Full Press Release Details
Collegium to Acquire U.S. Rights to Nucynta
- Financially Transformative Acquisition
- Expected to Significantly Grow
Net Income, EBITDA and Operating Cash Flows -
- Structure of the Financing Allows
for Rapid De-Leveraging -
- Provides Financial Flexibility
to Pursue Future Business Development Transactions -
STOUGHTON, Mass., Feb. 6, 2020 -- Collegium Pharmaceutical,
Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today
announced that it has entered into a definitive agreement to acquire the U.S. rights to the Nucynta Franchise from Assertio Therapeutics,
Inc. ("Assertio") for $375.0 million in cash.
"Acquiring the full U.S. rights to the Nucynta Franchise
is financially transformative for Collegium," said Joe Ciaffoni, President and Chief Executive Officer of Collegium. "We
expect the acquisition to improve annual EBITDA and operating cash flows by more than $100 million. The transaction is supported
by a financing structure that allows for rapid de-leveraging and enables us to pursue future business development transactions."
The Nucynta Franchise
Financial Guidance for 2020
Collegium reiterates its full-year 2020 financial guidance,
initially provided on January 7, 2020:
Jefferies LLC acted as financial advisor to Collegium on the
transaction, and Pepper Hamilton LLP served as legal counsel.
About Collegium Pharmaceutical, Inc.
Collegium is a specialty pharmaceutical company committed to
being the leader in responsible pain management. Collegium's headquarters are located in Stoughton, Massachusetts. For more
information, please visit the company's website at www.collegiumpharma.com.
Xtampza ER is Collegium's first product
utilizing the DETERx technology platform. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved
by the FDA for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate.
Nucynta ER is an extended-release formulation
of tapentadol. Tapentadol is a centrally acting synthetic analgesic. Nucynta ER is approved by the FDA for the management of pain
severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Nucynta ER is also approved by the FDA for neuropathic pain associated with diabetic peripheral neuropathy severe enough to require
daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Nucynta is an immediate release formulation
of tapentadol indicated for the management of acute pain severe enough to require an opioid analgesic. Tapentadol is a centrally
acting synthetic analgesic.
Non-GAAP Financial Measures
To supplement our financial results presented on a GAAP basis,
we have included information about EBITDA. We internally use this non-GAAP financial measure to understand, manage and evaluate
the Company as we believe it represents the performance of our core business. Because this non-GAAP financial measure is an important
internal measure for the Company, we believe that the presentation of the non-GAAP financial measure provides analysts, investors
and lenders insight into management's view and assessment of the Company's ongoing operating performance. In addition,
we believe that the presentation of this non-GAAP financial measure, when viewed with our results under GAAP, provides supplementary
information that may be useful to analysts, investors, lenders, and other third parties in assessing the Company's performance
and results from period to period. We report this non-GAAP financial measure in order to portray the results of our major operations
- commercializing innovative, differentiated products for people suffering from pain - prior to considering certain
income statement elements. This non-GAAP financial measure should be considered in addition to, and not a substitute for, or superior
to, net income or other financial measures calculated in accordance with GAAP. The Non-GAAP financial measure is not based on any
standardized methodology prescribed by GAAP and represents GAAP net income (loss) before interest expense, interest income, income
tax expense, depreciation expense and amortization expense. Any non-GAAP financial measures used by us may be calculated differently
from, and therefore may not be comparable to, a non-GAAP measure used by other companies.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts,"
"forecasts," "believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could," "might,"
"should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.
Examples of forward-looking statements contained in this press release include, among others, statements regarding financial guidance
for Xtampza ER and Nucynta Franchise revenues, total operating expenses, current and future market opportunities for our products
and our assumptions related thereto. Such statements are subject to numerous important factors, risks and uncertainties that may
cause actual events or results, performance, or achievements to differ materially from the company's current expectations. Management's
expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties
relating to a number of other factors, including our expectations related to the consummation of the acquisition of the Nucynta
assets and the potential impact on our future operating results; our ability to commercialize and grow sales of our products; our
ability to manage our relationships with licensors; the success of competing products that are or become available; our ability
to obtain and maintain regulatory approval of our products and any product candidates, and any related restrictions, limitations,
and/or warnings in the label of an approved product; the size of the markets for our products and product candidates, and our ability
to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree
of market acceptance of our products and product candidates; the costs of commercialization activities, including marketing, sales
and distribution; changing market conditions for our products; the outcome of any patent infringement, opioid-related or other
litigation that may be brought by or against us, including litigation with Purdue Pharma, L.P. and Teva Pharmaceuticals USA, Inc.;
the outcome of any governmental investigation related to the manufacture, marketing and sale of opioid medications; our ability
to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially
saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.;
our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our
ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including
U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; and the accuracy of our estimates regarding expenses,
revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk
Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, and in other reports which we file
with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release.
We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise,
after the date of this press release.
Reconciliation of GAAP to Non-GAAP Financial Information
| Illustrative Pro Forma | ||||||||
| Annualized (1) | ||||||||
| Nine Months Ended | Twelve Months Ended | |||||||
| September 30, | December 31, | |||||||
| 2019 | 2019 | |||||||
| GAAP net loss | $ | (20,521 | ) | $ | (27,361 | ) | ||
| EBITDA adjustments: | ||||||||
| Interest expense | 698 | 931 | ||||||
| Interest income | (1,552 | ) | (2,069 | ) | ||||
| Depreciation expense | 535 | 713 | ||||||
| Amortization expense | 11,064 | 14,752 | ||||||
| Total EBITDA adjustments | $ | 10,745 | $ | 14,327 | ||||
| EBITDA | $ | (9,776 | ) | $ | (13,034 | ) | ||
| Illustrative Pro Forma Adjustments | ||||||||
| Nucynta royalties due to Assertio (2) | 94,163 | 118,842 | ||||||
| Nucynta royalties due to Grunenthal (3) | - | 6,958 | ||||||
| Total Illustrative Pro Forma Adjustments | $ | 94,163 | $ | 125,800 | ||||
| Illustrative Pro Forma EBITDA | $ | 84,387 | $ | 112,766 | ||||
| Change in EBITDA | $ | 94,163 | $ | 125,800 |
(1) Represents illustrative pro forma
annualized GAAP net loss, interest expense, interest income, depreciation expense, and amortization expense based on annualizing
the amounts disclosed for the nine months ended September 30, 2019 in the Condensed Consolidated Financial Statements as filed
on Form 10-Q for the period ending September 30, 2019.
(2) Represents calculated royalties
due to Assertio under the Third Amendment to the Nucynta Commercialization Agreement, which are no longer required under the agreement
to acquire the Nucynta Franchise. For the nine months ended September 30, 2019, the Company recognized product revenues, net from
the Nucynta Products of $144,866, which results in $94,163 of calculated royalties due to Assertio (65% of net product revenues
from the Nucynta Products). The Company's illustrative pro forma annualized product revenues, net from the Nucynta Products
is $193,155, which results in $118,842 of calculated royalties due to Assertio (65% of net product revenues up to $180,000, or
$117,000, plus 14% of net product revenues from $180,000 to $193,155, or $1,842, for total calculated royalties due of $118,842).
(3) Represents the change in calculated
royalties due to Grunenthal under the agreement to acquire the Nucynta Franchise compared to the Third Amendment to the Nucynta