Ascendis Pharma Reports First Quarter 2024 Financial Results
-- Rollout of YORVIPATH$(R)$ initiated in Germany and Austria, with an estimated 55 doctors writing prescriptions and 100 patients receiving commercial product as of March 31
-- TransCon$(TM)$ PTH (palopegteriparatide) PDUFA date of May 14, 2024, for adults with hypoparathyroidism. If approved, U.S. launch planned in Q3
-- TransCon CNP (navepegritide) pivotal ApproaCH Trial on track for topline results in Q4 2024
-- SKYTROFA(R) Q1 revenue more than doubled year-over-year to EUR65 million; Q1 operating expenses fell by 20% year-over-year to EUR137 million
-- Ascendis remains on track for achieving full-year 2024 SKYTROFA revenue of EUR320 to EUR340 million and full year 2024 operating expenses of EUR600 million
-- Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, May 02, 2024 (GLOBE NEWSWIRE) -- 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 EUR65 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 EUR320 million to
EUR340 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 EUR1.5 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
<BETA>/<GAMMA> 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 <BETA>/<GAMMA> 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 EUR320 million compared to
EUR399 million as of December 31, 2023.
-- Full year 2024 SKYTROFA revenue expected to be EUR320 million to
EUR340 million (based on average 2023 exchange rates).
-- Expect total operating expenses (SG&A and R&D) of approximately
EUR600 million for 2024.
-- Expect to be operating cash flow breakeven on a quarterly basis by
the end of 2024.
First Quarter 2024 Financial Results
Total revenue for the first quarter of 2024 was EUR95.9 million compared to EUR33.6 million during the same period for 2023. The increase was primarily attributable to higher SKYTROFA revenue of EUR65.0 million compared to EUR31.6 million in the same period last year and non-cash license revenue of EUR24.8 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 EUR70.7 million compared to EUR106.1 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 EUR66.8 million compared to EUR66.5 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 EUR137.5 million compared to EUR172.7 million during the same period in 2023.
Net finance expenses for the first quarter of 2024 were EUR73.6 million compared to a net finance income of EUR35.3 million during the same period in 2023.
For the first quarter of 2024, Ascendis Pharma reported a net loss of EUR131.0 million, or EUR2.30 per share (basic and diluted) compared to a net loss of EUR110.9 million, or EUR1.98 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 EUR320.2 million compared to EUR399.4 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 Information
Ascendis 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/S
Ascendis 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.
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