Post by luxetvox on May 2, 2024 22:03:12 GMT
Ascendis Pharma Reports First Quarter 2024 Financial Results
2024-05-02 20:01:00.10 GMT
— Rollout of YORVIPATH^® initiated in Germany and Austria, with an estimated
55 doctors writing prescriptions and ~100 patients receiving commercial
product as of March 31
— TransCon™ 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^® Q1 revenue more than doubled year-over-year to €65 million; Q1
operating expenses fell by 20% year-over-year to €137 million
— Ascendis remains on track for achieving full-year 2024 SKYTROFA revenue of
€320 to €340 million and full year 2024 operating expenses of €600 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
o TransCon hGH:
(lonapegsomatropin, approved as SKYTROFA in the U.S., EU, European
Economic Area (EEA) countries, and Great Britain)
o First quarter 2024 SKYTROFA revenue totaled €65 million, a 106% year
over year increase with a steady quarter to quarter increase in
treated patients.
o Full year 2024 SKYTROFA revenue expected to be €320 million to €340
million (based on average 2023 exchange rates).
o Plan to submit a supplemental Biologics License Application to FDA
for adult growth hormone deficiency (GHD), in the third quarter of
2024.
o Topline results from Phase 2 trial in Turner syndrome expected in the
fourth quarter of 2024.
o TransCon PTH:
(palopegteriparatide, approved as YORVIPATH in the EU, EEA countries, and
Great Britain)
o 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.
o 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.
o Granted marketing authorization for the treatment of adults with
chronic hypoparathyroidism and orphan drug status in Great Britain.
o TransCon CNP:
(navepegritide)
o 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.
o 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.
o Oncology Programs
o 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.
o 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.
o Financial Update and Outlook Based on Current Plans
o 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.
o Full year 2024 SKYTROFA revenue expected to be €320 million to €340
million (based on average 2023 exchange rates).
o Expect total operating expenses (SG&A and R&D) of approximately €600
million for 2024.
o 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 €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.
Just think, with a 1 for 10 reverse split of Phil's Dilution Machine (housed inside his Cash Incinerator), Opko could achieve a similarly reasonable share count. Hmmm, but would the pizza actually be smaller?
2024-05-02 20:01:00.10 GMT
— Rollout of YORVIPATH^® initiated in Germany and Austria, with an estimated
55 doctors writing prescriptions and ~100 patients receiving commercial
product as of March 31
— TransCon™ 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^® Q1 revenue more than doubled year-over-year to €65 million; Q1
operating expenses fell by 20% year-over-year to €137 million
— Ascendis remains on track for achieving full-year 2024 SKYTROFA revenue of
€320 to €340 million and full year 2024 operating expenses of €600 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
o TransCon hGH:
(lonapegsomatropin, approved as SKYTROFA in the U.S., EU, European
Economic Area (EEA) countries, and Great Britain)
o First quarter 2024 SKYTROFA revenue totaled €65 million, a 106% year
over year increase with a steady quarter to quarter increase in
treated patients.
o Full year 2024 SKYTROFA revenue expected to be €320 million to €340
million (based on average 2023 exchange rates).
o Plan to submit a supplemental Biologics License Application to FDA
for adult growth hormone deficiency (GHD), in the third quarter of
2024.
o Topline results from Phase 2 trial in Turner syndrome expected in the
fourth quarter of 2024.
o TransCon PTH:
(palopegteriparatide, approved as YORVIPATH in the EU, EEA countries, and
Great Britain)
o 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.
o 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.
o Granted marketing authorization for the treatment of adults with
chronic hypoparathyroidism and orphan drug status in Great Britain.
o TransCon CNP:
(navepegritide)
o 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.
o 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.
o Oncology Programs
o 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.
o 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.
o Financial Update and Outlook Based on Current Plans
o 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.
o Full year 2024 SKYTROFA revenue expected to be €320 million to €340
million (based on average 2023 exchange rates).
o Expect total operating expenses (SG&A and R&D) of approximately €600
million for 2024.
o 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 €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.
Just think, with a 1 for 10 reverse split of Phil's Dilution Machine (housed inside his Cash Incinerator), Opko could achieve a similarly reasonable share count. Hmmm, but would the pizza actually be smaller?
