On November 2, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the third quarter ended September 30, 2022 and provided a business update (Press release, Ascendis Pharma, NOV 2, 2022, View Source [SID1234622858]).

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"With our improved commercial execution and emphasis on SKYTROFA’s unique patient-focused product strengths, I believe we are advancing our goal to build SKYTROFA into the leading brand and expand the pediatric growth hormone market," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "With our expanding global commercial activities, potential U.S. approval of TransCon PTH in April 2023, and new data expected in achondroplasia and oncology, I am confident in our ability to deliver multiple high-value products to drive long-term sustainable growth."

Select Highlights

TransCon hGH:
SKYTROFA (lonapegsomatropin-tcgd) U.S. revenue more than doubled quarter-to-quarter again to €12.3 million in the third quarter. As of September 30, 2022, the cumulative number of new patient prescriptions increased to over 2,400.
On track to complete enrollment in the global Phase 3 foresiGHt Trial in adult growth hormone deficiency (GHD) during the fourth quarter of 2022.
Endocrinology Rare Disease commercial center for Germany planned in Munich; Skytrofa (lonapegsomatropin) launch in Germany expected mid-2023.
TransCon PTH:
U.S. FDA accepted for Priority Review NDA submission in adult patients with hypoparathyroidism; PDUFA target action date is April 30, 2023.
MAA submission to EMA on track for the fourth quarter of 2022.
Topline results from Phase 3 PaTHway Japan Trial expected during fourth quarter of 2022.
After more than two years of treatment, 57 out of 59 patients continue in the open-label extension portion of the Phase 2 PaTH Forward Trial as of September 30, 2022.
In the Phase 3 PaTHway Trial, 79 out of 79 patients completed one-year follow-up; 77 out of 79 patients continue in the open-label extension portion of the trial as of September 30, 2022.
TransCon CNP:
Topline and initial open-label extension data from ACcomplisH, a Phase 2 randomized, double-blind, placebo-controlled clinical trial in children ages 2-10 years with achondroplasia, expected during the fourth quarter of 2022; 57 out of 57 patients continue in the open-label portion of the trial as of September 30, 2022.
Submitted protocol to initiate ApproaCH, a new global randomized, double-blind, placebo-controlled Phase 2b trial in children ages 2-11 years with achondroplasia. The trial is expected to enroll approximately 80 patients.
TransCon TLR7/8 Agonist:
Completed the dose-escalation portion and announced selection of recommended Phase 2 dose in transcendIT-101. Topline data accepted for oral presentation at SITC (Free SITC Whitepaper) 2022, the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held in Boston November 8-12.
The next phase of transcendIT-101 will evaluate the recommended Phase 2 dose of investigational TransCon TLR7/8 Agonist in combination with pembrolizumab in patients in four different indication-specific cohorts: head and neck squamous cell carcinoma (HNSCC); other human papillomavirus (HPV)-associated cancers; melanoma; and cutaneous squamous cell carcinoma (cSCC).
TransCon IL-2 β/γ
The Phase 1/2 IL-βelieγe Trial evaluating investigational 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 topline data from monotherapy dose escalation are expected during the fourth quarter of 2022.
Ended the third quarter of 2022 with cash, cash equivalents, and marketable securities totaling €935 million.
Third Quarter 2022 Financial Results

Total revenue for the third quarter was €15.3 million compared to €1.1 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 last year was primarily attributable to the €12.3 million commercial revenue from SKYTROFA.

Research and development (R&D) costs for the third quarter were €97.4 million compared to €58.8 million during the same period in 2021. Lower R&D costs in the third quarter of 2021 reflect a one-time €53.7 million reversal of pre-launch inventories, which had previously been recognized as research and development costs. The third quarter 2022 R&D costs also reflect the manufacturing of pre-launch inventories for TransCon PTH and an increase in employee and other costs attributable to organizational growth.

Selling, general, and administrative (SG&A) expenses for the third quarter were €60.7 million compared to €39.3 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 in the U.S. and preparation for future product launches.

Our share of net loss of associate was €3.7 million in the third quarter, compared to a net loss of €3.9 million during the same period in 2021.

Net finance loss was €20.9 million in the third quarter compared to a net finance income of €20.4 million in the same period in 2021.

For the third quarter of 2022, Ascendis Pharma reported a net loss of €169.0 million, or €3.03 per share (basic and diluted) compared to a net loss of €80.3 million, or €1.47 per share (basic and diluted) for the same period in 2021.

As of September 30, 2022, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €935.1 million compared to €789.6 million as of December 31, 2021. As of September 30, 2022, Ascendis Pharma had 57,027,240 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 third quarter 2022 financial results.

Those who would like to listen to the live webcast can access it through the following link here. 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.