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ASCENDIS PHARMA A/S

(ASND)
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Ascendis Pharma A/S : Q2 Earnings and Skytrofa« FDA Approval Call

08/25/2021 | 04:41pm EST

Ascendis Pharma A/S

SKYTROFA® FDA Approval

August 25, 2021

For investor communication only. Not for use in product promotion.

1

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Cautionary Note On Forward-Looking Statements

This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, such as statements regarding our future results of operations and financial position, including our business strategy, expectations regarding the potential benefits of Skytrofa, expectations regarding the projected timing of availability of Skytrofa, expectations regarding a patient support services, availability of funding, clinical trial results, product approvals and regulatory pathways, collaborations, licensing or other arrangements, the potential market size and size of the potential patient populations for Skytrofa and our other product candidates, timing and likelihood of success, plans and objectives of management for future operations, our ability to integrate data informatics to create innovative patient care solutions and enhance patient care, the scope, progress, results and costs of developing our product candidates or any other future product candidates, and future results of current and anticipated products are forward-looking statements. These forward-looking statements are based on our current expectations and beliefs, as well as assumptions concerning future events. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the results discussed in the forward-looking statements. These risks, uncertainties and other factors are more fully described in our reports filed with or submitted to the Securities and Exchange Commission, including, without limitation, our most recent Annual Report on Form 20-F filed with the SEC on April 3, 2020 particularly in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". In light of the significant uncertainties in our forward-looking statements, you should not place undue reliance on these statements or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all.

Any forward-looking statement made by us in this presentation speaks only as of the date of this presentation and represents our estimates and assumptions only as of the date of this presentation. Except as required by law, we assume no obligation to update these statements publicly, whether as a result of new information, future events, changed circumstances or otherwise after the date of this presentation.

Skytrofa has been approved by the U.S. Food and Drug Administration for the treatment of pediatric growth hormone deficiency. Skytrofa is and has been under clinical investigation and has not yet been approved for marketing by the European Medicines Agency or other foreign regulatory authorities.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are

2 trademarks owned by the Ascendis Pharma Group. © August 2021 Ascendis Pharma A/S.

For investor communication only. Not for use in product promotion. Do not distribute.

SKYTROFA® Now FDA Approved

First FDA-approvedonce-weekly product for pediatric growth hormone deficiency (GHD)

First FDA-approved product utilizing TransCon technology

For investor communication only. Not for use in product promotion.

3

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Skytrofa: Select Highlights of U.S. Prescribing Information

INDICATIONS AND USAGE

Skytrofa is a human growth hormone indicated for the treatment of pediatric patients 1 year and older

who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth

hormone (GH)

DOSAGE AND ADMINISTRATION

Skytrofa should be administered subcutaneously into the abdomen, buttock, or thigh with regular

rotation of the injection sites.

The recommended dose is 0.24 mg/kg body weight once-weekly.

Safety

Skytrofa is contraindicated in patients with:

Acute critical illness after open heart surgery, abdominal surgery or multiple accidental

trauma, or those with acute respiratory failure due to the risk of increased mortality with use of

pharmacologic doses of somatropin

Hypersensitivity to somatropin or any of the excipients in Skytrofa

Children with closed epiphyses

Active malignancy

Active proliferative or severe non-proliferativediabetic retinopathy

Prader-Willisyndrome who are severely obese, have a history of upper airway obstruction or

sleep apnea or have severe respiratory impairment due to the risk of sudden death

Adverse Reactions: Most common adverse reactions (≥5%) were viral infection (15%), pyrexia (15%),

cough (11%), nausea and vomiting (11%), hemorrhage (7%), diarrhea (6%), abdominal pain

(6%), and arthralgia and arthritis (6%).

4

For investor communication only. Not for use in product promotion.

Do not distribute.

Limited Innovation Since rhGH was Introduced >30 Years Ago

First FDA approval of

daily recombinant human GH (1985)

First FDA approval of a hGH with room-temperature storage (2006)

First pre-filled injection pen in

the US (2004)

First FDA approval of a once-weekly

treatment for pediatric growth hormone deficiency with in-use room temperature storage for 6 months (2021)

1985

1990

1995

2000

2005

2010

2015

2020

2025

For investor communication only. Not for use in product promotion.

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This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Ascendis Pharma A/S published this content on 25 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 August 2021 20:40:08 UTC.


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Sales 2021 7,69 M 8,71 M 8,71 M
Net income 2021 -401 M -454 M -454 M
Net cash 2021 677 M 766 M 766 M
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Albert Cha Chairman
Birgitte Volck SVP, Head-Clinical Development & Medical Affairs
Kennett Sprog°e Senior Vice President, Head-Innovation & Research
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