Chiasma Overview
January 2021 | NASDAQ: CHMA
Forward-Looking Statements
These slides and the accompanying presentation contain forward-looking statements and information. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements. These statements include, without limitation, those statements regarding the company's expectations relating to MYCAPSSA for the long-term maintenance treatment in patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide, statements regarding the commercialization of MYCAPSSA, including its pricing, reimbursement, payer mix and market adoption, statements regarding the data from the open label extension of the CHIASMA OPTIMAL trial, statements regarding the size and composition of the U.S. market for MYCAPSSA, the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care, and anticipated market acceptance of and access to MYCAPSSA, statements regarding the expansion of its customer-facing team, statements regarding the success of commercial launch of MYCAPSSA in the United States, statements regarding the company's expectations regarding formulary coverage for MYCAPSSA, statements regarding the data from the MPOWERED trial and whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval, statements regarding the timing of an MAA submission and regulatory review, statements regarding the company's plans for the presentation of the full trial results, statements regarding the potential commercialization of MYCAPSSA in the European Union and in other jurisdictions, statements concerning the utilization of TPE platform to develop new therapeutic agents, and statements regarding Chiasma's commercial organization and efforts and potential sales and revenue growth. All forward-looking statements are based on estimates and assumptions by Chiasma's management that, although Chiasma believes them to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Chiasma expects. Management's expectations and, therefore, any forward-looking statements in these slides and the accompanying presentation could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the manufacturing supplements to the company's approved new drug application, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture active pharmaceutical ingredient and commercial octreotide capsules, the company's ability to retain requisite regulatory approvals for the commercial sale of octreotide capsules in the United States, the content and timing of decisions made by the EMA, the sufficiency of the data collected from the company's clinical trials to obtain regulatory approval in the European Union or elsewhere, and the timing and costs involved in commercializing MYCAPSSA, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. These and other potential risks, uncertainties and other important factors are described under the heading "Risk Factors" in our Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission, or SEC, as well as in Chiasma's subsequent filings with the SEC. Undue reliance should not be placed on any forward-looking statement, which speak only as of the date on which it was made. Chiasma undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Unless otherwise noted, all references to acromegaly market sizes are Chiasma internal estimates. This presentation is intended only for communications with investors. MYCAPSSA has been approved by the FDA for the long-term maintenance treatment in patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide, but remains an investigational drug outside the U.S.
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Chiasma Overview
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Commercial biopharma company
Focused on oral treatment options for patients facing significant challenges with injectables
• MYCAPSSA® was FDA approved in June 2020 and launched in September 2020 as the
first and only oral somatostatin analog (SSA) for patients with acromegaly | |
• Acromegaly patients on SSA injectables face significant treatment challenges | |
• Attractive U.S. commercial opportunity ~8,000 patients* on first line SSA injectables | |
• MYCAPSSA has the potential to become the new standard of pharmacological care** | |
• Strong cash position as of Dec. 31, 2020; ~$135M in cash, cash equivalents, | |
Financial Position | and marketable securities (unaudited) |
• Well-capitalized to support U.S. commercial launch execution |
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Validated technology delivery platform with approval of MYCAPSSA in acromegaly Novel technology platform that can enable oral delivery of select therapeutic agents
* Company estimate based on available data. | 3 |
** Full prescribing information available at www.MYCAPSSA.com |
Acromegaly U.S. Market Overview
Acromegaly is a rare disease most often caused by a benign pituitary tumor and
characterized by an excess of growth hormone and insulin-like growth factor-1 hormone. Treatment options include surgery, medication and radiation or a combination of these.
If untreated, acromegaly may cause
Altered facial | Enlargement of the | Type 2 | Intense | Joint | Respiratory | Cardiac | Cerebrovascular | Enlarged |
appearance | hands and feet | diabetes | headaches | pain | disorders | disease | disease | organs |
Octreotide and lanreotide | Potential addressable | ~90% of these patients are |
injections are broadly used as | patient population of | treated at fewer than 1,000 |
first-line pharmacological | z | |
~8,000 patients in | medical centers | |
treatments | the U.S.* |
The global market for SSAs in the treatment of acromegaly is estimated at ~$800 million with U.S. estimated at ~$400 million *
*Company estimate based on available data.
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Chiasma Inc. published this content on 19 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 19 January 2021 12:55:01 UTC