Interim Report - January-September 2021
November 18 2021 - 1:00AM
Interim Report - January-September 2021
STOCKHOLM –
18 November
2021.
Karolinska Development AB (Nasdaq Stockholm: KDEV) today
publishes its Interim
Report -
January-September
2021.
The full report is available on the Company's
website.
“The portfolio companies’ progress and the
positive value development of our holdings increases the potential
for securing additional financial resources to support Karolinska
Development’s development going forward. The latest example of our
ability to contribute to value creation is the divestment of
Forendo Pharma to the global pharmaceutical company Organon in a
deal that could result in up to USD 945 million in proceeds for
Forendo Pharma's shareholders.”, says Viktor Drvota, CEO,
Karolinska Development.
Significant events during the
third quarter
- Karolinska
Development announced that the company has sold its entire holding
in the listed portfolio company Lipidor AB. In total, the
transaction covers 0.95 percent of all outstanding shares in
Lipidor and brings in net approximately SEK 4 million in cash to
Karolinska Development (July 2021).
- The portfolio
company Promimic has received a shared 501(k) clearance from the
U.S. Food and Drug Administration (FDA) with the orthopedic company
Oncos Surgical. The market clearance concerns the implant product
BioGrip® Modular Porous Collars, developed by Onkos Surgical, which
has been coated with HAnano Surface in order to treat implant
loosening in orthopedic oncology and complex revision surgery (July
2021).
- The portfolio
company Umecrine Cognition has carried out a directed new share
issue of SEK 35.1 million to broaden the ownership base ahead of a
planned IPO and to finance the continued clinical development of
the company’s drug candidate golexanolone. At the same time,
Karolinska Development has chosen to convert loans totalling SEK
66.9 million into shares in Umecrine Cognition at the same
subscription price as in the new share issue (July 2021).
- The portfolio
company Modus Therapeutics has completed an oversubscribed issue
(113% subscription rate), providing the company SEK 30 million
after transaction costs. The newly raised capital will primarily be
used to finance the continued clinical development of the company's
drug candidate sevuparin for sepsis and septic shock. As the next
step in the company’s development, a successful listing of the
company's share on Nasdaq First North in Stockholm has been
completed with the 22nd of July as the first day of trading (July
2021).
- The portfolio
company Aprea Therapeutics has reported positive results from a
Phase 2 trial evaluating its drug candidate eprenetapopt with
azacitidine for post-transplant maintenance therapy in patients
with TP53 mutant myelodysplastic syndromes (MDS) and acute myeloid
leukemia (AML). The relapse free survival at 1-year post-transplant
was 58% and overall survival was 79% (July 2021).
- The US Food and
Drug Administration (FDA) has issued a clinical hold for Aprea
Therapeutics clinical program evaluating eprenetapopt with
acalabrutinib or venetoclax and rituximab in lymphoid malignancies.
The issue means there will be a pause in the patient enrollment
until the agency reverses the decision. Aprea Therapeutics intends
to work in close dialogue with the FDA to clarify and address the
agency's concerns in order to resume activity in the clinical trial
program as soon as possible (August 2021).
- The portfolio
company OssDsign AB has launched OssDsign Catalyst in the U.S. The
product is a synthetic bone graft that stimulates the formation of
healthy bone tissue in spinal fusion surgeries. The launch
constitutes an important step in the company’s strategy to
establish itself on the bone graft market in the largest geographic
market for medical device innovations (August 2021).
Significant post-period events
- The portfolio
company OssDsign has included the first patient to the clinical
trial TOP FUSION which aims to evaluate the long-term safety and
efficacy of the synthetic bone graft OssDsign Catalyst in patients
undergoing spinal fusion surgery (September 2021).
- The portfolio
company OssDsign has received an expanded marketing authorization
from the U.S. Food and Drug Administration (FDA) for the company's
patient-specific cranial implant product OssDsign Cranial PSI. The
approval underlines that OssDsign's patented calcium phosphate
composition has osteoconductive properties inducing resorption and
formation of new bone tissue (October 2021).
- The portfolio
company Umecrine Cognition has entered a collaboration with
Professor Trevor G Smart and his research group at University
College London. The collaboration will involve molecular analysis
and behavioral studies of Umecrine Cognition's most advanced drug
candidate, golexanolone (October 2021).
- The portfolio
company AnaCardio has strengthened its organization in preparation
for the initiation of a phase 1b/2a study of its drug candidate
AC01 in patients with heart failure. Anacardio has recently
recruited Patrik Strömberg as its new CEO. He holds a PhD in
biochemistry from Karolinska Institutet, an MBA from the Department
of Business Administration at Stockholm University and has many
years of experience in drug development and business development
from leading positions within AstraZeneca and Sobi (October
2021).
- The portfolio
company Dilafor, a drug development company focusing on the
development of tafoxiparin for obstetric indications, has enrolled
the first patient in a clinical Phase 2a study with tafoxiparin in
pregnant women diagnosed with preeclampsia (October 2021).
- The portfolio
company Umecrine Cognition has presented new scientific results
showing that the innate neurosteroid allopregnanolone plays an
important role in the development of cognitive symptoms observed in
patients with primary biliary cholangitis (PBC). Since Umecrine
Cognition’s drug candidate golexanolone could potentially impact
allopregnanolone the company has, based on the novel clinical
results and other supportive data, initiated preparations for a
Phase 2 clinical study in PBC (November 2021).
- The portfolio
company Modus Therapeutics has received approval from the
regulatory authorities in the Netherlands to carry out a clinical
Phase 1b-study with sevuparin, a potential new treatment of
sepsis/septic shock (November 2021).
- Karolinska
Development announces that the global pharmaceutical company
Organon is acquiring its portfolio company Forendo Pharma. Forendo
Pharma's shareholders will receive an initial payment of USD 75
million (approximate SEK 652 million) and are entitled to
additional future payments totalling USD 870 million (approximate
SEK 7,560 million) upon the achievement of certain development,
registration and commercial milestones pertaining to Forendo
Pharma's drug candidates. The total purchase price, if all
milestones are met, amounts to USD 945 million. Karolinska
Development estimates the risk-adjusted net present value (rNPV) of
future cash flows, including the initial payment, from the
transaction at SEK 114 million, with a positive effect on net
profit of SEK 70 million and a consequential increase in the
portfolio company's fair value of SEK 70 million in the third
quarter 2021. The completion of the transaction is subject to
review by competition authorities and other customary conditions.
The transaction is expected to close in December 2021 (November
2021).
Financial update
- The net
profit/loss for the third quarter was SEK -1.2 million (SEK -169.4
million in the third quarter of 2020). Earnings per share totalled
SEK -0.01 (SEK -1.0 in the third quarter of 2020). Net profit for
the period January – September 2021 amounted to SEK 190.3 (-293.4)
million.
- The result of
the Change in fair value of shares in portfolio companies for the
third quarter amounted to SEK 27.5 million (SEK -173.9 in the third
quarter of 2020). The result is largely due to a combination of
increased fair value of Forendo Pharma with SEK 70 million and a
downturn in share price of in aggregate SEK 15 million in the
listed holdings Modus Therapeutics and OssDsign. The fair value was
also affected negatively by a decrease of the value of the holding
in Umecrine Cognition because of the effect from the directed new
share issue conducted in July 2021. The result of the Change in
fair value of shares in portfolio companies for the period January
– September 2021 amounted to SEK 240.0 (-289.2) million.
- The total fair
value of the portfolio was SEK 1,440.6 million at the end of
September 2021, corresponding to a increase of SEK 43.1 million
from SEK 1,397.5 million at the end of the previous quarter. The
net portfolio fair value at that time was SEK 1,075.5 million,
corresponding to a increase of SEK 44.7 million from SEK 1,030.8
million at the end of the previous quarter.
- Net sales
totalled SEK 0.5 million during the third quarter of 2021 (SEK 0.4
million during the third quarter of 2020). Net sales for the period
January – September 2021 totalled SEK 1.7 (2.1) million.
- Karolinska
Development invested a total of SEK 21.1 million in portfolio
companies during the third quarter. Third quarter investments in
portfolio companies by Karolinska Development and other specialised
life sciences investors totalled SEK 106.1 million.
- Cash and cash
equivalents increased by SEK 24.5 million during the third quarter,
totalling SEK 45.3 million on 30 September 2021. During the third
quarter, Karolinska Development utilized a credit facility of SEK
42.5 million.
- The Parent
Company equity totalled SEK 990.6 (714.4) million on 30 September
2021
The Interim Report for Karolinska Development AB for the period
January-September 2021 is available as a PDF at
www.karolinskadevelopment.com.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development ABPhone: +46 73 982
52 02, e-mail: viktor.drvota@karolinskadevelopment.com
Per Aniansson, CFO, Karolinska Development
AB Phone:
+46 70 866 04 29, e-mail:
per.aniansson@karolinskadevelopment.com
TO THE EDITORS
About Karolinska Development
AB
Karolinska Development AB (Nasdaq Stockholm:
KDEV) is a Nordic life sciences investment company. The company
focuses on identifying breakthrough medical innovations in the
Nordic region that are developed by entrepreneurs and leadership
teams. The Company invests in the creation and growth of companies
that advance these assets into commercial products that are
designed to make a difference to patients' lives while providing an
attractive return on investment to shareholders.
Karolinska Development has access to world-class
medical innovations at the Karolinska Institutet and other leading
universities and research institutes in the Nordic region. The
Company aims to build companies around scientists who are leaders
in their fields, supported by experienced management teams and
advisers, and co-funded by specialist international investors, to
provide the greatest chance of success.
Karolinska Development has established a
portfolio of ten companies targeting opportunities in innovative
treatment for life-threatening or serious debilitating
diseases.
The Company is led by an entrepreneurial team of
investment professionals with a proven track record as company
builders and with access to a strong global network.
For more information, please visit
www.karolinskadevelopment.com
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