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: January 8, 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 ¨
INFORMATION CONTAINED IN THIS REPORT ON FORM
6-K
Enclosed hereto are copies of announcements published by Calliditas
Therapeutics AB on January 7, 2024 and January 8, 2024.
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: January 8, 2024 |
By: |
/s/ Fredrik Johansson |
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Fredrik Johansson
Chief Financial Officer |
Exhibit 99.1
Stockholm, Sweden |
January 7, 2024 |
Calliditas Therapeutics appoints Maria Törnsén
as President North America
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq
Stockholm: CALTX) (“Calliditas”), a commercial biopharma company focused on rare diseases today announced that Maria Törnsén
has been appointed to the position of President North America. Ms Törnsén will be responsible for all US based operations
and will report to the CEO.
Maria Törnsén has broad commercial leadership
experience having spent more than 20 years in the biopharma industry in senior commercial roles. Most recently Ms Törnsén
held the position of Chief Commercial Officer at Passage Bio, prior to which she was SVP General Manager US at Sarepta Therapeutics. Prior
to joining Sarepta she served as VP Global Therapeutic Area Head at Sanofi Genzyme and held several senior commercial roles at Shire including
VP Head of US Sales. Ms Törnsén will replace Mr Andrew Udell, who has held the position since 2020.
“We are pleased to welcome Ms Törnsén
to the executive management team as President of our US operations. She brings invaluable experience from building commercial organisations,
driving growth and profitability in the area of rare diseases, which will be critical as we target the next step in our development.”
said CEO Renée Aguiar- Lucander. “I also want to thank Mr Udell for his valuable contribution to the build-up of the US organisation
and its early commercial success.”
“I am delighted to join Calliditas at this exciting time
in the company’s history, with the recent full FDA approval of TARPEYO® and an innovative late-stage pipeline in rare diseases.
I look forward to working with the Calliditas team to continue advancing the TARPEYO® launch and develop our capabilities to support
further growth.” said Maria Törnsén.
Calliditas received full FDA approval of TARPEYO®(budesonide)
delayed release capsules, a targeted treatment to reduce the loss of kidney function in patients with primary IgA nephropathy (IgAN) at
risk of disease progression on December 20, 2023; the product has been granted conditional approval in Europe and China and is being commercialized
by partners under the brand names of Kinpeygo and Nefecon, respectively. Calliditas is targeting top line read out of several Phase 2
clinical trials with setanaxib, its lead product candidate from its proprietary and novel NOX platform, in 2024.
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 was sent for publication, through the agency
of the contact persons set out above, on January 7, 2024 at 5:00 p.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.
Important Safety Information |
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Contraindications: TARPEYO
is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions,
including anaphylaxis, have occurred with other budesonide formulations.
Warnings and Precautions
Hypercorticism and adrenal axis suppression: When
corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce
the response of the hypothalamus- pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other
stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids,
monitor for signs of adrenal axis suppression.
Patients with moderate to severe hepatic impairment (Child-Pugh
Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic
exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or
symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B).
Risks of immunosuppression: Patients who are on drugs that suppress
the immune system are more susceptible to infection than healthy individuals. Chickenpox and measles, for example, can have a more serious
or even fatal course in susceptible patients or patients on immunosuppressive doses of corticosteroids. Avoid corticosteroid therapy
in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, systemic viral, or parasitic infections, or
ocular herpes simplex. Avoid exposure to active, easily-transmitted infections (e.g., chicken pox, measles). Corticosteroid therapy may
decrease the immune response to some vaccines.
Other corticosteroid effects: TARPEYO is a systemically
available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes
mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition
where corticosteroids may have unwanted effects.
Adverse reactions: In clinical studies, the
most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral
edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%),
weight
increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia
(6%), and white blood cell count increased (6%).
Drug interactions: Budesonide is a substrate for
CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and
cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase
the systemic exposure to budesonide.
Use in specific populations |
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Pregnancy: The available data from published
case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk
of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with
IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism.
Please see Full Prescribing
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 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
Stockholm,Sweden | January
8, 2024 |
Calliditas Therapeutics
provides business update ahead of JP Morgan conference
Calliditas Therapeutics
AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), a commercial biopharma company focused on rare diseases today
provided a business update for the fourth quarter of 2023 and certain preliminary, unaudited key financial information for the fourth
quarter and full year 2023, as follows:
· | Strong
Q4 preliminary product revenue growth with net TARPEYO revenues of $31 – 33m for the
quarter, representing significant growth over Q3. |
· | Preliminary
Net TARPEYO revenues of $100 – 102m for 2023, representing over 170% year over year
growth compared to 2022. |
· | Preliminary
Total revenues reaching $110 – 113m for 2023, as a result of milestone payments and
royalty income from the Nefecon franchise outside the US. |
· | Record
quarter in terms of enrollments with 555 new TARPEYO prescriptions in the 4th
quarter. |
The information above reflects
our preliminary estimates with respect to such results based on currently available information. We have provided ranges, rather than
specific amounts, for the preliminary results described above primarily because our financial closing procedures are not yet complete
and, as a result, our final results may vary from the preliminary estimates.
“We are very pleased
with the preliminary outcome of the 2023 fiscal year, generating product sales in excess of $100 million in our second year of commercialisation.
This is a very strong result and we are very excited about 2024 based on the recent full approval of TARPEYO in the US, strengthened
product protection and the record growth seen in enrollments in Q4. This result, in combination with our successful debt refinancing
and strengthening our US leadership team, puts us in an optimal position to drive growth and profitability in 2024 and build a high growth,
durable franchise in the rare disease space.” said CEO Renée Aguiar-Lucander.
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 persons set out above, on January 8, 2024 at 8.15 am CET.
The above unaudited, estimated
results for the quarter and year ended December 31, 2023 are preliminary financial information, remain subject to completion, and were
prepared by management based upon estimates, a number of assumptions and currently available information, and are subject to revision
based upon, among other things, quarter-end closing procedures and/or adjustments, the completion of our financial statements and other
operational procedures. Our actual results could be materially different from this preliminary financial information, which should not
be regarded as a representation by us as to our actual results for the quarter and year ended December 31, 2023. In addition, our independent
registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this preliminary financial
information and does not express an opinion or any other form of assurance with respect to this preliminary financial information. During
the course of the preparation of our financial statements and related notes as of and for the quarter and year ended
December 31, 2023, we may identify
items that would require us to make material adjustments to this preliminary financial information.
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, 2023 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.
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