Ascendis Pharma A/S (Nasdaq: ASND) today announced financial
results for the second quarter ended June 30, 2023 and provided
business updates.
“We have built a fully integrated Endocrinology Rare Disease
franchise with a growing commercial reach and are on our way to
achieving our Vision 3x3, including regulatory approval for three
differentiated product candidates by 2025,” said Jan Mikkelsen,
Ascendis Pharma’s President and Chief Executive Officer. “With a
proven U.S. and expanding global commercial infrastructure
positioned to capture the multi-billion-dollar opportunities that
each represents, coupled with an R&D engine for label expansion
and future innovation for new patient populations, Ascendis has
many routes to realize long-term profitability and
sustainability.”
Corporate Highlights
- TransCon hGH (marketed in the U.S.
as SKYTROFA):
- Second quarter 2023 SKYTROFA revenue
totaled €36 million, and the Company is increasing full year 2023
U.S. SKYTROFA revenue expectations from €150 - €160 million to €165
- €170 million.
- Second quarter 2023 SKYTROFA revenue
included a negative adjustment to provision for estimated sales
rebates related to sales from prior periods of €2.1 million as a
result of expanding payer coverage and a negative foreign currency
impact of €0.6 million compared to the first quarter of 2023, due
to a weaker U.S. dollar.
|
Q2-2022 |
Q3-2022 |
Q4-2022 |
Q1-2023 |
Q2-2023 |
SKYTROFA revenue (millions) |
€4.4 |
€12.3 |
€17.1 |
€31.6 |
€35.9 |
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- Based on reported revenues, SKYTROFA
was the leading U.S. growth hormone product in the second quarter,
with a market share of less than 10% of treated U.S. pediatric GHD
patients.
- First commercial launch of SKYTROFA
in the EU expected in September in Germany.
- Received FDA approval of Lonza as a
high-capacity drug substance manufacturing site to support
worldwide demand of SKYTROFA. Expect EU approval in first half of
2024.
- Topline results from Phase 3
foresiGHt Trial in adult growth hormone deficiency investigating
the metabolic impact of TransCon hGH expected in the fourth quarter
of 2023, opening up the first label expansion opportunity.
- TransCon PTH:
- In June 2023, the Company requested
a Type A meeting with FDA and submitted an updated control
strategy. The Company’s Type A meeting was held with FDA in late
August based on the Agency’s availability. Following a constructive
Type A meeting, the Company submitted additional information to FDA
supporting the updated control strategy. Ascendis believes the
materials submitted to FDA combined with the Type A meeting
discussions will position the Company to resubmit the NDA for
TransCon PTH for adults with hypoparathyroidism in October
2023.
- Remain on track for European
Commission decision on Marketing Authorisation Application (MAA)
for TransCon PTH during the fourth quarter of 2023. If approved,
first country launch planned in Germany in early 2024.
- New post hoc analysis showed
TransCon PTH-treated patients demonstrated substantial increases in
estimated glomerular filtration rate (eGFR), indicating improved
kidney function. More information on this analysis can be found in
a separate press release issued today and available here on the
Investors & News section of the Ascendis Pharma website.
- 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.
- The U.S. Expanded Access Program and
German Compassionate Use Program continue to be open for enrollment
of eligible patients.
- TransCon CNP:
- U.S. and EU regulatory agencies have
endorsed ApproaCH, a global randomized, double-blind,
placebo-controlled trial in children ages 2–11 years with
achondroplasia, as a pivotal Phase 3 trial. Enrollment is complete
and topline results are expected in the second half of 2024.
- All 57 patients remain in the OLE
portion of the Phase 2 ACcomplisH Trial, with treatment duration up
to 3 years. One-year follow-up data from OLE expected in the fourth
quarter of 2023.
- TransCon TLR7/8 Agonist:
- Enrollment continues in the Phase 2
portion of transcendIT-101 at the recommended Phase 2 dose (RP2D)
in four indication-specific cohorts. Topline/interim analysis from
Phase 2 dose-expansion cohorts expected in 2024.
- TransCon IL-2 β/γ
- Completed Phase 1 dose escalation in
combination with pembrolizumab in the Phase 1/2 IL-Believe Trial
with a total of 21 patients enrolled. RP2D was determined at 120
µg/kg IV every three weeks. No dose-limiting toxicity, vascular
leak syndrome, or grade 3 or 4 cytokine release syndrome was
observed at any dose level evaluated.
- Enrollment initiated in the Phase 2
portion in indication-specific cohorts, with expected
topline/interim analysis from Phase 2 dose-expansion cohorts
expected in 2024.
- Expanding leadership in long-acting
prodrug technologies with new TransCon technology carrier platform
to unlock large market opportunities where high volume and low-cost
manufacturing is required.
- Proof-of-principle demonstrated for
GLP-1 analogs (semaglutide), with data supporting potential
best-in-class weekly and monthly administration profiles. More
information on the pre-clinical data can be found in a presentation
here on the Investors & News section of the Ascendis Pharma
website.
- Ended the second quarter of 2023
with cash, cash equivalents, and marketable securities totaling
€431.1 million.
- Subsequent to the quarter end,
entered into a $150 million capped synthetic royalty funding
agreement with Royalty Pharma. 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 2023 Financial Results
Total revenue for the second quarter of 2023 was €47.4 million
compared to €6.2 million during the same period in 2022. The
increase was primarily attributable to higher SKYTROFA revenue of
€35.9 million compared to €4.4 million in the same period last
year.
Research and development (R&D) costs for the second quarter
were €105.0 million compared to €90.4 million during the same
period in 2022. This increase was primarily due to higher
development costs for Ascendis Pharma Oncology programs (TransCon
IL-2 β/γ and TransCon TLR7/8 Agonist), 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
second quarter were €70.3 million compared to €56.6 million during
the same period in 2022. This increase was primarily due to higher
external commercial expenses related to SKYTROFA, pre-launch
activities for SKYTROFA outside the U.S., global pre-launch
activities for TransCon PTH, higher employee related expenses, and
an increase in other general and administrative expenses
attributable to organizational growth.
Net finance income was €26.4 million in the second quarter
compared to €61.7 million in the same period in 2022.
For the second quarter of 2023, Ascendis Pharma reported a net
loss of €121.4 million, or €2.16 per share (basic and diluted)
compared to a net loss of €81.3 million, or €1.46 per share (basic
and diluted) for the same period in 2022.
As of June 30, 2023, Ascendis Pharma had cash, cash equivalents,
and marketable securities totaling €431.1 million compared to
€742.9 million as of December 31, 2022. As of June 30, 2023,
Ascendis Pharma had 57,335,496 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 second quarter 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 our 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, 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, Berlin 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 StatementsThis 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’ plan
to resubmit an NDA for TransCon PTH in October 2023; (ii) the
timing and results of the EC decision on the TransCon PTH MAA;
(iii) the timing of topline results of the ApproaCH trial; (iv)
Ascendis’ expectations regarding 2023 SKYTROFA revenues in the
United States; (v) Ascendis’ ability to achieve its Vision 3x3;
(vi) Ascendis’ expectations regarding regulatory approval for three
independent product candidates by 2025; (vii) Ascendis’ ability to
capture the opportunities presented by its product candidates and
realize long-term profitability and sustainability; (viii)
Ascendis’ SKYTROFA revenue expectations; (ix) Ascendis’
expectations regarding the launch of SKYTROFA in Germany; (x)
Ascendis’ expectations regarding EU approval at Lonza for a
high-capacity drug substance manufacturing site; (xi) the timing of
Topline results from Phase 3 foresiGHt trial and the potential for
the first label expansion opportunity; (xii) Ascendis’ expectations
regarding the launch of TransCon PTH in Germany; (xiii) the timing
of topline results from the ApproaCH trial; (xiv) the timing of
one-year follow-up data from the OLE portion of the Phase 2
ACcomplisH trials; (xv) the timing of topline/interim analysis from
Phase 2 dose-expansion cohorts of transcendIT-101 and IL-Believe
trials; (xvi) the ability of the new TransCon technology carrier
platform to unlock large market opportunities where high volume and
low-cost manufacturing is required; (xvii) the potential
best-in-class weekly and monthly administration profiles of
Ascendis’ new TransCon technology carrier platform; (xviii)
Ascendis’ ability to apply its TransCon technology platform to
build a leading, fully integrated global biopharma company; and
(xix) 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, TransCon, and SKYTROFA® are trademarks owned by the Ascendis
Pharma group. © September 2023 Ascendis Pharma A/S.
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 June 30, |
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Six Months ended June 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 |
47,393 |
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|
6,160 |
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|
80,982 |
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|
12,988 |
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Cost of
sales |
12,929 |
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|
1,086 |
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|
17,551 |
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|
5,332 |
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Gross profit |
34,464 |
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|
5,074 |
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|
63,431 |
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|
7,656 |
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Research and
development costs |
105,021 |
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|
90,383 |
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|
211,134 |
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|
173,576 |
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Selling,
general and administrative expenses |
70,281 |
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|
56,584 |
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|
136,820 |
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|
104,002 |
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Operating profit / (loss) |
(140,838 |
) |
|
(141,893 |
) |
|
(284,523 |
) |
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(269,922 |
) |
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Share of
profit / (loss) of associate |
(7,451 |
) |
|
(1,166 |
) |
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(8,677 |
) |
|
(6,039 |
) |
Finance
income |
35,761 |
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|
71,127 |
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|
80,374 |
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|
84,171 |
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Finance
expenses |
9,334 |
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|
9,434 |
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|
18,652 |
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|
14,833 |
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Profit / (loss) before tax |
(121,862 |
) |
|
(81,366 |
) |
|
(231,478 |
) |
|
(206,623 |
) |
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Income taxes
(expenses) |
429 |
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|
47 |
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(868 |
) |
|
(195 |
) |
Net
profit / (loss) for the period |
(121,433 |
) |
|
(81,319 |
) |
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(232,346 |
) |
|
(206,818 |
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Attributable
to owners of the Company |
(121,433 |
) |
|
(81,319 |
) |
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(232,346 |
) |
|
(206,818 |
) |
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Basic and
diluted earnings / (loss) per share |
€ (2.16 |
) |
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€ (1.46 |
) |
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€ (4.14 |
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€ (3.68 |
) |
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Number of
shares used for calculation (basic and diluted) |
56,218,257 |
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55,805,486 |
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56,155,441 |
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56,260,248 |
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Net
profit / (loss) for the period |
(121,433 |
) |
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(81,319 |
) |
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(232,346 |
) |
|
(206,818 |
) |
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 |
(1,016 |
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|
(757 |
) |
|
(1,803 |
) |
|
(332 |
) |
Other comprehensive income / (loss) for the period, net of
tax |
(1,016 |
) |
|
(757 |
) |
|
(1,803 |
) |
|
(332 |
) |
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Total comprehensive income / (loss) for the period, net of
tax |
(122,449 |
) |
|
(82,076 |
) |
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(234,149 |
) |
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(207,150 |
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Attributable
to owners of the Company |
(122,449 |
) |
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(82,076 |
) |
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(234,149 |
) |
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(207,150 |
) |
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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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June 30, |
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December 31, |
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2023 |
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2022 |
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Assets |
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Non-current assets |
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Intangible
assets |
4,606 |
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4,828 |
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Property,
plant and equipment |
125,362 |
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129,095 |
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Investment
in associate |
14,111 |
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22,932 |
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Other
receivables |
2,066 |
|
1,920 |
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Marketable
securities |
- |
|
7,492 |
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|
146,145 |
|
166,267 |
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Current assets |
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Inventories |
167,919 |
|
130,673 |
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Trade
receivables |
20,212 |
|
11,910 |
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Income tax
receivable |
1,360 |
|
883 |
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Other
receivables |
14,127 |
|
12,833 |
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Prepayments |
42,958 |
|
31,717 |
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Marketable
securities |
36,880 |
|
290,688 |
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Cash and
cash equivalents |
394,222 |
|
444,767 |
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|
677,678 |
|
923,471 |
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Total assets |
823,823 |
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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 |
7,699 |
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7,675 |
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Distributable equity |
57,142 |
|
255,673 |
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Total equity |
64,841 |
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263,348 |
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Non-current liabilities |
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Borrowings |
479,374 |
|
482,956 |
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Derivative
liabilities |
86,385 |
|
157,950 |
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Contract
liabilities |
949 |
|
14,213 |
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566,708 |
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655,119 |
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Current liabilities |
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Borrowings |
26,564 |
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25,421 |
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Contract
liabilities |
4,146 |
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- |
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Trade
payables and accrued expenses |
122,120 |
|
101,032 |
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Other
liabilities |
22,860 |
|
31,989 |
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Income tax
payables |
5,773 |
|
5,490 |
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Provisions |
10,811 |
|
7,339 |
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|
192,274 |
|
171,271 |
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Total liabilities |
758,982 |
|
826,390 |
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Total equity and liabilities |
823,823 |
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1,089,738 |
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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 |
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ICR Westwicke |
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+1 (415) 513-1284 |
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patti.bank@westwicke.com |
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* Registered in the U.S. as SKYTROFA® (longapegsomatropin-tcgd)
and in the EU as SKYTROFA® (lonapegsomatropin). SKYTROFA® is not
marketed in the EU.
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