,672,069
Share capital at the end of the period 2,383 2,383
Equity attributable to equity holders of the Parent Company 334,806 766,264
Total equity at the end of the period 334,806 766,264
Three Months Ended December 31, Year Ended December 31,
(SEK in thousands, except per share amounts and number of shares) 2023 2022 2023 2022
Income (loss) per share before and after dilution, SEK (0.34) (0.07) (8.69) (7.78)
Weighted-average number of ordinary shares outstanding for the period, before
and after dilution
53,672,069 53,259,179 53,672,069 53,022,550
Reserves for translation from foreign operations amounted to (SEK 5.2 million) and SEK 9.3 million which are included in retained earn-ings in equity as of December 31, 2023 and 2022, respectively.
NOTES |
| Calliditas Therapeutics | Year-End Report 2023: January - December 30
Note 9 - Incentive Programs
Board LTIP 2021:
This is a performance-based long-term incentive program for Calliditas Board members. The share awards are subject to perfor-mance-based earnings, which is dependent on the development of Calliditas’ share price from the date of the 2021 Annual General
Meeting to July 1, 2024.
Board LTIP 2022:
This is a performance-based long-term incentive program for Calliditas Board members. The share awards are subject to perfor-mance-based earnings, which is dependent on the development of Calliditas’ share price from the date of the 2022 Annual General
Meeting to July 1, 2025.
Board LTIP 2023:
This is a performance-based long-term incentive program for Calliditas Board members. The share awards are subject to perfor-mance-based earnings, which is dependent on the development of Calliditas’ share price from the date of the 2023 Annual General
Meeting to July 1, 2026.
ESOP Programs
Calliditas implements option programs for employees and key consultants in Calliditas. The options are granted free of charge to
participants of the program. The options have a three-year vesting period calculated from the grant date, provided that, with customary
exceptions, the participants remain as employees of, or continue to provide services to, Calliditas. Once the options are vested, they can
be exercised within a one-year period. Each vested option entitles the holder to acquire one share in Calliditas at a predetermined price.
The price per share is to be equivalent to 115% of the weighted average price that the company’s shares were traded for on Nasdaq
Stockholm during the ten trading days preceding the grant date. The options have, at the time of each issue, been valued according to
the Black-Scholes valuation model.
December 31, 2023 December 31, 2022
Options
Outstanding
Share Awards
Outstanding
Total
Outstanding
Options
Outstanding
Share Awards
Outstanding
Total
Outstanding
Incentive Programs
Board LTIP 2020 - - - - 29,928 29,928
Board LTIP 2021 - 22,882 22,882 - 24,244 24,244
Board LTIP 2022 - 37,136 37,136 - 40,706 40,706
Board LTIP 2023 - 40,957 40,957 - - -
ESOP 2020 1,364,730 - 1,364,730 1,371,666 - 1,371,666
ESOP 2021 1,434,500 - 1,434,500 1,479,500 - 1,479,500
ESOP 2022 1,884,500 - 1,884,500 1,101,000 - 1,101,000
ESOP 2023 1,415,000 - 1,415,000 - - -
Total Outstanding 6,098,730 100,975 6,199,705 3,952,166 94,878 4,047,044
NOTES |
| Calliditas Therapeutics | Year-End Report 2023: January - December 31
Definitions and Reconciliations of Alternative Performance Measures
Definitions of Alternative Performance Measures
Alternative
Key Performance Indicator Definitions Reason for Inclusion
Equity ratio at the end of the period in % The ratio at the end of respective period
is calculated by dividing total shareholders’
equity by total assets.
The equity ratio measures the proportion of
the total assets that are financed by share-holders.
Reconciliations of Alternative Performance Measures
December 31,
(SEK in thousands or otherwise indicated) 2023 2022
Equity ratio at the end of the period in %
Total shareholders' equity at the end of the period 334,806 766,264
Total assets at the end of the period 1,859,245 1,952,973
Equity ratio at the end of the period in % 18% 39%
NOTES |
Calliditas Therapeutics AB (PK) (USOTC:CLTEF)
過去 株価チャート
から 6 2024 まで 7 2024
Calliditas Therapeutics AB (PK) (USOTC:CLTEF)
過去 株価チャート
から 7 2023 まで 7 2024