Ascendis Pharma A/S (Nasdaq: ASND) today announced financial
results for the full year ended December 31, 2022 and provided a
business update.
“Our unique TransCon technology platform and algorithm for
product innovation enables us to address major unmet medical needs
with a diverse, growing pipeline of highly differentiated product
candidates,” said Jan Mikkelsen, Ascendis Pharma’s President and
Chief Executive Officer. “With our demonstrated ability to take a
product from concept through approval and launch, we will continue
to focus on building long term value for patients and other
stakeholders, establishing Ascendis Pharma as a leading
sustainable, profitable biopharma company.”
Select Highlights & Anticipated 2023
Milestones
- TransCon hGH:
- First European SKYTROFA
(lonapegsomatropin) commercial launch in Germany on track for the
third quarter of 2023.
- In the third quarter of 2023, we
anticipate completing enrollment in New InsiGHTS, a four-armed
Phase 2 trial designed to investigate the safety, tolerability, and
efficacy of different dose levels of TransCon hGH in patients with
Turner Syndrome.
- We expect Phase 3 topline results
from foresiGHt in adult growth hormone deficiency in the fourth
quarter of 2023.
- Fourth quarter 2022 SKYTROFA
(lonapegsomatropin-tcgd) U.S. revenue grew to €17.1 million.
- TransCon PTH:
- U.S. FDA Priority Review continues
for use in adult patients with hypoparathyroidism, with a PDUFA
date of April 30, 2023. If approved, U.S. commercial launch
expected by the end of the second quarter of 2023.
- European Commission decision on MAA
anticipated during the fourth quarter of 2023. If approved, first
European country launch expected in early 2024.
- In anticipation of U.S. and EU
approvals, commercial, medical affairs, product supply and other
teams continue launch readiness activities.
- Phase 3 PaTHway Japan trial achieved
its primary objectives; topline results consistent with North
American and EU trials.
- Enrollment opened in January 2023
for U.S. Expanded Access Program.
|
Q1-2022 |
Q2-2022 |
Q3-2022 |
Q4-2022 |
2022 |
SKYTROFA revenue (millions) |
€ |
1.9 |
€ |
4.4 |
€ |
12.3 |
€ |
17.1 |
€ |
35.7 |
|
|
|
|
|
|
|
|
|
|
|
- TransCon CNP:
- Announced positive topline data from
the Phase 2 ACcomplisH Trial, with results in children with
achondroplasia down to 2 years of age; as of February 14, 2023 all
57 patients currently remain in the trial with treatment duration
up to 3 years.
- During the second quarter of 2023,
we expect to complete enrollment in ApproaCH, a global randomized,
double-blind, placebo-controlled Phase 2b trial in children ages
2–11 years with achondroplasia. The trial targets enrollment of ~80
patients.
- During the third quarter of 2023, we
plan to submit an IND or similar in children under the age of two
years with achondroplasia.
- TransCon TLR7/8 Agonist:
- Reported topline data and
recommended Phase 2 dose from the dose escalation portion of the
Phase 1/2 transcendIT-101 Trial. Early signs of clinical activity
were observed in patients receiving TransCon TLR7/8 Agonist as
monotherapy or in combination with pembrolizumab.
- Enrollment in the dose expansion
phase of transcendIT-101 continues, with a focus on investigating
TransCon TLR7/8 Agonist in combination with pembrolizumab in four
different cancer types.
- TransCon IL-2 β/γ:
- The Phase 1/2 IL-βelieγe Trial
evaluating TransCon IL-2 β/γ monotherapy in patients with locally
advanced or metastatic solid tumors continues to enroll patients.
Results from monotherapy dose escalation are expected during the
first quarter of 2023. Dose escalation combination therapy results
expected during the third quarter of 2023.
- Preparing to initiate
βelieγe-IT-201, a randomized Phase 2 trial of TransCon IL-2 β/γ and
TLR7/8 combination therapies, in the second quarter of 2023.
- TransCon RBZ:
- Ophthalmology selected as the third
therapeutic area; TransCon RBZ (ranibizumab) selected as the first
investigational pipeline candidate, designed for higher efficacy
with 6-month dosing intervals.
- Ended the fourth quarter of 2022
with cash, cash equivalents, and marketable securities totaling
€742.9 million.
Full-Year 2022 Financial Results
Total revenue for 2022 was €51.2 million compared to €7.8
million in 2021. Revenue for 2022 include SKYTROFA U.S. revenue,
and license, clinical supply and services provided to third
parties, primarily VISEN Pharmaceuticals. Revenue in 2022 benefited
from a full-year contribution of SKYTROFA U.S. revenue of €35.7
million compared to €0.9 million in 2021.
Research and development (R&D) costs for 2022 were €379.6
million compared to €295.9 million in 2021. The higher R&D
costs in 2022 reflect a one-time reversal of pre-launch inventories
in 2021, following the U.S. FDA approval of SKYTROFA in August
2021. In addition, higher R&D costs in 2022 reflect
manufacturing of pre-launch inventories for TransCon PTH and an
increase in employee and other costs attributable to organizational
growth.
Selling, general, and administrative (SG&A) expenses for
2022 were €221.2 million compared to €160.2 million in 2021. Higher
SG&A expenses were primarily due to an increase in commercial
and administrative personnel following the launch of SKYTROFA in
the U.S. and preparation for future product launches.
Our share of net loss of associate was €17.7 million in 2022,
compared to a net gain of €12.0 million in 2021. For 2021, the net
profit of associate included a non-cash gain of €42.3 million as a
result of a financing round in VISEN.
Net finance income was €1.7 million in 2022 compared to a net
finance income of €55.8 million in 2021.
For the full year 2022, Ascendis Pharma reported a net loss of
€583.2 million, or €10.40 per share (basic and diluted) compared to
a net loss of €383.6 million, or €7.00 per share (basic and
diluted) for the same period in 2021.
As of December 31, 2022, Ascendis Pharma had cash, cash
equivalents, and marketable securities totaling €742.9 million
compared to €789.6 million as of December 31, 2021. As of December
31, 2022, Ascendis Pharma had 57,152,295 ordinary shares
outstanding.
Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at
4:30 pm Eastern Time (ET) to discuss its full year 2022 financial
results.
Those who would like to participate may access the live webcast
here, or register in advance for the teleconference here. The link
to the live webcast will also be available on the Investors &
News section of the Ascendis Pharma website at
https://investors.ascendispharma.com. A replay of the webcast will
be available on this section of our website shortly after
conclusion of the event for 30 days.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon platform to build a leading, fully
integrated, global biopharma company focused on making a meaningful
difference in patients’ lives. Guided by its core values of
patients, science and passion, the company uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark, and has
additional facilities in Heidelberg, Berlin and Munich, Germany;
Palo Alto and Redwood City, California; and Princeton, New Jersey.
Please visit www.ascendispharma.com to learn more.
Forward-Looking Statements This press release
contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of
historical facts, included in this press release regarding
Ascendis’ future operations, plans and objectives of management are
forward-looking statements. Examples of such statements include,
but are not limited to, statements relating to (i) Ascendis’ PDUFA
date of April 30, 2023 with respect to the FDA’s Priority Review of
TransCon PTH, (ii) the timing of the European MAA decision for
TransCon PTH; (iii) the expected launch of TransCon hGH in Germany;
(iv) the timing and announcement of Phase 3 data in new adult GHD
indication; (v) the ability of Ascendis’ TransCon platform and
algorithm for product innovation to address major unmet medical
needs with a diverse, growing pipeline of highly differentiated
product candidates; (vi) the timing and announcement of top-line
results from the foresiGHt Trial and the Phase 1/2 IL-βelieγe
Trial; (vii) the timing of completion of patient enrollment in the
New InsiGHTS Trial, Phase 2b ApproaCH Trial, dose expansion phase
of the Phase 1/2 transcendIT-101 Trial and the Phase 1/2 IL-βelieγe
Trial; (viii) the expected commercial launch of TransCon PTH in the
U.S. and EU; (ix) the expected submission of an IND for TransCon
CNP; (x) Ascendis’ intent to initiate the βelieγe -IT-201 trial of
TransCon IL-2β/γ and TLR7/8 combination therapy, (xi) TransCon
RBZ’s ability to reduce the intravitreal treatment burden for
patients; (xii) Ascendis’ ability to apply its TransCon platform to
build a leading, fully integrated global biopharma company, and
(xiii) Ascendis’ use of its TransCon technologies to create new and
potentially best-in-class therapies. Ascendis may not actually
achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in the forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Actual results or events could differ
materially from the plans, intentions, expectations and projections
disclosed in the forward-looking statements. Various important
factors could cause actual results or events to differ materially
from the forward-looking statements that Ascendis makes, including
the following: dependence on third party manufacturers and
distributors to supply Ascendis’ products and product candidates,
if approved, for commercial sales in the U.S. and other study drug
for clinical studies; unforeseen safety or efficacy results in its
oncology and ophthalmology programs, TransCon hGH, TransCon PTH and
TransCon CNP or other development programs; unforeseen expenses
related to commercialization of Ascendis’ products and product
candidates, if approved, in the U.S. and EU, the co-pay program and
the further development of Ascendis’ products and product
candidates; expenses related to the development and potential
commercialization of its oncology and ophthalmology programs,
TransCon hGH, TransCon PTH and TransCon CNP or other programs;
unforeseen selling, general and administrative expenses, other
research and development expenses and Ascendis’ business generally;
delays in the development of its oncology and ophthalmology
programs, TransCon hGH, TransCon PTH and TransCon CNP or other
programs related to manufacturing, regulatory requirements, speed
of patient recruitment or other unforeseen delays; dependence on
third party manufacturers to supply study drug for planned clinical
studies; Ascendis’ ability to obtain additional funding, if needed,
to support its business activities; the impact of international
economic, political, legal, compliance, social and business
factors, including inflation, and the effects on its business from
the worldwide COVID-19 pandemic and the ongoing conflict in the
region surrounding Ukraine and Russia. For a further description of
the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to Ascendis’ business in general, see
Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities
and Exchange Commission (SEC) on March 2, 2022 and Ascendis’ other
future reports filed with, or submitted to, the SEC.
Forward-looking statements do not reflect the potential impact of
any future licensing, collaborations, acquisitions, mergers,
dispositions, joint ventures, or investments that Ascendis may
enter into or make. Ascendis does not assume any obligation to
update any forward-looking statements, except as required by
law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company
logo, TransCon, and Skytrofa® are trademarks owned by the Ascendis
Pharma Group. © February 2023 Ascendis Pharma A/S.
FINANCIAL TABLES FOLLOW
Ascendis Pharma A/S |
|
|
|
Consolidated Statements of Profit or Loss and Comprehensive
Income / (loss) |
|
|
(In
EUR'000s, except share and per share data) |
|
|
|
|
|
|
|
|
Year ended December 31, |
|
|
|
|
|
2022 |
|
2021 |
|
|
|
|
Revenue |
51,174 |
|
|
7,778 |
|
Cost of
sales |
12,137 |
|
|
3,523 |
|
Gross profit |
39,037 |
|
|
4,255 |
|
|
|
|
|
Research and
development costs |
379,624 |
|
|
295,867 |
|
Selling,
general and administrative expenses |
221,227 |
|
|
160,180 |
|
Operating profit / (loss) |
(561,814 |
) |
|
(451,792 |
) |
|
|
|
|
Share of
profit / (loss) of associate |
(17,697 |
) |
|
12,041 |
|
Finance
income |
52,181 |
|
|
59,718 |
|
Finance
expenses |
50,487 |
|
|
3,911 |
|
Profit / (loss) before tax |
(577,817 |
) |
|
(383,944 |
) |
|
|
|
|
Tax on
profit / (loss) for the year |
(5,377 |
) |
|
367 |
|
Net
profit / (loss) for the year |
(583,194 |
) |
|
(383,577 |
) |
|
|
|
|
Attributable
to owners of the Company |
(583,194 |
) |
|
(383,577 |
) |
|
|
|
|
Basic and
diluted earnings / (loss) per share |
€ (10.40) |
|
€ (7.00) |
|
|
|
|
Number of
shares used for calculation (basic and diluted) |
56,071,793 |
|
|
54,771,763 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
profit / (loss) for the year |
(583,194 |
) |
|
(383,577 |
) |
Other comprehensive income / (loss) |
|
|
|
Items that
may be reclassified subsequently to profit or loss: |
|
|
|
Exchange
differences on translating foreign operations |
(327 |
) |
|
3,855 |
|
Other comprehensive income / (loss) for the year, net of
tax |
(327 |
) |
|
3,855 |
|
|
|
|
|
Total comprehensive income / (loss) for the year, net of
tax |
(583,521 |
) |
|
(379,722 |
) |
|
|
|
|
Attributable
to owners of the Company |
(583,521 |
) |
|
(379,722 |
) |
|
|
|
|
Ascendis Pharma A/S |
|
|
|
Consolidated Statements of Financial Position |
|
|
|
(In
EUR'000s) |
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
2022 |
|
2021 |
Assets |
|
|
|
Non-current assets |
|
|
|
Intangible
assets |
4,828 |
|
5,272 |
Property,
plant and equipment |
129,095 |
|
126,049 |
Investment
in associate |
22,932 |
|
38,345 |
Other
receivables |
1,920 |
|
1,808 |
Marketable
securities |
7,492 |
|
107,561 |
|
166,267 |
|
279,035 |
|
|
|
|
Current assets |
|
|
|
Inventories |
130,673 |
|
75,405 |
Trade
receivables |
11,910 |
|
2,200 |
Income tax
receivable |
883 |
|
893 |
Other
receivables |
12,833 |
|
20,093 |
Prepayments |
31,717 |
|
25,231 |
Marketable
securities |
290,688 |
|
235,797 |
Cash and
cash equivalents |
444,767 |
|
446,267 |
|
923,471 |
|
805,886 |
|
|
|
|
Total assets |
1,089,738 |
|
1,084,921 |
|
|
|
|
Equity and liabilities |
|
|
|
Equity |
|
|
|
Share
capital |
7,675 |
|
7,646 |
Distributable equity |
255,673 |
|
875,989 |
Total equity |
263,348 |
|
883,635 |
|
|
|
|
Non-current liabilities |
|
|
|
Borrowings |
482,956 |
|
97,966 |
Derivative
liabilities |
157,950 |
|
- |
Contract
liabilities |
14,213 |
|
2,964 |
|
655,119 |
|
100,930 |
|
|
|
|
Current liabilities |
|
|
|
Borrowings |
25,421 |
|
6,995 |
Contract
liabilities |
- |
|
2,601 |
Trade
payables and accrued expenses |
101,032 |
|
59,417 |
Other
liabilities |
31,989 |
|
29,952 |
Income tax
payables |
5,490 |
|
198 |
Provisions |
7,339 |
|
1,193 |
|
171,271 |
|
100,356 |
|
|
|
|
Total liabilities |
826,390 |
|
201,286 |
|
|
|
|
Total equity and liabilities |
1,089,738 |
|
1,084,921 |
Investor Contacts: |
Media
Contact: |
Tim Lee |
Melinda Baker |
Ascendis Pharma |
Ascendis Pharma |
+1 (650) 374-6343 |
+1 (650) 709-8875 |
tle@ascendispharma.com |
media@ascendispharma.com |
ir@ascendispharma.com |
|
|
|
Patti Bank |
|
ICR Westwicke |
|
+1 (415) 513-1284 |
|
patti.bank@westwicke.com |
|
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