Chiasma Reports Fourth Quarter and Full-Year 2020 Financial Results and Provides Corporate Update
Phased launch of MYCAPSSA® progressing with 2020 net product revenue of
Achieved payor coverage of MYCAPSSA for over 150 million lives
Company to host conference call today,
Recent Business Highlights
U.S.phased launch of MYCAPSSA® in September 2020with reported 2020 net product revenue of $1.1 million, primarily from the fourth quarter
- Secured payor coverage of MYCAPSSA for over 150 million lives in 2020
- Demonstrated non-inferiority of MYCAPSSA to long-acting injectable somatostatin analogs for maintenance of biochemical response in patients with acromegaly in the top-line results of the MPOWERED Phase 3 study
- Enrolled over 200 acromegaly patients to date, requiring long-term medical therapy into the MACRO disease state registry denoting strong interest in understanding the current state of care
- Complemented the management team with the appointment of
John Doyleas Chief Financial Officer
- Exited the fourth quarter with
$135.4 millionof cash, cash equivalents and marketable securities (exclusive of approximately $20.6 million of restricted cash)
Anticipated Upcoming 2021 Milestones
- Continued growth of MYCAPSSA revenue by building on the
U.S.commercial launch progress achieved to date and the planned expansion of the commercial team in 2021 when market conditions warrant
- Presentation of five accepted late-breaker abstracts from the MPOWERED Phase 3 Study planned at the upcoming virtual 2021
Endocrine SocietyAnnual Meeting (ENDO) later this month
- Oral presentation on longer-term efficacy and safety data from the open-label extension of the CHIASMA OPTIMAL Phase 3 trial planned for the upcoming virtual 2021 ENDO Meeting
- Planned submission of the MPOWERED Study results to a peer-reviewed medical journal in 2021
- Submission of a Marketing Authorization Application (MAA) to the
European Medicines Agency(EMA) for MYCAPSSA seeking EU regulatory approval planned for mid-2021
“We continue to gain traction with our phased launch of MYCAPSSA and are encouraged by the positive feedback from physicians and patients,” stated
“With respect to the COVID-19 pandemic we have continued to experience a challenging environment with reduced patient visits to their physicians and limited access to customers for our commercial team. In anticipation of some of these headwinds, we implemented digital and virtual programs and also phased the hiring of our customer-facing team with the final phase of hiring planned for when market conditions warrant,” concluded
Fourth Quarter and Full-Year 2020 Financial Results
Product Revenue, Net: Net product revenue related to the sales of MYCAPSSA were approximately
SG&A Expenses: Selling, general and administrative expenses were
R&D Expenses: Research and development expenses were
Net Loss: Net loss for the fourth quarter of 2020 was
Cash Position: Chiasma ended 2020 with cash, cash equivalents, and marketable securities of
2021 Financial Guidance: As previously stated, operating expenses for the full year 2021 are expected to be in a range of
Conference Call and Webcast Information
Chiasma management will host a conference call and webcast to discuss the fourth 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 the webcast will be available on the company’s website approximately two hours after the event. The archived webcast will be available for one year.
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. In
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, the commercialization of MYCAPSSA, including potential market adoption and commercial success, the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care and the anticipated market acceptance and third-party reimbursement of and access to MYCAPSSA, the expansion of the customer-facing team, 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, the presentation and publication plans for the data from the MPOWERED trial, and the company’s financial guidance, including operating expense and cash runway guidance. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company’s control, that may cause actual events or results to differ materially from the company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release 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 or EMA, the sufficiency of the data collected from the company’s clinical trials to obtain regulatory approval in the European Union or elsewhere, the company’s ability to retain requisite regulatory approvals for the continued commercial sale 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 twelve months ended|
|Product revenue, net||$||964||$||—||$||1,106||$||—|
|Cost of goods sold||58||—||61||—|
|Selling, general and administrative||13,597||5,912||44,892||15,122|
|Research and development||4,482||6,354||26,802||22,457|
|Total operating expenses||18,079||12,266||71,694||37,579|
|Loss from operations||(17,173||)||(12,266||)||(70,649||)||(37,579||)|
|Interest and other income, net||178||469||1,826||1,543|
|Loss before income taxes||(19,834||)||(11,797||)||(74,695||)||(36,036||)|
|Provision (benefit) for income taxes||(26||)||250||84||284|
|Earnings per share of common stock:|
|Weighted-average shares outstanding:|
|Condensed Consolidated Balance Sheets Information|
|(amounts in thousands)|
|Cash and cash equivalents||$||15,462||$||27,855|
|Prepaid expenses and other current assets||6,444||3,881|
|Property and equipment, net||534||334|
|Other current liabilities||633||546|
|Deferred royalty obligation||63,548||-|
|Total stockholders' equity||91,785||85,769|
|Total liabilities and stockholders' equity||$||176,338||$||98,826|