Ascendis Pharma A/S (Nasdaq: ASND) today announced financial
results for the second quarter ended June 30, 2024, and provided a
business update.
“The recent FDA approval of YORVIPATH demonstrates why our
unrelenting focus on helping patients suffering from
hypoparathyroidism and other serious diseases with considerable
unmet need is so important for Ascendis,” said Jan Mikkelsen,
Ascendis Pharma’s President and Chief Executive Officer. “Already,
two out of our three Endocrine Rare Disease TransCon product
candidates have been approved by the FDA and European Commission.
Our first, SKYTROFA, has achieved U.S. market value leadership,
and, we believe, now with broader market access, remains well
positioned to reach blockbuster status in the U.S. alone. Looking
forward, we are preparing for our second U.S. launch with YORVIPATH
and are on track to report pivotal data in the coming weeks for our
third TransCon product candidate, TransCon CNP.”
Select Highlights & Anticipated 2024
Milestones
- TransCon
hGH:(lonapegsomatropin, marketed as SKYTROFA)
- SKYTROFA revenue for
the second quarter of 2024 totaled €26.2 million, a 27%
year-over-year decrease compared to €35.9 million during the same
period in 2023. 134% year-over-year volume growth was offset by the
cost associated with broader market access for SKYTROFA which also
resulted in a negative adjustment to prior period sales deductions
of €27.1 million, where €19.5 million and €7.6 million were
attributable to the three months ended March 31, 2024, and periods
prior to January 1, 2024, respectively.
- SKYTROFA revenue for
the first half of 2024 totaled €91.2 million, a 35% year-over-year
increase compared to €67.4 million during the same period of 2023.
159% year-over-year volume growth was offset by the cost associated
with broader market access for SKYTROFA which also resulted in a
negative adjustment to prior period sales deductions of €7.6
million, which were attributable to periods prior to January 1,
2024.
- On track to submit a
supplemental Biologics License Application to the FDA for adult
growth hormone deficiency in the third quarter of 2024.
- Topline results from
Phase 2 New InsiGHTS Trial in Turner syndrome expected in the
fourth quarter of 2024.
- TransCon PTH:(palopegteriparatide,
marketed as YORVIPATH)
- Received U.S. FDA
approval for TransCon PTH, under the brand name YORVIPATH, for the
treatment of hypoparathyroidism in adults.
- Completing
manufacturing of commercial product for the U.S. market and
anticipate initial supply will be available in the first quarter of
2025. The Company is in dialogue with the FDA about
commercialization of existing manufactured product, which if
agreed, could be introduced in the U.S. in the fourth quarter of
2024.
- Second quarter
YORVIPATH revenue totaled €5.2 million, reflecting the first full
quarter of commercial launch in Germany and Austria as well initial
revenue in International Markets. Initial revenue in France
expected starting in the fourth quarter of 2024.
- TransCon CNP(navepegritide)
- Topline data from
pivotal ApproaCH Trial expected in the coming weeks, and, if
successful, plan to submit a New Drug Application to FDA for
children with achondroplasia (age 2-11 years) in the first quarter
of 2025.
- Plan to complete
enrollment in the combination TransCon hGH and TransCon CNP COACH
trial of children with achondroplasia (ages 2-11 years) during the
third quarter of 2024; topline Week 26 data expected in the second
quarter of 2025.
- Expect to initiate
teACH, a Phase 2 trial in adolescents with achondroplasia, in the
fourth quarter of 2024.
- Oncology Programs
- Presented new and updated results
from the ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β⁄γ in
a poster presentation at ASCO 2024. As of the April 16, 2024, data
cutoff, 40% of efficacy-evaluable patients (2 out of 5) in the
initial cohort of patients with anti-PD-1 refractory melanoma
treated with TransCon IL-2 β⁄γ in combination with TransCon
TLR7/8 Agonist exhibited confirmed clinical responses with no new
safety signals.
- Initial results from
the Phase 2 dose expansion cohort of the IL-Believe Trial of
TransCon IL-2 β⁄γ in combination with chemotherapy in
platinum-resistant ovarian cancer (PROC) will be presented later
this month at the European Society for Medical Oncology (ESMO) 2024
Congress in Barcelona, Spain.
- Financial Update and Outlook Based
on Current Plans
- As of June 30, 2024,
Ascendis Pharma had cash, cash equivalents, and marketable
securities totaling €259 million, compared to €399 million as of
December 31, 2023.
- Full year 2024
SKYTROFA revenue expected to be €220 million to €240 million.
- Expect total
operating expenses (SG&A and R&D) to be approximately €600
million for 2024.
- Pending launch
timing of YORVIPATH in the U.S., expect to be operating cash flow
breakeven on a quarterly basis in 2024 or 2025
- Subsequent to the
quarter end, entered into a $150 million capped synthetic royalty
funding agreement with Royalty Pharma relating to net sales of
YORVIPATH in the United States. More information on this funding
can be found in a separate press release issued today and available
here on the Investors & News section of the Ascendis Pharma
website.
Second Quarter 2024 Financial ResultsTotal
revenue for the second quarter of 2024 was €36.0 million, compared
to €47.4 million during the same period for 2023. Results in the
quarter were primarily impacted by a negative adjustment to prior
periods’ estimates and assumptions for sales deductions of €27.1
million, where €19.5 million and €7.6 million were attributable to
the three months ended March 31, 2024, and periods prior to January
1, 2024, respectively. This was partially offset by increased
demand for SKYTROFA in the U.S. and revenue contribution from
YORVIPATH. In addition, non-product revenue was €4.6 million in the
second quarter of 2024, compared to €11.5 million during the same
period for 2023.
Total Revenue (In EUR'000s) |
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
Revenue from external customers |
|
|
|
|
|
|
|
|
Commercial
sale of products |
31,389 |
|
35,895 |
|
97,888 |
|
67,446 |
|
Licenses |
869 |
|
589 |
|
25,639 |
|
1,203 |
|
Other |
3,740 |
|
10,909 |
|
8,365 |
|
12,333 |
|
Total revenue from external customers |
35,998 |
|
47,393 |
|
131,892 |
|
80,982 |
|
Research and development (R&D) costs for the second quarter
of 2024 were €83.5 million, compared to €105.0 million during the
same period in 2023. The decline was largely tied to lower external
development costs for TransCon TLR 7/8 Agonist and lower costs for
TransCon PTH, as well as lower employee costs as a result of the
Eyconis spin-off.
Selling, general, and administrative (SG&A) expenses for the
second quarter of 2024 were €74.3 million, compared to €70.3
million during the same period in 2023. The increase was primarily
due to higher employee costs, including the impact from commercial
expansion.
Total operating expenses for the second quarter of 2024 were
€157.8 million compared to €175.3 million during the same period in
2023.
Net finance income for the second quarter of 2024 was €29.4
million compared to a net finance income of €26.4 million during
the same period in 2023.
For the second quarter of 2024, Ascendis Pharma reported a net
loss of €109.4 million, or €1.91 per share (basic and diluted)
compared to a net loss of €121.4 million, or €2.16 per share (basic
and diluted) for the same period in 2023.
As of June 30, 2024, Ascendis Pharma had cash, cash equivalents,
and marketable securities totaling €258.7 million compared to
€399.4 million as of December 31, 2023. As of June 30, 2024,
Ascendis Pharma had 58,231,484 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 second 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) the timing of topline results from the ApproaCH Trial, (ii)
Ascendis’ expectations regarding full year 2024 SKYTROFA revenue,
(iii) Ascendis’ expectations regarding SKYTROFA’s potential to
reach blockbuster status, (iv) Ascendis’ plan to submit a
supplemental Biologics License Application for SKYTROFA for adult
growth hormone deficiency in the third quarter of 2024, (v) the
timing of topline results from the Phase 2 trial of TransCon hGH in
Turner syndrome, (vi) Ascendis’ plan to submit a New Drug
Application for TransCon CNP for children with achondroplasia,
(vii) Ascendis’ expectations regarding completing manufacturing of
YORVIPATH commercial product for the U.S. market and the timing of
initial supply, (viii) dialogue with FDA regarding
commercialization of existing YORVIPATH manufactured product and,
if agreed, the potential timing of introduction, (ix) Ascendis’
expectations regarding initial revenue in France from YORVIPATH,
(x) Ascendis’ plan to complete enrollment in the COACH Trial, (xi)
the timing of topline Week 26 data from the COACH Trial, (xii) the
timing of initiating the teACH Phase 2 trial in adolescents, (xiii)
Ascendis’ plan to present initial results from the Phase 2 dose
expansion cohort of the IL-Believe Trial, (xiv) Ascendis’
expectations regarding its total operating expenses for 2024, (xv)
Ascendis’ expectation to be operating cash flow breakeven on a
quarterly basis in 2024 or 2025, (xvi) Ascendis’ ability to apply
its TransCon technology platform to build a leading, fully
integrated biopharma company, and (xvii) 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. © September 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/S Consolidated Statements of Profit or
Loss and Comprehensive Income / (Loss) (In EUR'000s, except share
and per share data) |
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Consolidated Statement of Profit or Loss |
|
|
|
|
|
|
|
Revenue |
|
35,998 |
|
|
|
47,393 |
|
|
|
131,892 |
|
|
|
80,982 |
|
Cost of
sales |
|
11,465 |
|
|
|
12,929 |
|
|
|
19,034 |
|
|
|
17,551 |
|
Gross profit |
|
24,533 |
|
|
|
34,464 |
|
|
|
112,858 |
|
|
|
63,431 |
|
Research and
development costs |
|
83,478 |
|
|
|
105,021 |
|
|
|
154,165 |
|
|
|
211,134 |
|
Selling,
general and administrative expenses |
|
74,312 |
|
|
|
70,281 |
|
|
|
141,095 |
|
|
|
136,820 |
|
Operating profit/(loss) |
|
(133,257 |
) |
|
|
(140,838 |
) |
|
|
(182,402 |
) |
|
|
(284,523 |
) |
Share of
profit/(loss) of associate |
|
(5,322 |
) |
|
|
(7,451 |
) |
|
|
(11,118 |
) |
|
|
(8,677 |
) |
Finance
income |
|
49,052 |
|
|
|
35,761 |
|
|
|
14,395 |
|
|
|
80,374 |
|
Finance
expenses |
|
19,624 |
|
|
|
9,334 |
|
|
|
58,553 |
|
|
|
18,652 |
|
Profit/(loss) before tax |
|
(109,151 |
) |
|
|
(121,862 |
) |
|
|
(237,678 |
) |
|
|
(231,478 |
) |
Income
taxes/(expenses) |
|
(229 |
) |
|
|
429 |
|
|
|
(2,737 |
) |
|
|
(868 |
) |
Net
profit/(loss) for the period |
|
(109,380 |
) |
|
|
(121,433 |
) |
|
|
(240,415 |
) |
|
|
(232,346 |
) |
Attributable
to owners of the Company |
|
(109,380 |
) |
|
|
(121,433 |
) |
|
|
(240,415 |
) |
|
|
(232,346 |
) |
Basic and
diluted earnings/(loss) per share |
€ |
(1.91 |
) |
|
€ |
(2.16 |
) |
|
€ |
(4.21 |
) |
|
€ |
(4.14 |
) |
Number of
shares used for calculation (basic and diluted) |
|
57,345,613 |
|
|
|
56,218,257 |
|
|
|
57,114,435 |
|
|
|
56,155,441 |
|
|
|
|
|
|
|
|
|
|
(EUR’000) |
|
|
Consolidated Statement of Comprehensive Income or
(Loss) |
|
|
|
|
|
|
|
Net
profit/(loss) for the period |
|
(109,380 |
) |
|
|
(121,433 |
) |
|
|
(240,415 |
) |
|
|
(232,346 |
) |
Items that
may be reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
Exchange
differences on translating foreign operations |
|
15 |
|
|
|
(1,016 |
) |
|
|
78 |
|
|
|
(1,803 |
) |
Other comprehensive income/(loss) for the period, net of
tax |
|
15 |
|
|
|
(1,016 |
) |
|
|
78 |
|
|
|
(1,803 |
) |
Total comprehensive income/(loss) for the period, net of
tax |
|
(109,365 |
) |
|
|
(122,449 |
) |
|
|
(240,337 |
) |
|
|
(234,149 |
) |
Attributable
to owners of the Company |
|
(109,365 |
) |
|
|
(122,449 |
) |
|
|
(240,337 |
) |
|
|
(234,149 |
) |
Ascendis Pharma A/S Consolidated Statements of Financial
Position (In EUR'000s) |
June 30, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
Non-current assets |
|
|
|
Intangible assets |
4,186 |
|
|
4,419 |
|
Property,
plant and equipment |
104,041 |
|
|
110,634 |
|
Investment
in associates |
20,564 |
|
|
5,686 |
|
Other
receivables |
2,186 |
|
|
2,127 |
|
|
130,977 |
|
|
122,866 |
|
Current assets |
|
|
|
Inventories |
251,199 |
|
|
208,931 |
|
Trade
receivables |
49,163 |
|
|
35,874 |
|
Income tax
receivables |
1,841 |
|
|
802 |
|
Other
receivables |
29,679 |
|
|
19,097 |
|
Prepayments |
36,743 |
|
|
38,578 |
|
Marketable
securities |
— |
|
|
7,275 |
|
Cash and
cash equivalents |
258,696 |
|
|
392,164 |
|
|
627,321 |
|
|
702,721 |
|
Total assets |
758,298 |
|
|
825,587 |
|
|
|
|
|
Equity and liabilities |
|
|
|
Equity |
|
|
|
Share
capital |
7,819 |
|
|
7,749 |
|
Distributable equity |
(328,952 |
) |
|
(153,446 |
) |
Total equity |
(321,133 |
) |
|
(145,697 |
) |
|
|
|
|
Non-current liabilities |
|
|
|
Borrowings |
219,052 |
|
|
222,996 |
|
Contract
liabilities |
5,000 |
|
|
5,949 |
|
Deferred tax
liabilities |
7,644 |
|
|
5,830 |
|
|
231,696 |
|
|
234,775 |
|
Current liabilities |
|
|
|
Convertible notes, matures in April 2028 |
|
|
|
Borrowings |
432,190 |
|
|
407,095 |
|
Derivative
liabilities |
159,059 |
|
|
143,296 |
|
|
591,249 |
|
|
550,391 |
|
Other current liabilities |
|
|
|
Borrowings |
21,397 |
|
|
14,174 |
|
Contract
liabilities |
1,293 |
|
|
1,184 |
|
Trade
payables and accrued expenses |
99,527 |
|
|
94,566 |
|
Other
liabilities |
26,411 |
|
|
41,176 |
|
Income tax
payables |
1,090 |
|
|
2,299 |
|
Provisions |
106,768 |
|
|
32,719 |
|
|
256,486 |
|
|
186,118 |
|
|
847,735 |
|
|
736,509 |
|
Total liabilities |
1,079,431 |
|
|
971,284 |
|
Total equity and liabilities |
758,298 |
|
|
825,587 |
|
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