On August 10, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the second quarter ended June 30, 2022, and provided a business update (Press release, Ascendis Pharma, AUG 10, 2022, View Source [SID1234618039]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Our anticipated launch of TransCon PTH in the U.S. next year, combined with our progress towards making SKYTROFA the leading product in a growing growth hormone market, moves us closer to fulfilling our Vision 3×3 and becoming a sustainable, profitable, leading biopharma company," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
Company Highlights & Progress
TransCon hGH:
SKYTROFA revenue continued to double quarter-to-quarter, reaching €4.4 million in the second quarter.
In June 2022, submitted a trial protocol to the FDA to evaluate TransCon hGH in Turner Syndrome.
The foresiGHt Trial in adult GHD on track to complete enrollment by the end of 2022.
Enrollment in the riGHt Trial, a Phase 3 trial in Japan for pediatric GHD, is expected to complete by the end of 2022.
Commercial launch of TransCon hGH planned for Europe in mid-2023.
TransCon PTH:
Following pre-NDA meeting with the FDA, on track to submit regulatory filing in the U.S. during the third quarter of 2022, with expected U.S. launch in mid-2023.
EU MAA submission planned during the fourth quarter of 2022.
After more than two years of treatment in the open-label extension portion of the Phase 2 PaTH Forward Trial, 57 out of 59 original subjects continue in the open label extension portion of the trial as of June 30, 2022.
In the Phase 3 PaTHway Trial, 79 out of 79 patients completed one-year follow-up; 78 out of 79 patients continue in the open-label extension portion of the trial as of June 30, 2022.
TransCon CNP:
Top-line data from the ACcomplisH Trial, a Phase 2 randomized, double-blind, placebo-controlled clinical trial in North America, Europe, and Oceania in children ages 2-10 years with achondroplasia expected in the fourth quarter of 2022.
Planned fourth-quarter regulatory submissions for a new global randomized, double-blind, placebo-controlled Phase 2b trial of TransCon CNP in children down to 2 years of age with achondroplasia.
TransCon TLR7/8 Agonist:
Enrollment continues in transcendIT-101, a Phase 1/2 trial of TransCon TLR7/8 Agonist with or without a checkpoint inhibitor in patients with advanced or metastatic solid tumors who have failed prior lines of therapy.
transcendIT-101 monotherapy and combo-therapy dose escalation top-line data are expected during the third quarter of 2022.
TransCon IL-2 β/γ:
The Phase 1/2 IL-βelieγe Trial evaluating TransCon IL-2 β/γ monotherapy in patients with locally advanced or metastatic solid tumors continues to enroll patients. The Phase 1/2 IL-βelieγe Trial top-line data are expected in the fourth quarter of 2022.
During the second quarter of 2022, dosed first patient in combination checkpoint inhibitor and TransCon IL-2 β/γ dose-escalation arm of the IL-βelieγe Trial.
TransCon TLR7/8 Agonist and TransCon IL-2 β/γ Combination Therapy:
Plan to submit an IND or similar for Phase 2 cohort expansion for TransCon TLR7/8 Agonist and TransCon IL-2 β/γ during the fourth quarter of 2022.
Board of Directors to nominate Bill Fairey, and Siham Imani, both leaders in pharmaceutical commercialization, as new independent board members. The Board of Directors will call into an Extraordinary General Meeting to take place first half of September 2022.
Ended the second quarter of 2022 with cash, cash equivalents, and marketable securities totaling €995 million.
Second Quarter 2022 Financial Results
Total revenue for the second quarter was €6.2 million compared to €1.0 million in the same quarter of 2021. Revenue included U.S. revenue from SKYTROFA, as well as license, clinical supply and services provided to third parties, primarily VISEN Pharmaceuticals. The increase in revenue compared to the same period the prior year was primarily attributable to the €4.4 million commercial revenue from SKYTROFA (lonapegsomatropin-tcgd) in the second quarter following U.S. commercial launch in October 2021.
Research and development (R&D) costs for the second quarter were €90.4 million compared to €83.3 million during the same period in 2021, reflecting primarily higher employee costs resulting from an increase in the number of R&D related personnel.
Selling, general, and administrative (SG&A) expenses for the second quarter were €56.6 million compared to €35.3 million during the same period in 2021. Higher SG&A expenses were primarily due to an increase in commercial and administrative personnel following the launch of SKYTROFA.
Our share of net loss of associate was €1.2 million in the second quarter, compared to a net loss of €4.8 million during the same period in 2021.
Net finance income was €61.7 million in the second quarter compared to a net finance expense of €12.0 million in the same period in 2021.
For the second quarter of 2022, Ascendis Pharma reported a net loss of €81.3 million, or €1.46 per share (basic and diluted) compared to a net loss of €134.4 million, or €2.50 per share (basic and diluted) for the same period in 2021.
As of June 30, 2022, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €994.9 million compared to €789.6 million as of December 31, 2021. As of June 30, 2022, Ascendis Pharma had 56,965,058 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 2022 financial results.
Those who would like to listen to the live webcast can access it through the following link. To access the live teleconference, register online here. Participants are encouraged to register at least 15 minutes prior to the call.
A replay of the webcast will be available on the Investors & News section of the Ascendis Pharma website at View Source shortly after conclusion of the event for 30 days.