Ascendis Pharma A/S (Nasdaq: ASND) today announced financial
results for the first quarter ended March 31, 2024, and provided a
business update.
“With SKYTROFA revenue more than doubling in the U.S. compared
to the first quarter of 2023, and our successful initial launch of
YORVIPATH in Germany and Austria, we believe Ascendis is on the
path to achieving sustainable growth and operating cash flow
breakeven on a quarterly basis by the end of 2024,” said Jan
Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
“Our achievements this quarter give me further confidence that all
elements are in place to deliver three independent Endocrinology
Rare Disease blockbuster products and a strong pipeline in larger
therapeutic areas such as Oncology, Ophthalmology, and Metabolic
Diseases as outlined in Vision 2030.”
Select Highlights & Anticipated 2024
Milestones
- TransCon
hGH:(lonapegsomatropin, approved as SKYTROFA in the U.S., EU,
European Economic Area (EEA) countries, and Great Britain)
- First quarter 2024
SKYTROFA revenue totaled €65 million, a 106% year over year
increase with a steady quarter to quarter increase in treated
patients.
- 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 third 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, EEA
countries, and Great Britain)
- Commercial rollout
of YORVIPATH continues in Germany and Austria with an estimated 55
doctors writing prescriptions and ~100 patients receiving
commercial product as of March 31. First quarter YORVIPATH revenue
totaled €1.5 million reflecting first two months of delivery to
patients.
- 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.
- Granted marketing
authorization for the treatment of adults with chronic
hypoparathyroidism and orphan drug status in Great Britain.
- TransCon
CNP:(navepegritide)
- 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.
- Expect to initiate
and complete enrollment in the combination TransCon hGH and
TransCon CNP COACH trial of children with achondroplasia (ages
2-11) during the second quarter of 2024; topline Week 26 data
expected in the fourth quarter of 2024.
- Oncology Programs
- New data from the
ongoing Phase 1/2 IL-Believe Trial has been accepted for a poster
presentation at the American Society for Clinical Oncology (ASCO)
May 31-June 4. The presentation will provide initial data from the
combination of TransCon IL-2 β/γ and TransCon TLR7/8 Agonists in
patients with melanoma who have progressed on anti-PD1
therapy.
- During the fourth
quarter of 2024, plan to provide a clinical update from the Phase 2
indication-specific, dose expansion cohorts from our TransCon IL-2
β/γ and TransCon TLR7/8 Agonist clinical trials.
- Financial Update and
Outlook Based on Current Plans
- As of March 31,
2024, Ascendis Pharma had cash, cash equivalents, and marketable
securities totaling €320 million compared to €399 million as of
December 31, 2023.
- 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.
First Quarter 2024 Financial ResultsTotal
revenue for the first quarter of 2024 was €95.9 million compared to
€33.6 million during the same period for 2023. The increase was
primarily attributable to higher SKYTROFA revenue of €65.0 million
compared to €31.6 million in the same period last year and non-cash
license revenue of €24.8 million related to the license agreement
with Eyconis in January 2024.
Total Revenue (In EUR'000s) |
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
Revenue from external customers |
|
|
|
|
|
|
|
Commercial sale of products |
|
66,499 |
|
|
|
31,551 |
|
Licenses |
|
24,770 |
|
|
|
614 |
|
Other |
|
4,625 |
|
|
|
1,424 |
|
Total revenue from external customers |
|
95,894 |
|
|
|
33,589 |
|
|
|
|
|
|
|
|
|
Research and development (R&D) costs for the first quarter
of 2024 were €70.7 million compared to €106.1 million during the
same period in 2023. The 33% decline was largely tied to lower
external development costs for TransCon hGH, TransCon PTH
(including a reversal of prior period write-downs of pre-launch
inventories) and Oncology programs, partially offset by an increase
in TransCon CNP costs.
Selling, general, and administrative (SG&A) expenses for the
first quarter of 2024 were €66.8 million compared to €66.5 million
during the same period in 2023. Higher employee costs, including
the impact from commercial expansion, partly offset by lower
external pre-launch and administrative expenses.
Total operating expenses for the first quarter of 2024 were
€137.5 million compared to €172.7 million during the same period in
2023.
Net finance expenses for the first quarter of 2024 were €73.6
million compared to a net finance income of €35.3 million during
the same period in 2023.
For the first quarter of 2024, Ascendis Pharma reported a net
loss of €131.0 million, or €2.30 per share (basic and diluted)
compared to a net loss of €110.9 million, or €1.98 per share (basic
and diluted) for the same period in 2023.
As of March 31, 2024, Ascendis Pharma had cash, cash
equivalents, and marketable securities totaling €320.2 million
compared to €399.4 million as of December 31, 2023. As of March 31,
2024, Ascendis Pharma had 58,224,419 ordinary shares outstanding,
including 881,730 ordinary shares represented by ADSs held by the
company.
Conference Call and Webcast InformationAscendis
Pharma will host a conference call and webcast today at 4:30 pm
Eastern Time (ET) to discuss its first quarter 2024 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 Europe 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 commercial launch of TransCon
PTH in the U.S., if approved, (iii) the timing of topline results
from the ApproaCH Trial, (iv) Ascendis’ expectations regarding full
year 2024 revenue for SKYTROFA, (v) Ascendis’ ability to fulfill
its strategic goals to deliver three independent Endocrinology Rare
Disease blockbuster products and a strong pipeline in larger
therapeutic areas such as Oncology, Ophthalmology, and Metabolic
Diseases, (vi) Ascendis’ plan to submit a supplemental Biologics
License Application for SKYTROFA for adult GHD in the third quarter
of 2024, (vii) the timing of topline results from the Phase 2 trial
in Turner syndrome, (viii) the timing of topline data from the
ApproaCH Trial, (ix) Ascendis’ plan to submit a New Drug
Application for TransCon CNP for children with achondroplasia, (x)
Ascendis’ ability to initiate and complete enrollment in the COACH
Trial, (xi) the timing of topline data from Week 26 of the COACH
Trial, (xii) Ascendis’ plan to present initial data from the Phase
1/2 IL-Believe Trial, (xiii) Ascendis’ plan to provide a clinical
update from the Phase 2 portion of indication-specific, dose
expansion cohorts of the IL Believe trial, (xiv) Ascendis’
expectations regarding its total operating expenses for 2024, (xv)
Ascendis’ expectation that it will be operating cash flow breakeven
on a quarterly basis by the end of 2024, (xvi) Ascendis’ belief
that it is on a path to achieving sustainable growth and that all
elements are in place to deliver three independent Endocrinology
Rare Disease blockbuster products, (xvii) Ascendis’ ability to
apply its TransCon technology platform to build a leading, fully
integrated biopharma company, and (xviii) 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. © May 2024 Ascendis Pharma A/S.
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 |
|
|
|
FINANCIAL TABLES FOLLOW
Ascendis Pharma A/SConsolidated Statements of Profit or
Loss and Comprehensive Income / (Loss)(In EUR'000s, except share
and per share data) |
Three Months Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Consolidated Statement of Profit or Loss |
|
|
|
Revenue |
|
95,894 |
|
|
|
33,589 |
|
Cost of sales |
|
7,569 |
|
|
|
4,621 |
|
Gross profit |
|
88,325 |
|
|
|
28,968 |
|
Research and development costs |
|
70,687 |
|
|
|
106,114 |
|
Selling, general and administrative expenses |
|
66,783 |
|
|
|
66,539 |
|
Operating profit/(loss) |
|
(49,145 |
) |
|
|
(143,685 |
) |
Share of profit/(loss) of associate |
|
(5,796 |
) |
|
|
(1,227 |
) |
Finance income |
|
3,575 |
|
|
|
45,135 |
|
Finance expenses |
|
77,161 |
|
|
|
9,840 |
|
Profit/(loss) before tax |
|
(128,527 |
) |
|
|
(109,617 |
) |
Income taxes/(expenses) |
|
(2,508 |
) |
|
|
(1,297 |
) |
Net profit/(loss) for the period |
|
(131,035 |
) |
|
|
(110,914 |
) |
Attributable to owners of the Company |
|
(131,035 |
) |
|
|
(110,914 |
) |
Basic and diluted earnings/(loss) per share |
€ |
(2.30 |
) |
|
€ |
(1.98 |
) |
Number of shares used for calculation (basic and diluted) |
|
56,883,257 |
|
|
|
56,091,927 |
|
|
|
|
|
|
|
Consolidated Statement of Comprehensive Income or
(Loss) |
|
|
|
Net profit/(loss) for the period |
|
(131,035 |
) |
|
|
(110,914 |
) |
Items that may be reclassified subsequently to profit or loss: |
|
|
|
Exchange differences on translating foreign operations |
|
63 |
|
|
|
(787 |
) |
Other comprehensive income/(loss) for the period, net of
tax |
|
63 |
|
|
|
(787 |
) |
Total comprehensive income/(loss) for the period, net of
tax |
|
(130,972 |
) |
|
|
(111,701 |
) |
Attributable to owners of the Company |
|
(130,972 |
) |
|
|
(111,701 |
) |
Ascendis Pharma A/SConsolidated Statements of Financial
Position(In EUR'000s) |
March 31, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
Non-current assets |
|
|
|
Intangible assets |
|
4,301 |
|
|
|
4,419 |
|
Property, plant and equipment |
|
107,164 |
|
|
|
110,634 |
|
Investment in associates |
|
24,797 |
|
|
|
5,686 |
|
Other receivables |
|
2,129 |
|
|
|
2,127 |
|
|
|
138,391 |
|
|
|
122,866 |
|
Current assets |
|
|
|
Inventories |
|
232,681 |
|
|
|
208,931 |
|
Trade receivables |
|
41,092 |
|
|
|
35,874 |
|
Income tax receivables |
|
742 |
|
|
|
802 |
|
Other receivables |
|
26,857 |
|
|
|
19,097 |
|
Prepayments |
|
42,502 |
|
|
|
38,578 |
|
Marketable securities |
|
— |
|
|
|
7,275 |
|
Cash and cash equivalents |
|
320,239 |
|
|
|
392,164 |
|
|
|
664,113 |
|
|
|
702,721 |
|
Total assets |
|
802,504 |
|
|
|
825,587 |
|
|
|
|
|
Equity and liabilities |
|
|
|
Equity |
|
|
|
Share capital |
|
7,818 |
|
|
|
7,749 |
|
Distributable equity |
|
(245,997 |
) |
|
|
(153,446 |
) |
Total equity |
|
(238,179 |
) |
|
|
(145,697 |
) |
|
|
|
|
Non-current liabilities |
|
|
|
Borrowings |
|
229,627 |
|
|
|
222,996 |
|
Contract liabilities |
|
5,000 |
|
|
|
5,949 |
|
Deferred tax liabilities |
|
7,085 |
|
|
|
5,830 |
|
|
|
241,712 |
|
|
|
234,775 |
|
Current liabilities |
|
|
|
Convertible notes, matures in April 2028 |
|
|
|
Borrowings |
|
424,984 |
|
|
|
407,095 |
|
Derivative liabilities |
|
197,291 |
|
|
|
143,296 |
|
|
|
622,275 |
|
|
|
550,391 |
|
Other current liabilities |
|
|
|
Borrowings |
|
14,403 |
|
|
|
14,174 |
|
Contract liabilities |
|
1,183 |
|
|
|
1,184 |
|
Trade payables and accrued expenses |
|
94,526 |
|
|
|
94,566 |
|
Other liabilities |
|
22,698 |
|
|
|
41,176 |
|
Income tax payables |
|
3,336 |
|
|
|
2,299 |
|
Provisions |
|
40,550 |
|
|
|
32,719 |
|
|
|
176,696 |
|
|
|
186,118 |
|
|
|
798,971 |
|
|
|
736,509 |
|
Total liabilities |
|
1,040,683 |
|
|
|
971,284 |
|
Total equity and liabilities |
|
802,504 |
|
|
|
825,587 |
|
|
|
|
|
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