Ascendis Pharma A/S (Nasdaq: ASND) today announced financial
results for the fourth quarter and full year ended December 31,
2023 and provided a business update.
“In 2023, we streamlined Ascendis, including our structure,
processes, and operating expense allocation, and at the same time
we believe we remain on track to achieve Vision 3x3,” said Jan
Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
“SKYTROFA is the leading growth hormone product in value in the
U.S., the launch of YORVIPATH® in our Europe Direct and
International Markets segments is underway beginning with Germany
and Austria, and our clinical program for TransCon CNP is
advancing. Ascendis is a leaner, more efficient organization in
2024, well-positioned to fulfill the strategic goals outlined in
our Vision 2030, including achieving blockbuster status for each of
our three independent Endocrinology Rare Disease products and
expanding our engine for future innovation.”
Select 2023 Highlights & Anticipated 2024
Milestones
- TransCon hGH: (lonapegsomatropin, approved as SKYTROFA in the
U.S. and EU)
- Fourth quarter SKYTROFA revenue
totaled €64 million, a 37% sequential increase. Full year 2023
SKYTROFA revenue totaled €179 million compared to €36 million the
year prior.
|
Q4-2022 |
Q1-2023 |
Q2-2023 |
Q3-2023 |
Q4-2023 |
SKYTROFA revenue (millions) |
€17 |
€32 |
€36 |
€47 |
€64 |
|
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|
|
|
|
-
- Full year 2024 SKYTROFA revenue expected to be €320 million to
€340 million (based on average 2023 exchange rates).
- Plan to submit a supplemental Biologics License Application to
FDA for adult growth hormone deficiency (GHD), in the second
quarter of 2024.
- Topline results from Phase 2 trial in Turner syndrome expected
in the fourth quarter of 2024.
- TransCon
PTH:(palopegteriparatide, approved as YORVIPATH in the EU)
- Launch of TransCon PTH underway with
full commercial availability in Germany and Austria.
- In the U.S., Prescription Drug User
Fee Act (PDUFA) date of May 14, 2024; if approved, U.S. commercial
launch planned in the third quarter of 2024.
- TransCon
CNP:(navepegritide)
- First patient enrolled in Phase 2
reACHin Trial in infants with achondroplasia (age 0-2 years).
Estimated total enrollment of 72 patients.
- Topline data from pivotal ApproaCH
Trial expected in the fourth quarter of 2024, and plan to submit a
New Drug Application to FDA for children with achondroplasia (age
2-11 years) in the same quarter.
- Topline data from Week 26 of the
COACH Trial (TransCon hGH/TransCon CNP combination) expected in
children with achondroplasia (age 2-11 years) in the fourth quarter
of 2024.
- During the fourth quarter of 2024,
plan to submit an Investigational New Drug application or similar
in adults with achondroplasia.
- TransCon IL-2
β/γ:(onvapegleukin alfa)
- During the fourth quarter of 2024,
plan to provide a clinical update from the Phase 2 portion of
indication-specific, dose expansion cohorts in the IL Believe
trial.
- TransCon TLR7/8
Agonist:
- During the fourth quarter of 2024,
plan to provide a clinical update from the Phase 2 portion of
indication-specific, dose expansion cohorts in the transcendIT-101
trial.
- Ophthalmology
- In January 2024, announced the
formation and launch of Eyconis, Inc., a separate company created
to develop, manufacture, and commercialize TransCon ophthalmology
assets globally.
- Financial Update and
Outlook Based on Current Plans
- Ended 2023 with cash, cash
equivalents, and marketable securities totaling €399 million.
- Full year 2024 SKYTROFA revenue
expected to be €320 million to €340 million (based on average 2023
exchange rates).
- Expect total operating expenses
(SG&A and R&D) of approximately €600 million for 2024.
- Expect to be operating cash flow
breakeven on a quarterly basis by the end of 2024.
Fourth Quarter and Full Year 2023 Financial
ResultsTotal revenue for the fourth quarter of 2023 was
€137.7 million compared to €22.9 million during the same period for
2022. The increase was primarily attributable to the $70.0 million
upfront payment from Teijin, reported in license revenue and higher
SKYTROFA revenue of €64.2 million compared to €17.1 million in the
same period last year. Total revenue for 2023 was €266.7 million
compared to €51.2 million in 2022. The increase was primarily
attributable to higher SKYTROFA revenue of €178.7 million in 2023
compared to €35.7 million last year and the $70.0 million upfront
payment from Teijin, reported in license revenue.
Research and development (R&D) costs for the fourth quarter
were €90.9 million compared to €108.6 million during the same
period in 2022. The decrease was tied to lower external development
costs for TransCon hGH and Oncology programs. R&D costs for
2023 were €413.5 million compared to €379.6 million in 2022. The
higher R&D costs in 2023 reflect an increase in TransCon CNP,
Oncology and Ophthalmology program development activities and an
increase in employee related costs attributable to organizational
growth, partially offset by lower TransCon hGH program development
costs.
Selling, general, and administrative (SG&A) expenses for the
fourth quarter were €64.0 million compared to €56.6 million during
the same period in 2022. This increase was primarily due to higher
employee related expenses attributable to organizational growth.
SG&A expenses for 2023 were €264.4 million compared to €221.2
million in 2022. Higher SG&A expenses were primarily due to
organizational growth including commercial personnel to support
existing SKYTROFA sales in the U.S. and Germany, and in preparation
for future product launches.
Total operating expenses for the fourth quarter were €154.9
million compared to €165.2 million during the same period in 2022.
Total operating expenses for 2023 were €677.9 million compared to
€600.9 million in 2022.
Net finance expenses were €41.6 million in the fourth quarter
compared to €46.7 million in the same period in 2022. Net finance
expenses were €0.2 million in 2023 compared to a net finance income
of €1.7 million in 2022.
For the fourth quarter of 2023, Ascendis Pharma reported a net
loss of €86.9 million, or €1.54 per share (basic and diluted)
compared to a net loss of €207.4 million, or €3.71 per share (basic
and diluted) for the same period in 2022. For the full year 2023,
Ascendis Pharma reported a net loss of €481.4 million, or €8.55 per
share (basic and diluted) compared to a net loss of €583.2 million,
or €10.40 per share (basic and diluted) in 2022.
As of December 31, 2023, Ascendis Pharma had cash, cash
equivalents, and marketable securities totaling €399.4 million
compared to €742.9 million as of December 31, 2022. As of December
31, 2023, Ascendis Pharma had 57,707,439 ordinary shares
outstanding, including 1,093,054 ordinary shares represented by
ADSs held by the company.
Conference Call and Webcast InformationAscendis
Pharma will also host a conference call and webcast today at 4:30
p.m. Eastern Time (ET) to discuss 2023 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 the Ascendis Pharma website shortly
after conclusion of the event for 30 days.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform to build a
leading, fully integrated biopharma company focused on making a
meaningful difference in patients’ lives. Guided by its core values
of patients, science and passion, Ascendis uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Germany and the United States. Please visit
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) TransCon PTH’s
PDUFA date of May 14, 2024, (ii) the timing of topline results from
the ApproaCH Trial, (iii) Ascendis’ ability to achieve Vision 3x3,
(iv) Ascendis’ ability to fulfill its strategic goals outlined in
Vision 2030, including achieving blockbuster status for each of its
three independent Endocrinology Rare Disease products and expanding
its engine for future innovation, (v) Ascendis’ expectations
regarding full year 2024 revenue for SKYTROFA, (vi) Ascendis’ plan
to submit a Biologics License Application for SKYTROFA for adult
GHD in the second quarter of 2024, (vii) the timing of topline
results from the Phase 2 trial in Turner syndrome, (viii) the
launch of TransCon PTH in the U.S., if approved, (ix) the estimated
total enrollment in the Phase 2 reACHin Trial, (x) the timing of
topline data from the ApproaCH Trial, (xi) Ascendis’ plan to submit
a New Drug Application for TransCon CNP for children with
achondroplasia, (xii) the timing of topline data from Week 26 of
the COACH Trial, (xiii) Ascendis’ plan to submit an Investigational
New Drug application or similar for TransCon CNP in adults with
achondroplasia, (xiv) Ascendis’ plan to provide a clinical update
from the Phase 2 portion of indication-specific, dose expansion
cohorts of the IL Believe trial, (xv) Ascendis’ plan to provide a
clinical update from the Phase 2 portion of indication-specific,
dose expansion cohorts in the transcendIT-101 trial during the
fourth quarter of 2024, (xvi) Eyconis, Inc.’s ability to develop,
manufacture, and commercialize TransCon ophthalmology assets
globally, (xvii) Ascendis’ expectations regarding its total
operating expenses for 2024, (xviii) Ascendis’ expectation that it
will be operating cash flow breakeven on a quarterly basis by the
end of 2024, (xix) Ascendis’ ability to apply its TransCon
technology platform to build a leading, fully integrated biopharma
company, and (xx) 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,
distributors and service providers for Ascendis’ products and
product candidates; unforeseen safety or efficacy results in
Ascendis’ development programs or on-market products; unforeseen
expenses related to commercialization of any approved Ascendis
products; unforeseen expenses related to Ascendis’ development
programs; unforeseen selling, general and administrative expenses,
other research and development expenses and Ascendis’ business
generally; delays in the development of its programs related to
manufacturing, regulatory requirements, speed of patient
recruitment or other unforeseen delays; 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. 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 February 7, 2024 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, SKYTROFA®, and YORVIPATH® are trademarks owned by
the Ascendis Pharma group. © February 2024 Ascendis Pharma A/S.
Investor Contacts:Tim LeeAscendis Pharma+1 (650)
374-6343tle@ascendispharma.comir@ascendispharma.com |
Media Contact:Melinda BakerAscendis Pharma+1 (650)
709-8875media@ascendispharma.com |
Patti BankICR Westwicke+1 (415)
513-1284patti.bank@westwicke.com |
|
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) |
|
|
|
|
|
|
|
|
|
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|
Three Months ended December 31, |
|
Twelve Months ended December 31, |
|
|
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|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
Revenue |
137,703 |
|
|
22,895 |
|
|
266,718 |
|
|
51,174 |
|
Cost of sales |
19,457 |
|
|
5,111 |
|
|
44,395 |
|
|
12,137 |
|
Gross profit |
118,246 |
|
|
17,784 |
|
|
222,323 |
|
|
39,037 |
|
|
|
|
|
|
|
|
|
Research and development costs |
90,881 |
|
|
108,618 |
|
|
413,454 |
|
|
379,624 |
|
Selling, general and administrative expenses |
63,975 |
|
|
56,553 |
|
|
264,410 |
|
|
221,227 |
|
Operating profit / (loss) |
(36,610 |
) |
|
(147,387 |
) |
|
(455,541 |
) |
|
(561,814 |
) |
|
|
|
|
|
|
|
|
Share of profit / (loss) of associate |
(2,924 |
) |
|
(7,962 |
) |
|
(18,395 |
) |
|
(17,697 |
) |
Finance income |
22,727 |
|
|
3,305 |
|
|
43,857 |
|
|
52,181 |
|
Finance expenses |
64,280 |
|
|
50,027 |
|
|
44,065 |
|
|
50,487 |
|
Profit / (loss) before tax |
(81,087 |
) |
|
(202,071 |
) |
|
(474,144 |
) |
|
(577,817 |
) |
|
|
|
|
|
|
|
|
Income taxes (expenses) |
(5,791 |
) |
|
(5,348 |
) |
|
(7,303 |
) |
|
(5,377 |
) |
Net profit / (loss) for the period |
(86,878 |
) |
|
(207,419 |
) |
|
(481,447 |
) |
|
(583,194 |
) |
|
|
|
|
|
|
|
|
Attributable to owners of the Company |
(86,878 |
) |
|
(207,419 |
) |
|
(481,447 |
) |
|
(583,194 |
) |
|
|
|
|
|
|
|
|
Basic and diluted earnings / (loss) per share |
€ (1.54 |
) |
|
€ (3.71 |
) |
|
€ (8.55 |
) |
|
€ (10.40 |
) |
|
|
|
|
|
|
|
|
Number of shares used for
calculation (basic and diluted) |
56,560,368 |
|
|
55,941,261 |
|
|
56,287,060 |
|
|
56,071,793 |
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|
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|
Net profit / (loss) for the period |
(86,878 |
) |
|
(207,419 |
) |
|
(481,447 |
) |
|
(583,194 |
) |
Other comprehensive income / (loss) |
|
|
|
|
|
|
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
(1,498 |
) |
|
2,211 |
|
|
(2,731 |
) |
|
(327 |
) |
Other comprehensive income / (loss) for the period, net of
tax |
(1,498 |
) |
|
2,211 |
|
|
(2,731 |
) |
|
(327 |
) |
|
|
|
|
|
|
|
|
Total comprehensive income / (loss) for the period, net of
tax |
(88,376 |
) |
|
(205,208 |
) |
|
(484,178 |
) |
|
(583,521 |
) |
|
|
|
|
|
|
|
|
Attributable to owners of the Company |
(88,376 |
) |
|
(205,208 |
) |
|
(484,178 |
) |
|
(583,521 |
) |
|
|
|
|
|
|
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|
Ascendis Pharma
A/S |
|
|
|
|
Consolidated
Statements of Financial Position |
|
(In
EUR'000s) |
|
|
|
December 31, |
|
December 31, |
2023 |
|
2022 |
Assets |
|
|
|
|
Non-current assets |
|
|
|
|
Intangible assets |
4,419 |
|
|
4,828 |
|
Property, plant and equipment |
110,634 |
|
|
129,095 |
|
Investment in associate |
5,686 |
|
|
22,932 |
|
Other receivables |
2,127 |
|
|
1,920 |
|
Marketable securities |
- |
|
|
7,492 |
|
|
122,866 |
|
|
166,267 |
|
|
|
|
|
|
Current assets |
|
|
|
|
Inventories |
208,931 |
|
|
130,673 |
|
Trade receivables |
35,874 |
|
|
11,910 |
|
Income tax receivables |
802 |
|
|
883 |
|
Other receivables |
19,097 |
|
|
12,833 |
|
Prepayments |
38,578 |
|
|
31,717 |
|
Marketable securities |
7,275 |
|
|
290,688 |
|
Cash and cash equivalents |
392,164 |
|
|
444,767 |
|
|
702,721 |
|
|
923,471 |
|
|
|
|
|
|
Total assets |
825,587 |
|
|
1,089,738 |
|
|
|
|
|
|
Equity and liabilities |
|
|
|
|
Equity |
|
|
|
|
Share capital |
7,749 |
|
|
7,675 |
|
Distributable equity |
(153,446 |
) |
|
255,673 |
|
Total equity |
(145,697 |
) |
|
263,348 |
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Borrowings |
534,246 |
|
|
387,556 |
|
Lease liabilities |
84,619 |
|
|
95,400 |
|
Derivative liabilities |
143,296 |
|
|
157,950 |
|
Contract liabilities |
5,949 |
|
|
14,213 |
|
Deferred tax liabilities |
5,830 |
|
|
- |
|
|
773,940 |
|
|
655,119 |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
Borrowings |
11,226 |
|
|
11,630 |
|
Lease liabilities |
14,174 |
|
|
13,791 |
|
Contract liabilities |
1,184 |
|
|
- |
|
Trade payables and accrued expenses |
94,566 |
|
|
101,032 |
|
Other liabilities |
41,176 |
|
|
31,989 |
|
Income tax payables |
2,299 |
|
|
5,490 |
|
Provisions |
32,719 |
|
|
7,339 |
|
|
197,344 |
|
|
171,271 |
|
|
|
|
|
|
Total liabilities |
971,284 |
|
|
826,390 |
|
|
|
|
|
|
Total equity and liabilities |
825,587 |
|
|
1,089,738 |
|
|
|
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Ascendis Pharma AS (NASDAQ:ASND)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Ascendis Pharma AS (NASDAQ:ASND)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024