On April 27, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the first quarter ended March 31, 2023 and provided a business update (Press release, Ascendis Pharma, APR 27, 2023, View Source [SID1234630590]).
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"Based on our clinical experience with TransCon PTH to date, we have seen the improvement in the lives of many patients living with hypoparathyroidism and we are committed to working with regulatory authorities in the U.S. and EU to bring it to market as soon as possible," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "We are managing our business to achieve our goal of reaching cash flow breakeven without the need for additional dilutive equity financing, supported by our first approved product, SKYTROFA, which is now accelerating to U.S. market value leadership. With advances across our portfolio and a focus on cost control, we remain on track to achieve Vision 3×3 to become a sustainable, profitable leading biopharma company."
Select Highlights & Anticipated 2023 Milestones
TransCon hGH:
First quarter 2023 SKYTROFA revenue grew to €31.6 million, including a negative foreign currency impact of €1.4 million compared to the previous quarter.
Q1-2022 Q2-2022 Q3-2022 Q4-2022 Q1-2023
SKYTROFA revenue (millions) €1.9 €4.4 €12.3 €17.1 €31.6
SKYTROFA commercial launch in Germany on track for the third quarter of 2023.
Expect topline results from Phase 3 foresiGHt trial in adult growth hormone deficiency in the fourth quarter of 2023.
TransCon PTH:
Committed to working with the FDA to address any NDA deficiencies.
145 of 154 clinical trial participants continue treatment with TransCon PTH for up to 3 years, and U.S. Expanded Access Program continues to enroll new patients.
Submitted application to initiate an early access program in Germany during the second quarter of 2023. If approved, expect to enroll first patient during the second quarter of 2023.
Anticipate European Commission decision on MAA during the fourth quarter of 2023. If approved, first launch planned in Germany in early 2024.
TransCon CNP:
As of March 31, 2023, all 57 patients remain in the open-label extension (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.
Expect to complete target enrollment of ~80 patients in ApproaCH, a global randomized, double-blind, placebo-controlled Phase 2b trial in children ages 2–11 years with achondroplasia, during the second quarter of 2023.
TransCon TLR7/8 Agonist:
Enrollment in the dose expansion portion of the Phase 1/2 transcendIT-101 trial continues, with a focus on investigating TransCon TLR7/8 Agonist in combination with pembrolizumab in four different cancer types.
TransCon IL-2 β/γ
Initial monotherapy dose escalation data from the ongoing Phase 1/2 IL-Believe trial of TransCon IL-2 β/γ alone or in combination with pembrolizumab will be published online at ASCO (Free ASCO Whitepaper) 2023. Dose escalation combination therapy results expected during the third quarter of 2023.
Preparing to initiate Believe-IT-201, a randomized Phase 2 trial of TransCon IL-2 β/γ and TLR7/8 combination therapies, in the second quarter of 2023.
Ended the first quarter of 2023 with cash, cash equivalents, and marketable securities totaling €585.7 million.
First Quarter 2023 Financial Results
Total revenue for the first quarter of 2023 was €33.6 million compared to €6.8 million during the same period in 2022. The increase was primarily attributable to higher SKYTROFA revenue of €31.6 million compared to €1.9 million in the same period last year.
Research and development (R&D) costs for the first quarter were €106.1 million compared to €83.2 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, reflecting the advancement of these product candidates.
Selling, general, and administrative (SG&A) expenses for the first quarter were €66.5 million compared to €47.4 million during the same period in 2022. This increase was primarily due to higher external commercial expenses related to SKYTROFA and to 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 €35.3 million in the first quarter compared to €7.6 million in the same period in 2022.
For the first quarter of 2023, Ascendis Pharma reported a net loss of €110.9 million, or €1.98 per share (basic and diluted) compared to a net loss of €125.5 million, or €2.21 per share (basic and diluted) for the same period in 2022.
As of March 31, 2023, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €585.7 million compared to €742.9 million as of December 31, 2022. As of March 31, 2023, Ascendis Pharma had 57,328,548 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 first 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 View Source A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.