Chiasma Reports First Quarter Financial Results and Announced Agreement to Merge with Amryt
Announced agreement to merge with Amryt
Combination to create a global commercial stage rare and orphan disease leader with a diversified portfolio of therapies and a meaningful late-stage development pipeline
Q1 2021 Net Product Revenues of
Achieved payor coverage of MYCAPSSA for over 185 million lives
Submitted an Investigational New Drug (IND) application for the study of MYCAPSSA in patients with carcinoid syndrome associated with Neuroendocrine Tumors (NET)
Recent Business Highlights
- Announced entry into a definitive merger agreement for the acquisition of the company by Amryt Pharma plc, a biopharmaceutical company focused on acquiring, developing and delivering innovative treatments to help improve the lives of patients with rare and orphan diseases
- Generated MYCAPSSA net product revenue of
$1.9 millionin Q1 2021
- Increased payor coverage of MYCAPSSA to over 185 million lives
- Submitted an Investigational New Drug (IND) application to the FDA for a Phase 1 relative bioavailability study followed by a single Phase 3 randomized, double-blind, placebo-controlled study of MYCAPSSA in patients with carcinoid syndrome associated with NET. These studies are designed to support a potential modified 505(b)(2) regulatory pathway.
- Exited the first quarter with
$115.0 millionof cash, cash equivalents and marketable securities
“While we continue to experience customer access challenges related to COVID-19, we are pleased with the launch progress we made in the first quarter and it reiterates our intent of making MYCAPSSA the new standard of pharmacological care,” stated
“Importantly, we believe the merger with Amryt represents a transformational moment in unlocking and accelerating the potential value of Chiasma efficiently for both our patients and for our shareholders,” concluded
First Quarter 2021 Financial Results
Product Revenue, Net: Net product revenue related to the sales of MYCAPSSA were
SG&A Expenses: Selling, general and administrative expenses were
R&D Expenses: Research and development expenses were
Net Loss: Net loss for the first quarter of 2021 was
Cash Position: Chiasma ended the first quarter 2021 with cash, cash equivalents, and marketable securities of
Conference Call Information
Given the recently announced agreement for Chiasma to be acquired by Amryt, Chiasma will not be hosting a conference call.
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
About Neuroendocrine Tumors
NETs arise from neuroendocrine cells throughout the body, most commonly in the gastrointestinal tract, lung, and rarely, the pancreas. While well differentiated neuroendocrine tumors are known to be slow growing, they are often asymptomatic in early stages leading to a substantial number of patients being diagnosed when the tumors have already spread regionally or distantly. Capable of secreting hormones and bioactive amines, approximately 19% of patients have carcinoid syndrome characterized by secretory diarrhea and flushing. With an annual incidence rate of 6.98 per 100,000, it is estimated there are greater than 170,000 individuals living with a diagnosis of NET 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
Important Additional Information and Where to Find It
In connection with the proposed transaction, Amryt intends to file with the
Investors and security holders may obtain copies of these documents, once such documents are filed with the
No Offer or Solicitation
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the
Participants in Solicitation
Amryt and Chiasma and certain of their respective directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Chiasma in respect of the proposed transaction under the rules of the
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 proposed acquisition of the company by Amryt, the potential development of MYCAPSSA as a treatment for neuroendocrine tumors, 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 and the commercial or therapeutic potential of MYCAPSSA. 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: uncertainties related to the timing and occurrence of the closing of the proposed acquisition of the company by Amryt, the reaction to the proposed acquisition by our business partners as well as our customers and patients, the reaction by competitors to the proposed acquisition, the retention of our employees, Amryt’s plans for us, the future growth of our and Amryt’s businesses and the possibility that integration following the proposed acquisition may be more difficult than expected; the content and timing of decisions made by the FDA or EMA, 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|
|Product revenue, net||$||1,924||$||—|
|Cost of goods sold||67||—|
|Selling, general and administrative||15,698||7,582|
|Research and development||4,199||8,125|
|Total operating expenses||19,897||15,707|
|Loss from operations||(18,040||)||(15,707||)|
|Interest and other income (loss), net||(9,583||)||398|
|Loss before income taxes||(30,496||)||(15,309||)|
|Provision for income taxes||52||77|
|Earnings per share of common stock:|
|Weighted-average shares outstanding:|
|Condensed Consolidated Balance Sheets Information|
|(amounts in thousands)|
|Cash and cash equivalents||$||24,576||$||15,462|
|Prepaid expenses and other current assets||6,603||6,444|
|Property and equipment, net||487||534|
|Other current liabilities||625||633|
|Deferred royalty obligation||73,368||63,548|
|Total stockholders' equity||62,688||91,785|
|Total liabilities and stockholders' equity||$||159,535||$||176,338|