Chiasma Reports Third Quarter 2020 Results and Provides MYCAPSSA Launch Update
Launched MYCAPSSA® in
Well capitalized to support the MYCAPSSA launch
On track to announce MPOWERED™ Phase 3 trial topline data this month
Company to host conference call today,
Recent Business Highlights and Upcoming Milestones
- Launched MYCAPSSA in September, the first and only oral somatostatin analog (SSA) with the potential to become the new standard of pharmacological care in the long-term maintenance treatment of patients with acromegaly;
- Announced publication of CHIASMA OPTIMAL Phase 3 clinical trial results in the prestigious
Journal of Clinical Endocrinology & Metabolism;
- Continued to enroll patients in the MACRO registry, the first ever industry-sponsored acromegaly disease state registry in
the United States;
- Exited the third quarter with
$177.1 millionof cash, cash equivalents, marketable securities and restricted cash; and
- MPOWERED Phase 3 clinical trial topline data expected later this month that, if positive, are expected to provide head-to-head data against injectable octreotide and lanreotide and support a planned regulatory submission for MYCAPSSA for the treatment of acromegaly in the
“I am pleased that we were able to launch MYCAPSSA earlier than expected. I commend the dedicated team at Chiasma for the launch progress we have made to date. During this initial phase, our customer-facing team has made solid progress reaching targeted healthcare providers, generating patient enrollment forms, and gaining access for MYCAPSSA with payers,” stated
Third Quarter 2020 Financial Results
Product Revenues, Net: Net product revenues were approximately
SG&A Expenses: Selling, general and administrative expenses were
R&D Expenses: Research and development expenses were
Net Loss: For the quarter ended
Cash Position: Chiasma ended the third quarter with cash, cash equivalents, marketable securities and restricted cash of
Conference Call and Webcast Information
Chiasma management will host a conference call and webcast to discuss its third quarter results in more detail today,
A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company’s website approximately two hours after the event. The archived webcast will be available for one year.
MPOWERED™ Phase 3 Clinical Trial
Chiasma is conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the Company’s octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as MPOWERED, is a global, randomized, open-label and active-controlled, 15-month trial intended to support approval in the
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.
Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.
The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.
Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.
Advise premenopausal females of the potential for an unintended pregnancy.
To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in
Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, statements regarding the commercialization of MYCAPSSA, including its reimbursement and market adoption, statements concerning the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care and the anticipated market acceptance of and access to MYCAPSSA, statements concerning the success of a commercial launch of MYCAPSSA in
Investor Relations and Corporate Communications:
|Condensed Consolidated Statements of Operations|
|(amounts in thousands except share and per share data)|
|For the three months ended||For the nine months ended|
|Product revenue, net||$||142||$||—||$||142||$||—|
|Cost of goods sold||3||—||3||—|
|Selling, general and administrative||13,048||4,116||31,295||9,210|
|Research and development||4,523||4,110||22,320||16,103|
|Total operating expenses||17,571||8,226||53,615||25,313|
|Loss from operations||(17,432||)||(8,226||)||(53,476||)||(25,313||)|
|Interest and other income, net||1,122||549||1,648||1,074|
|Loss before income taxes||(18,436||)||(7,677||)||(54,861||)||(24,239||)|
|Provision for income taxes||21||6||110||34|
|Earnings per share of common stock:|
|Weighted-average shares outstanding:|
|Condensed Consolidated Balance Sheets Information|
|(amounts in thousands)|
|Cash and cash equivalents||$||72,840||$||27,855|
|Prepaid expenses and other current assets||5,383||3,881|
|Property and equipment, net||581||334|
|Other current liabilities||722||546|
|Deferred royalty obligation||63,529||-|
|Total stockholders' equity||110,338||85,769|
|Total liabilities and stockholders' equity||$||194,561||$||98,826|