Ascendis Pharma Reports Third Quarter 2023 Financial Results
07 Noviembre 2023 - 3:01PM
Ascendis Pharma A/S (Nasdaq: ASND) today announced financial
results for the third quarter ended September 30, 2023 and provided
business updates.
“This quarter marks an important milestone for Ascendis on our
path to become a leading, sustainable biopharma company, where we
began our journey to extend our SKYTROFA U.S. market value
leadership globally with our first EU product launch in Germany,”
said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive
Officer. “Expected approval in the EU for our second product,
TransCon PTH, this month demonstrates the value of following our
algorithm for product innovation.”
Corporate Highlights
- TransCon hGH (marketed in the U.S.
and EU as SKYTROFA):
- Third quarter 2023 SKYTROFA revenue
totaled €47.0 million, a 31% sequential increase. Increased full
year 2023 SKYTROFA revenue expectations from €165 – €170 million to
€170 – €175 million.
|
Q3-2022 |
Q4-2022 |
Q1-2023 |
Q2-2023 |
Q3-2023 |
SKYTROFA revenue (millions) |
€12.3 |
€17.1 |
€31.6 |
€35.9 |
€47.0 |
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- Announced results from enliGHten,
the Company’s open-label extension trial evaluating the long-term
safety and efficacy of TransCon hGH for children and adolescents
with growth hormone deficiency (GHD), demonstrating the long-term
safety and efficacy of TransCon hGH in patients treated up to six
years, with the majority of children meeting or exceeding average
parental height SDS at time of treatment completion or last
visit.
- Topline results from Phase 3
foresiGHt Trial in adult growth hormone deficiency expected in the
fourth quarter of 2023, potentially opening a new label expansion
opportunity.
- TransCon PTH:
- On September 14, 2023, the European
Medicines Agency’s Committee for Medicinal Products for Human Use
(CHMP) adopted a positive opinion, recommending the approval of
TransCon PTH (palopegteriparatide) as a parathyroid hormone
replacement therapy indicated for the treatment of adults with
chronic hypoparathyroidism. Final European Commission decision is
expected this month. If approved, the first launch is planned in
Germany, leveraging the Company’s existing SKYTROFA commercial
infrastructure, in January 2024.
- In the U.S., expect to resubmit NDA
for TransCon PTH for adults with hypoparathyroidism to the FDA
before mid-November.
- Presented 52-week data from Phase 3
PaTHway Trial demonstrating that skeletal dynamics of patients with
chronic hypoparathyroidism trended toward a new steady state closer
to age-appropriate norms with continued use of TransCon PTH.
Results confirm trends previously reported in the Phase 2 PaTH
Forward Trial.
- As of September 30, 2023, 145 out of
154 participants continue in the open-label extension (OLE)
portions of the Phase 2 PaTH Forward, Phase 3 PaTHway, and PaTHway
Japan trials.
- TransCon CNP:
- Completed enrollment in ApproaCH, a
Phase 3, global randomized, double-blind, placebo-controlled trial
in children ages 2–11 years with achondroplasia. Topline results
are expected in the second half of 2024.
- Filed an Investigational New Drug
(IND) amendment with the FDA to initiate reACHin, a Phase 2,
multicenter, double-blind, randomized, placebo-controlled trial,
designed to evaluate the safety, tolerability, and efficacy of 100
μg/kg of TransCon CNP once-weekly for 52 weeks in infants aged 0 to
< 2 years with achondroplasia.
- One-year follow-up data from
AComplisH OLE expected in the fourth quarter of 2023.
- During the fourth quarter of 2023,
the Company expects to file an IND amendment or similar for COACH,
a combination trial evaluating TransCon CNP and TransCon hGH in
children with achondroplasia. The Company believes that this
combination therapy may provide greater annualized height velocity
than CNP alone, and at the same time, address the comorbidities of
achondroplasia.
- TransCon IL-2 β/γ:
- Reported new data from ongoing Phase
1/2 IL-Believe Trial demonstrating clinical activity of TransCon
IL-2 β/γ as monotherapy or in combination with a checkpoint
inhibitor. Of three small-cell lung cancer patients treated in the
combination portion of the trial who had previously progressed on
checkpoint inhibitors, a partial response (confirmed) and a
complete response (unconfirmed, treatment ongoing) were observed to
date.
- Enrollment continues in the Phase 2
portion in indication-specific cohorts; first patient dosed with
TransCon IL-2 b/g and TransCon TLR7/8 Agonist in combination.
Initial data from indication-specific cohorts expected in the
second half of 2024.
- TransCon TLR7/8 Agonist:
- Enrollment continues in Phase 2
portion of transcendIT-101, a Phase 1/2 trial to evaluate TransCon
TLR7/8 Agonist as monotherapy or in combination with pembrolizumab
in dose escalation and dose expansion. Initial data expected in the
second half of 2024.
- Ended the third quarter of 2023 with cash, cash equivalents,
and marketable securities totaling €455.4 million.
Third Quarter 2023 Financial ResultsTotal
revenue for the third quarter of 2023 was €48.0 million compared to
€15.3 million during the same period in 2022. The increase was
primarily attributable to higher SKYTROFA revenue of €47.0 million
compared to €12.3 million in the same period last year.
Research and development (R&D) costs for the third quarter
were €111.4 million compared to €97.4 million during the same
period in 2022. This increase was primarily due to higher
development costs for the Oncology and Ophthalmology programs,
increasing clinical trial activities for TransCon CNP, and higher
employee-related costs, and was partly offset by lower development
costs for TransCon hGH.
Selling, general, and administrative (SG&A) expenses for the
third quarter were €63.6 million compared to €60.7 million during
the same period in 2022. This increase was primarily due to higher
employee related expenses and other expenses attributable to
organizational growth.
Net finance expenses were €20.4 million in the third quarter
compared to €20.9 million in the same period in 2022.
For the third quarter of 2023, Ascendis Pharma reported a net
loss of €162.2 million, or €2.88 per share (basic and diluted)
compared to a net loss of €169.0 million, or €3.03 per share (basic
and diluted) for the same period in 2022.
As of September 30, 2023, Ascendis Pharma had cash, cash
equivalents, and marketable securities totaling €455.4 million
compared to €742.9 million as of December 31, 2022. As of September
30, 2023, Ascendis Pharma had 57,656,568 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 third quarter 2023
financial results.
To participate in the call, please dial (800) 445-7795
(domestic) or +1 (785) 424-1699 (international), and reference
passcode ASNDQ323. 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 platform technology 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, 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 Germany (Heidelberg and Munich) and the United States
(Palo Alto and Redwood City, California, and Princeton, New
Jersey). 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
the European Commission decision for TransCon PTH and the potential
approval of TransCon PTH in the EU; (ii) Ascendis’ plan to resubmit
an NDA for TransCon PTH before mid-November; (iii) Ascendis’ plans
to launch TransCon PTH, if approved, in Germany in January 2024;
(iv) Ascendis’ expectations regarding the initiation of its
combination trial of TransCon CNP and TransCon hGH; (v) Ascendis’
expectations regarding 2023 SKYTROFA revenues; (vi) Ascendis’
ability to become a leading, sustainable biopharma company; (vii)
Ascendis’ ability to extend its SKYTROFA U.S. market value
leadership globally; (viii) the timing of Topline results from
Phase 3 foresiGHt trial and the potential for a label expansion
opportunity; (ix) the timing of topline results from the ApproaCH
trial; (x) the timing of one-year follow-up data from the OLE
portion of the ACcomplisH trial; (xi) Ascendis’ plan to file an IND
amendment or similar for COACH; (xii) the ability for a combination
therapy of TransCon CNP and TransCon hGH to provide greater
annualized height velocity than CNP alone and address the
comorbidities of achondroplasia; (xiii) the timing of initial data
from indication-specific cohorts in the Phase 2 portion of the
Phase 1/2 IL-Believe Trial; (xiv) the timing of initial data from
the Phase 2 portion of transcendIT-101; (xv) Ascendis’ ability to
apply its TransCon technology platform to build a leading, fully
integrated global biopharma company; and (xvi) 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,
including inflation, the effects on its business from the worldwide
COVID-19 pandemic and ongoing conflicts such as that 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 February 16, 2023 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, and TransCon ® are trademarks owned by the Ascendis Pharma
group. © November 2023 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 |
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Patti Bank |
|
ICR Westwicke |
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+1 (415) 513-1284 |
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patti.bank@westwicke.com |
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FINANCIAL TABLES FOLLOW
Ascendis Pharma A/S |
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Consolidated Statements of Profit or Loss and Comprehensive
Income / (Loss) |
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(In
EUR'000s, except share and per share data) |
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Three Months ended September 30, |
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Nine Months ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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|
Revenue |
48,034 |
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|
15,290 |
|
|
129,016 |
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|
28,278 |
|
Cost of
sales |
7,388 |
|
|
1,693 |
|
|
24,938 |
|
|
7,025 |
|
Gross profit |
40,646 |
|
|
13,597 |
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|
104,078 |
|
|
21,253 |
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|
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|
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Research and
development costs |
111,439 |
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|
97,431 |
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|
322,573 |
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|
271,006 |
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Selling,
general and administrative expenses |
63,614 |
|
|
60,671 |
|
|
200,435 |
|
|
164,675 |
|
Operating profit / (loss) |
(134,407 |
) |
|
(144,505 |
) |
|
(418,930 |
) |
|
(414,428 |
) |
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Share of
profit / (loss) of associate |
(6,794 |
) |
|
(3,696 |
) |
|
(15,471 |
) |
|
(9,736 |
) |
Finance
income |
4,142 |
|
|
20,326 |
|
|
76,985 |
|
|
73,797 |
|
Finance
expenses |
24,519 |
|
|
41,247 |
|
|
35,640 |
|
|
25,381 |
|
Profit / (loss) before tax |
(161,578 |
) |
|
(169,122 |
) |
|
(393,056 |
) |
|
(375,748 |
) |
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|
|
|
|
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Income taxes
(expenses) |
(645 |
) |
|
167 |
|
|
(1,513 |
) |
|
(28 |
) |
Net
profit / (loss) for the period |
(162,223 |
) |
|
(168,955 |
) |
|
(394,569 |
) |
|
(375,776 |
) |
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Attributable
to owners of the Company |
(162,223 |
) |
|
(168,955 |
) |
|
(394,569 |
) |
|
(375,776 |
) |
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Basic and
diluted earnings / (loss) per share |
€ (2.88) |
|
€ (3.03) |
|
€ (7.02) |
|
€ (6.70) |
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Number of
shares used for calculation (basic and diluted) |
56,272,698 |
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|
55,831,561 |
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56,194,956 |
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56,115,782 |
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Net
profit / (loss) for the period |
(162,223 |
) |
|
(168,955 |
) |
|
(394,569 |
) |
|
(375,776 |
) |
Other comprehensive income / (loss) |
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Items that
may be reclassified subsequently to profit or loss: |
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Exchange
differences on translating foreign operations |
571 |
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|
(2,207 |
) |
|
(1,232 |
) |
|
(2,538 |
) |
Other comprehensive income / (loss) for the period, net of
tax |
571 |
|
|
(2,207 |
) |
|
(1,232 |
) |
|
(2,538 |
) |
|
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|
|
|
|
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Total comprehensive income / (loss) for the period, net of
tax |
(161,652 |
) |
|
(171,162 |
) |
|
(395,801 |
) |
|
(378,314 |
) |
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Attributable
to owners of the Company |
(161,652 |
) |
|
(171,162 |
) |
|
(395,801 |
) |
|
(378,314 |
) |
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Ascendis Pharma A/S |
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Consolidated Statements of Financial Position |
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(In
EUR'000s) |
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September
30, |
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December 31, |
2023 |
|
2022 |
Assets |
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Non-current assets |
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Intangible assets |
4,495 |
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|
4,828 |
Property,
plant and equipment |
125,535 |
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|
129,095 |
Investment
in associate |
8,116 |
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|
22,932 |
Other
receivables |
2,142 |
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|
1,920 |
Marketable
securities |
- |
|
|
7,492 |
|
140,288 |
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|
166,267 |
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Current assets |
|
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Inventories |
189,132 |
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|
130,673 |
Trade
receivables |
26,794 |
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|
11,910 |
Income tax
receivables |
1,644 |
|
|
883 |
Other
receivables |
21,595 |
|
|
12,833 |
Prepayments |
38,327 |
|
|
31,717 |
Marketable
securities |
14,165 |
|
|
290,688 |
Cash and
cash equivalents |
441,268 |
|
|
444,767 |
|
732,925 |
|
|
923,471 |
|
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Total assets |
873,213 |
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|
1,089,738 |
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Equity and liabilities |
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Equity |
|
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Share
capital |
7,742 |
|
|
7,675 |
Distributable equity |
(81,175 |
) |
|
255,673 |
Total equity |
(73,433 |
) |
|
263,348 |
|
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Non-current liabilities |
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Borrowings |
549,483 |
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|
387,555 |
Lease
liabilities |
90,103 |
|
|
95,401 |
Derivative
liabilities |
93,353 |
|
|
157,950 |
Contract
liabilities |
949 |
|
|
14,213 |
|
733,888 |
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|
655,119 |
|
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Current liabilities |
|
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Borrowings |
11,824 |
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|
11,630 |
Lease
liabilities |
14,433 |
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|
13,791 |
Contract
liabilities |
4,030 |
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|
- |
Trade
payables and accrued expenses |
121,552 |
|
|
101,032 |
Other
liabilities |
33,660 |
|
|
31,989 |
Income tax
payables |
6,478 |
|
|
5,490 |
Provisions |
20,781 |
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|
7,339 |
|
212,758 |
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|
171,271 |
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Total liabilities |
946,646 |
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|
826,390 |
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|
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Total equity and liabilities |
873,213 |
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|
1,089,738 |
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Ascendis Pharma AS (NASDAQ:ASND)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Ascendis Pharma AS (NASDAQ:ASND)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024