STOUGHTON, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that it has completed the acquisition of Ironshore Therapeutics Inc., a privately held company that markets and distributes Jornay PM (methylphenidate HCl), a central nervous system (CNS) stimulant for the treatment of attention deficit hyperactivity disorder (ADHD). Collegium also updated its 2024 financial guidance to include the anticipated impact of the Ironshore acquisition.
“We are pleased to have successfully closed the acquisition of Ironshore, which represents an important milestone as we build a leading, diversified specialty pharmaceutical company,” said Michael Heffernan, Chairman and Interim President and Chief Executive Officer of Collegium. “With the addition of Jornay PM to our portfolio, we are establishing our presence in the large and growing ADHD market with a highly differentiated product that is poised to become our leading growth driver. By leveraging our core commercial competencies and proven track record of efficiently and successfully integrating commercial products, we are well positioned to maximize our pain portfolio, seamlessly integrate Jornay PM, and the Ironshore team, into our business and deliver on the immediate accretion to both our top- and bottom-lines.”
Strategic Rationale
- Strategically aligns with Collegium’s mission of building a leading, diversified specialty pharmaceutical company by broadening the commercial portfolio beyond pain management and establishing a commercial presence in neurology via the large and growing ADHD market.
- Jornay PM is poised to become Collegium’s leading growth driver. Net revenue for Jornay PM is expected to be in excess of $100 million in 2024. In the first half of 2024, Jornay PM prescriptions grew 32% year-over-year. For the full-year 2023, the product generated approximately 490,000 prescriptions, a 58% increase compared to 2022. Jornay PM is a highly differentiated treatment for ADHD due to its evening dosing, smooth therapeutic effect and dose-dependent duration.
- Jornay PM is supported by 16 Orange Book-listed patents, with expiries in 2032.
- Further strengthens Collegium’s financial position through an increased revenue base, expected immediate accretion to adjusted EBITDA and accelerated cash flow generation.
For additional background on the acquisition, please read the announcement press release here and view Collegium’s investor presentation here.
Additional Transaction Details
Under the terms of the agreement, Collegium acquired all the outstanding shares of Ironshore for $525 million in cash, which was funded by $200 million of Collegium’s existing cash on hand and $325 million of Collegium’s $646 million term loan provided by investment funds managed by Pharmakon Advisors, LP. Collegium will also pay Ironshore shareholders $25 million in additional consideration if Jornay PM net revenue exceeds a defined threshold in 2025. The balance of the $646 million five-year term loan was used to repay Collegium’s prior $320.8 million term loan, reducing Collegium’s interest rate by 300 basis points.
Financial Guidance for 2024
Collegium updates its full-year 2024 financial guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA, which includes four months of anticipated impact from the acquisition of Ironshore.
| Prior | Updated | |
| Product Revenues, Net | $580.0 to $595.0 million | $620.0 to $635.0 million |
| Adjusted Operating Expenses (Excluding Stock-Based Compensation) |
$120.0 to $125.0 million | $150.0 to $155.0 million |
| Adjusted EBITDA (Excluding Stock-Based Compensation) |
$380.0 to $395.0 million | $395.0 to $405.0 million |
About JORNAY PM®
JORNAY PM (methylphenidate HCl extended-release capsules) is a central nervous system (CNS) stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: ABUSE, MISUSE, AND ADDICTIONSee full prescribing information for complete boxed warning.
See additional important safety information below. |
CONTRAINDICATIONS
- Known hypersensitivity to methylphenidate or other components of JORNAY PM. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days because of the risk of hypertensive crisis.
WARNINGS AND PRECAUTIONS
JORNAY PM can cause serious adverse reactions and patients should be monitored for the following:
- Risks to Patients with Serious Cardiac Disease: Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
- Increased Blood Pressure and Heart Rate.
- Psychiatric Adverse Reactions: Including exacerbation of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder, induction of a manic episode in patients with bipolar disorder, and new psychotic or manic symptoms. Prior to initiating treatment, screen patients for risk factors for psychiatric adverse reactions. If such symptoms occur, consider discontinuing JORNAY PM.
- Priapism: Patients should seek immediate medical attention.
- Peripheral Vasculopathy, including Raynaud’s Phenomenon: Observe patients for digital changes during treatment.
- Weight Loss and Long-Term Suppression of Growth in Pediatric Patients: Monitor height and weight.
- Increased Intraocular Pressure (IOP) and Glaucoma: Patients at risk for acute angle closure glaucoma should be evaluated by an ophthalmologist. Closely monitor patients with a history of abnormally increased IOP or open angle glaucoma.
- Onset or Exacerbation of Motor and Verbal Tics, and Worsening of Tourette’s Syndrome.
ADVERSE REACTIONS
- The most common (≥5% and twice the rate of placebo) adverse reactions with methylphenidate are decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, decreased weight, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.
- Additional adverse reactions (≥5% and twice the rate of placebo) in JORNAY PM-treated pediatric patients 6 to 12 years are headache, psychomotor hyperactivity, and mood swings.
DRUG INTERACTIONS
- Antihypertensive drugs: Monitor blood pressure data. Adjust dosage of antihypertensive drug as needed.
About Collegium Pharmaceutical, Inc.
Collegium is a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit Collegium’s website at www.collegiumpharma.com.
