COLLMEDIUM SIGNALREGULATORY10-K

Collegium Pharmaceutical faces new generic competition with FDA approval of generic Nucynta IR in three dosage strengths, while entering an authorized generic agreement with Hikma.

The approval of generic Nucynta IR represents a significant competitive threat to one of COLL's key revenue drivers, though the generic excludes pediatric use which may preserve some market exclusivity. The authorized generic agreement with Hikma suggests management is proactively positioning to maintain market share through a controlled generic launch rather than losing revenue entirely to third-party generics.

Comparing 2026-02-26 vs 2025-02-27View on EDGAR →
FINANCIAL ANALYSIS

COLL demonstrated strong operational performance with revenue growing 23.6% to $780.6M and operating cash flow substantially higher at $329.3M. The company strengthened its balance sheet position with current assets expanding 43.4% to $691.4M and stockholders' equity increasing 31.8%, while reducing current liabilities by 13.6%. Higher SG&A expenses of $284.8M and increased interest expense of $83.3M reflect continued investment in growth, though the company reduced share buybacks to $25.1M from $60.0M.

FINANCIAL STATEMENT CHANGES
Operating Cash Flow
Cash Flow
+60.7%
$205.0M→$329.3M

Operating cash flow surged 60.7% — exceptional cash generation, highest quality earnings signal.

Share Buybacks
Cash Flow
-58.2%
$60.0M→$25.1M

Buyback activity reduced 58.2% — capital being redeployed elsewhere or cash conservation underway.

Current Assets
Balance Sheet
+43.4%
$482.3M→$691.4M

Current assets grew 43.4% — improving short-term liquidity or inventory/receivables build.

SG&A Expense
P&L
+35.4%
$210.4M→$284.8M

SG&A up 35.4% — significant increase in sales or administrative costs, monitor impact on operating leverage.

Interest Expense
P&L
+31.8%
$63.2M→$83.3M

Interest expense surged 31.8% — significant debt increase or rising rates materially impacting earnings.

Stockholders Equity
Balance Sheet
+31.8%
$228.8M→$301.7M

Equity base grew 31.8% — retained earnings accumulation or equity issuance strengthening the balance sheet.

Revenue
P&L
+23.6%
$631.4M→$780.6M

Revenue growing 23.6% — solid top-line momentum, watch margins for quality of growth.

Gross Profit
P&L
+22.8%
$377.3M→$463.3M

Gross profit expanding — improving pricing power or product mix shift toward higher-margin offerings.

Inventory
Balance Sheet
+15.1%
$35.6M→$40.9M

Inventory built 15.1% — monitor whether demand supports this build or if write-downs may follow.

Current Liabilities
Balance Sheet
-13.6%
$509.5M→$440.0M

Current liabilities reduced — improved short-term financial position and working capital health.

LANGUAGE CHANGES
NEW — 2026-02-26
PRIOR — 2025-02-27
ADDED
As of January 31, 2026, there were 31,753,211 shares of the registrant's common stock, par value, $0.001 per share, outstanding.
We commercialize our products, consisting of Jornay PM, Belbuca, Xtampza ER, Nucynta ER and Nucynta IR (collectively the Nucynta Products ), and Symproic, in the United States.
Therefore, we plan to continue monitoring real world data characterizing the rate of abuse, misuse, and diversion of Xtampza ER.
We have entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc.
( Hikma ), pursuant to which we granted Hikma rights relating to an authorized generic version of the Nucynta Products in the United States.
In January 2026, a generic equivalent of Nucynta IR 50mg, 75mg and 100mg tablets was approved under an abbreviated New Drug Application ( ANDA ) filed by a third party with the FDA, which carves out pediatric use from its label.
As a result of the anticipated launch of the third-party generic equivalent of Nucynta IR, Hikma launched a generic version of Nucynta IR on February 25, 2026.
Hikma is expected to launch a generic version of Nucynta ER in the first quarter of 2026.
In 2022 2023, approximately 11.4% of children or 7.1 million aged 3 17 and 6% of adults or 15.5 million had a current diagnosis of ADHD in the United States.
In 2021, the economic costs of chronic pain in the United States were estimated to be $722.8 billion, including $530.6 billion in medical care costs and $192.2 billion in lost work productivity, which does not include the cost of care for institutionalized individuals (e.g., nursing home residents, prisoners), military personnel, or children, or the costs associated with caregiving.
REMOVED
As of January 31, 2025, there were 31,485,523 shares of the registrant's common stock, par value, $0.001 per share, outstanding.
These and other risks are described under the heading Risk Factors in this Annual Report on Form 10-K.
We commercialize our products, consisting of Jornay PM ( Jornay ), Belbuca, Xtampza ER ( Xtampza ), Nucynta ER and Nucynta IR (collectively the Nucynta Products ), and Symproic, in the United States.
Therefore, we plan to continue monitoring real world data characterizing the rate of abuse, misuse, and diversion of Xtampza.
Nucynta Products The Nucynta Products are extended-release ( ER ) and immediate-release ( IR ) oral formulations of tapentadol, a Schedule II opioid.
In the United States, it is estimated that 10.5% or 6.5 million children and 6.0% or 15.5 million adults have a current diagnosis of ADHD.
Pain, Pain Management, and Opioid Abuse in the United States Acute and Chronic Pain Pain can be classified along many different variables, including severity, duration and etiology.
A 2011 report from the Institute of Medicine estimated that chronic pain costs the U.S.
between $560.0 and $635.0 billion per year in direct medical costs and lost productivity, which does not include the cost of care for institutionalized individuals (e.g., nursing home residents, prisoners), military personnel, or children, or the costs associated with caregiving.
In 2024, there were approximately 136.3 million prescriptions for opioids written in the United States, representing a 2.5% decline from 2023 levels and including approximately 10.2 million prescriptions for long-acting/extended-release opioids, and approximately 126.1 million prescriptions for immediate-release opioids.
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