Ascendis Pharma A/S (NASDAQ:ASND) Q3 2019 Earnings Conference Call - Final Transcript

Nov 18, 2019 • 04:30 pm ET


Ascendis Pharma A/S (NASDAQ:ASND) Q3 2019 Earnings Conference Call - Final Transcript


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Scott T. Smith

the third quarter were EUR46.3 million compared to EUR31.5 million during the same period in 2018. Higher R&D costs during the 2019 quarter reflect increased personnel and infrastructure costs due to growth in headcount to support development of our product candidates, then for TransCon Growth Hormone costs were higher, primarily due to increasing costs for manufacturing of validation batches and initial costs of building inventory in anticipation of a commercial launch which for now will be recognized as R&D costs when incurred.

Declining clinical trial costs following the completion of our phase 3 heiGHt Trial. For TransCon PTH, costs were slightly lower, primarily due to a decline in the preclinical and in -- due to a decline in costs for preclinical research and manufacturing, which were partially offset by higher costs associated with our phase 2 PaTH Forward clinical Trial. For TransCon CNP, costs were slightly higher, primarily due to an increase in clinical trial costs related to our ACHieve Study and ACcomplisH Trial which were partially offset by lower manufacturing costs.

Other R&D costs were higher, primarily reflecting activities within our oncology therapeutic area. As a reminder, our R&D expenses, including manufacturing-related expenses vary from quarter-to-quarter reflecting the timing of ongoing development activities. General and administrative expenses for the third quarter of 2019 were EUR10 million compared to EUR6.8 million during the 2018 period.

These higher costs primarily reflect an increase in personnel and site costs as well as costs of building out commercial capabilities. We ended the third quarter with cash and cash equivalents of EUR658.7 million and 47,739,647 ordinary shares outstanding. As a reminder, our quarterly ending cash balance may be impacted by a combination of items, including exchange rate and working capital fluctuations, which this quarter led to a net positive impact on the ending cash balance.

During the quarter, we continued to execute on our Vision 3x3 strategic road map, including completing our long-term clinical follow up and manufacturing of drug product PPQ batches for TransCon Growth Hormone and increasing our global reach through VISEN's initiation of a phase 3 trial of TransCon Growth Hormone in Greater China.

And looking forward, over the near term, we plan to continue progress toward a BLA filing for TransCon Growth Hormone in the first half of next year and the MAA filing in Europe in the second half of next year. Continued growth of our endocrinology rare disease pipeline through label expansion of TransCon Growth Hormone into adult GHD and expansion of our phase 2 trial of TransCon PTH to include subjects previously treated with short-acting PTH.

Report our topline phase 2 TransCon PTH data in Q1, 2020 and open label extension data for up to six months during 2020. Continue execution on the TransCon CNP ACcomplisH Trial as we march toward identifying an effective dose in 2020, advance our oncology product candidates toward first IND or equivalent filing in 2020 and continue increasing global reach for our endocrinology rare disease pipeline .

Operator, we're now ready to