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

Nov 18, 2019 • 04:30 pm ET

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

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Presentation
Executive
Jan Mikkelsen

Growth Hormone is the only long-acting growth hormone product in clinical development that is based on the release of an unmodified human growth hormone. The same as in endorses somatropin. And somatropin used in daily growth hormone products.

Our TransCon technology allows the released unmodified growth hormone to diffuse into the target tissue maximizing its ability to carve out the same effect as in [Indecipherable] or daily growth hormone. We are also developing our once-weekly TransCon Growth Hormone to have the optimal product features from the daily growth hormone products.

We developed our auto-injector to build in optimal product features such as room temperature storage, small injection volume and a needle and an integrated connected healthcare platform also help clinician and our patient with a great adherence and convenience.

We're also making good progress developing our connected healthcare support program. We expect this program to generate data to support adherence and include apps and interface point for both patient and provider at lungs [Phonetic]. We have advanced the TransCon Growth Hormone program from the idea stage all the way through clinical trials involving around 400 patients and we now on the threshold of submitting marketing applications. TransCon Growth Hormone has the potential not only to match the current daily standard but if approved, may in fact offer great high velocity outcome with TransCon PTH, we have followed the exact same development agreement designed to address a major unmet medical need. In hypoparathyroidism, patients are in urgent need of a therapy that sustained physiological levels of PTH 24 hours a day, seven days a week as a true replacement therapy.

The burden of this disease is enormous. With current standard of care, patient and physician must balance the trade-off between managing short-term symptoms and reducing risk of long-term complication. The dilemma is that the treatment of short-term symptoms with calcium and activated vitamin D, at the same time also increase the long-term complications.

Short-term symptoms have a significant impact on patient productivity and daily lives. In our Patient Experience Research, about 30% were no longer able to work and over 76 patient reported interference with work productivity.

Meanwhile, the long-term complication add yet another layer of economic burden to the healthcare system. Complication include kidney failure at 4-fold to 8-fold greater risk with hospitalization or ER method experienced by 79% of patients.

In recent months, this burden has been at the forefront of our minds, given the recall of the only approved PTH therapy for HP in the US, NATPARA.

Since the September recall, we have been talking with sites and patient about their experience. Or recently, we saw that NATPARA might be back on the market and in patient's hands quickly. Then, at a recent patient conference hosted by the HypoPARAthyroidism Association, our team learned how the patient community has been significantly affected by this situation.

We heard stories of desperation from patient faced with difficult choices about their care. Importantly, we also understood that it was uncertain when that