Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty
pharmaceutical company committed to being the leader in responsible
pain management, today reported its financial results for the first
quarter ended March 31, 2020 and provided a corporate
update.
“The COVID-19 pandemic presents complex challenges to
individuals, organizations and communities across the world. At
Collegium, we are committed to keeping our employees safe, reliably
supplying our medicines and supporting our customers and the
communities we serve,” said Joe Ciaffoni, President and Chief
Executive Officer of Collegium. “Despite the unprecedented times we
all face, we continue to make progress towards our mission of
becoming the leader in responsible pain management. I am honored
and humbled to work alongside our dedicated employees who are
committed to making a difference in the lives of people suffering
from pain.”
“In the first quarter of 2020 Collegium achieved profitability,
driven by Xtampza ER revenue growth and the closing of the Nucynta
franchise acquisition,” commented Paul Brannelly, Executive Vice
President and Chief Financial Officer of Collegium. “Despite the
impacts of COVID-19, we expect 2020 will be financially
transformative for Collegium, with a focus on profitability, cash
generation and debt repayment.”
Recent Business Highlights
- Xtampza ER total prescriptions grew to 136,736 for the quarter
ended March 31, 2020 (the “2020 Quarter”), representing a 30%
increase over the quarter ended March 31, 2019 (the “2019 Quarter”)
and a 10.2% increase over the fourth quarter of 2019.
- Xtampza ER market share of the oxycodone extended-release
market was 21.8% in the 2020 Quarter, up from 18.5% in the fourth
quarter of 2019.
- The number of unique prescribers grew to 14,600 in the 2020
Quarter, a 9.5% increase over the fourth quarter of 2019.
- In the 2020 Quarter, two new patents covering Xtampza ER were
added to the FDA Orange Book. With these recent additions to the
patent estate, Xtampza ER is now covered by 17 Orange Book listed
patents.
- The Company saw strong volume and market share growth in the 20
new exclusive ER oxycodone formulary wins, covering more than 35
million lives for Xtampza ER, that took effect January 1,
2020. Collegium is the exclusive ER oxycodone for approximately 40%
of Commercial and Part D covered lives. Xtampza ER continues to
have broad-based coverage, including 95% coverage of Commercial
lives and 50% coverage of Part D lives.
- Nucynta® ER market share of the branded extended-release market
grew to 6.1% in the 2020 Quarter, up from 5.8% in the fourth
quarter of 2019. This represents four consecutive quarters in which
market share grew or was stable.
- On February 13, 2020, the Company closed the acquisition of
the U.S. rights to the Nucynta Franchise from Assertio
Therapeutics, Inc.
Financial Guidance for
2020
The Company updates its full-year 2020 financial guidance:
|
|
|
|
Prior |
Updated |
|
|
|
Xtampza ER Revenues |
$150.0 to $160.0 million |
$130.0 to $140.0 million |
|
|
|
Nucynta Franchise Revenues |
$170.0 to $180.0 million |
Unchanged |
|
|
|
Total Operating Expenses |
$130.0 to $140.0 million |
$120.0 to $130.0 million |
|
|
|
Non-GAAP Adjusted Income |
$125.0 to $140.0 million |
$125.0 to $135.0 million |
Financial Results for Quarter Ended March 31,
2020
- Xtampza ER net product revenues were $31.5 million for the 2020
Quarter, compared to $25.1 million for the 2019 Quarter and $27.4
million for the quarter ended December 31, 2019,
representing an increase of 25% and 15%, respectively.
- Nucynta franchise net product revenues were $45.0 million in
the 2020 Quarter, compared to $49.4 million for the 2019 Quarter
and $46.8 million for the quarter ended December 31, 2019,
representing a decrease of 9% and 4%, respectively.
- Operating expenses were $33.9 million for the 2020 Quarter,
compared to $35.3 million for the 2019 Quarter.
- Net income for the 2020 Quarter was $0.5 Million, or $0.01 per
share (basic and diluted), compared to net loss of $9.7 million, or
$0.29 loss per share (basic and diluted), for the 2019 Quarter. In
the 2020 Quarter, in relation to the accounting treatment of the
Nucynta Acquisition, net income includes a one-time expense of
$14.2 million for royalties that would have been owed under the
prior Nucynta commercialization agreement.
- Non-GAAP adjusted income for the 2020 Quarter was $31.2
million, compared to a non-GAAP adjusted loss of $1.7 million for
the 2019 Quarter.
Collegium’s Response to
COVID-19
In response to the ongoing COVID-19 pandemic, and in an effort
to ensure the health and wellbeing of our employees, customers,
stakeholders and communities, the Company has taken the following
actions:
- Implemented a mandatory work-from-home policy for the entire
organization, including our home-office and field-based
employees.
- Created a cross-functional pandemic planning team focused on
ensuring the health and well-being of our employees and customers
and ensuring preparedness plans for when we resume in-person
activities.
- Confirmed the stability of our supply chain and worked with our
manufacturing partners to ensure strong business continuity
plans.
- Donated $240,000 to support community response efforts,
including $40,000 which was raised through the Company’s employer
match program.
Conference Call
Information
The Company will host a conference call and live audio webcast
on Thursday, May 7, 2020 at 4:30 p.m. Eastern Time. To access the
conference call, please dial (888) 698-6931 (U.S.) or (805)
905-2993 (International) and refer to Conference ID: 358-1447. An
audio webcast will be accessible from the Investors section of the
Company’s website: www.collegiumpharma.com. The webcast will be
available for replay on the Company’s website approximately two
hours after the event.
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.
Non-GAAP Financial
Measures
To supplement our financial results presented on a GAAP basis,
we have included information about non-GAAP adjusted income (loss).
We 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 and the accompanying
reconciliation, 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 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.
Non-GAAP adjusted income (loss) is not based on any standardized
methodology prescribed by GAAP and represents GAAP net income
(loss) adjusted to exclude stock-based compensation expense,
amortization expense, non-cash interest expense, and certain
royalty costs recognized in connection with the Nucynta
Commercialization Agreement. 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. Please
see the section of this press release titled “Reconciliation of
GAAP to Non-GAAP Financial Information” for a reconciliation of
non-GAAP adjusted loss to its most directly comparable GAAP
measure.
The Company has not provided a reconciliation of its full-year
2020 guidance for non-GAAP adjusted income (loss) to the most
directly comparable forward-looking GAAP measure because it is
unable to predict, without unreasonable efforts, the timing and
amount of items that would be included such a reconciliation. These
items are uncertain and depend on various factors that could have a
material impact on GAAP net income (loss) for the guidance
period.
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 the impact of the COVID-19 pandemic on our
ability to conduct our business, reach our customers, and supply
the market with our products; our expectations related to the
potential impact of the Nucynta acquisition 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
Annual Report on Form 10-K for the year ended December 31, 2019 and
other filings 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.
Contact:Alex Dasallaadasalla@collegiumpharma.com
Collegium Pharmaceutical,
Inc.
Unaudited Selected Consolidated
Balance Sheet Information(in thousands)
|
March 31, |
|
December 31, |
|
2020 |
|
2019 |
Cash and cash
equivalents |
$ |
116,178 |
|
$ |
170,019 |
Accounts receivable |
|
85,427 |
|
|
72,953 |
Inventory |
|
15,963 |
|
|
9,643 |
Prepaid expenses and other current assets |
|
6,107 |
|
|
3,105 |
Property and equipment, net |
|
13,145 |
|
|
11,854 |
Operating lease assets |
|
8,873 |
|
|
9,047 |
Intangible asset, net |
|
386,289 |
|
|
29,503 |
Restricted cash |
|
2,645 |
|
|
— |
Other noncurrent assets |
|
166 |
|
|
178 |
Total assets |
$ |
634,793 |
|
$ |
306,302 |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
24,953 |
|
|
39,727 |
Accrued rebates, returns and discounts |
|
171,886 |
|
|
157,549 |
Term notes payable |
|
192,570 |
|
|
11,500 |
Convertible senior notes |
|
94,383 |
|
|
— |
Operating lease liabilities |
|
9,938 |
|
|
10,094 |
Stockholders’ equity |
|
141,063 |
|
|
87,432 |
Total liabilities and stockholders’ equity |
$ |
634,793 |
|
$ |
306,302 |
Collegium Pharmaceutical,
Inc.
Unaudited Condensed Statements of
Operations(in thousands, except share and per
share amounts)
|
Three months ended
March 31, |
|
2020 |
|
2019 |
Product revenues, net |
$ |
76,511 |
|
|
$ |
74,516 |
|
Cost of product revenues |
|
|
|
|
|
Cost of product revenues (excluding intangible asset
amortization) |
|
27,229 |
|
|
|
45,476 |
|
Intangible asset amortization |
|
10,295 |
|
|
|
3,688 |
|
Total cost of products
revenues |
|
37,524 |
|
|
|
49,164 |
|
Gross profit |
|
38,987 |
|
|
|
25,352 |
|
Operating expenses |
|
|
|
|
|
Research and development |
|
2,666 |
|
|
|
2,992 |
|
Selling, general and administrative |
|
31,260 |
|
|
|
32,352 |
|
Total operating expenses |
|
33,926 |
|
|
|
35,344 |
|
Income (loss) from
operations |
|
5,061 |
|
|
|
(9,992 |
) |
Interest expense |
|
(4,823 |
) |
|
|
(234 |
) |
Interest income |
|
212 |
|
|
|
526 |
|
Net income (loss) |
$ |
450 |
|
|
$ |
(9,700 |
) |
|
|
|
|
|
|
Earnings (loss) per share —
basic |
$ |
0.01 |
|
|
$ |
(0.29 |
) |
Weighted-average shares —
basic |
|
34,100,688 |
|
|
|
33,331,917 |
|
|
|
|
|
|
|
Earnings (loss) per share —
diluted |
$ |
0.01 |
|
|
$ |
(0.29 |
) |
Weighted-average shares —
diluted |
|
35,069,693 |
|
|
|
33,331,917 |
|
Collegium Pharmaceutical,
Inc.
Reconciliation of GAAP to
Non-GAAP Financial Information(in thousands,
except per share amounts)(unaudited)
|
|
|
|
|
|
|
Three months ended |
|
March 31, |
|
2020 |
|
2019 |
GAAP net income (loss) |
$ |
450 |
|
$ |
(9,700 |
) |
Non-GAAP adjustments: |
|
|
|
|
|
Stock-based compensation expense(1) |
|
4,951 |
|
|
4,263 |
|
Intangible asset amortization(2) |
|
10,295 |
|
|
3,688 |
|
Non-cash interest expense(3) |
|
1,336 |
|
|
— |
|
Nucynta royalty adjustment(4) |
|
14,216 |
|
|
— |
|
Total non-GAAP adjustments |
$ |
30,798 |
|
$ |
7,951 |
|
Non-GAAP adjusted income
(loss) |
$ |
31,248 |
|
$ |
(1,749 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
Second Quarter |
|
Third Quarter |
|
Fourth Quarter |
|
2019 |
|
2019 |
|
2019 |
|
2019 |
GAAP net loss |
$ |
(9,700 |
) |
|
$ |
(4,712 |
) |
|
$ |
(6,109 |
) |
|
$ |
(2,201 |
) |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense(1) |
|
4,263 |
|
|
|
4,162 |
|
|
|
4,137 |
|
|
|
3,966 |
|
Intangible asset amortization(2) |
|
3,688 |
|
|
|
3,688 |
|
|
|
3,688 |
|
|
|
3,688 |
|
Total non-GAAP adjustments |
$ |
7,951 |
|
|
$ |
7,850 |
|
|
$ |
7,825 |
|
|
$ |
7,654 |
|
Non-GAAP adjusted income
(loss) |
$ |
(1,749 |
) |
|
$ |
3,138 |
|
|
$ |
1,716 |
|
|
$ |
5,453 |
|
(1) Represents stock-based compensation expense associated with
our stock option, restricted stock unit and performance stock unit
grants and our employee share purchase plan. (2) Represents
amortization expense from the Nucynta Intangible Asset.(3)
Represents non-cash interest expense recognized related to the
accretion of debt discount and amortization of debt issuance
costs.(4) Represents adjustment for royalty expense recognized in
2020 prior to the closing of the Nucynta Asset Purchase Agreement
in February 2020. The royalty expense was included as a reduction
to the base purchase price for the Nucynta Asset Purchase Agreement
and, upon closing, the Company was discharged of any unpaid
royalties due to Assertio.
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