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
second quarter ended June 30, 2020 and provided a corporate
update.
“Collegium delivered strong financial results in the second
quarter of 2020, which is a testament to the resilience and
adaptability of our people and operations,” said Joe Ciaffoni,
President and Chief Executive Officer of Collegium. “We made
progress towards achieving each of our key business objectives,
while prioritizing the health and safety of our people, customers
and communities. Xtampza ER revenue growth and the impact of the
Nucynta acquisition generated meaningful cashflow from operations,
enabling us to begin to pay down debt, and setting the stage for
2020 to be a financially transformative year for Collegium.”
Recent Business Highlights
- Xtampza ER total prescriptions grew to 141,678 for the quarter
ended June 30, 2020 (the “2020 Quarter”), representing a 22%
increase over the quarter ended June 30, 2019 (the “2019 Quarter”)
and a 4% increase over the first quarter of 2020.
- Xtampza ER market share of the oxycodone extended-release
market was 23.5% in the 2020 Quarter, up from 21.8% in the first
quarter of 2020.
- In the 2020 Quarter, two new formulation patents covering
Xtampza ER were added to the FDA Orange Book, one with an expiry in
2030 and one with an expiry in 2036. With these recent additions to
the patent estate, Xtampza ER is now covered by 19 Orange
Book-listed patents.
- A manuscript describing certain real-world evidence with
respect to abuse, misuse, and diversion of Xtampza ER was recently
accepted for publication in Pain Medicine, the Journal of the
American Academy of Pain Medicine.
- Nucynta® ER market share of the branded extended-release market
grew to 6.2% in the 2020 Quarter, up from 6.1% in the first quarter
of 2020. This represents five consecutive quarters in which market
share was stable or growing.
Financial Results for Quarter Ended June 30,
2020
- Xtampza ER net product revenues were $33.6 million for the 2020
Quarter, compared to $26.0 million for the 2019 Quarter and $31.5
million for the quarter ended March 31, 2020, representing an
increase of 29% and 7%, respectively.
- Nucynta franchise net product revenues were $44.5 million in
the 2020 Quarter, compared to $49.0 million for the 2019 Quarter
and $45.0 million for the quarter ended March 31, 2020,
representing a decrease of 9% and 1%, respectively.
- Operating expenses were $31.8 million for the 2020 Quarter,
compared to $31.4 million for the 2019 Quarter.
- Net income for the 2020 Quarter was $8.1 million, or $0.23 per
share (basic and diluted), compared to net loss of $4.7 million, or
$0.14 loss per share (basic and diluted), for the 2019
Quarter.
- Non-GAAP adjusted income for the 2020 Quarter was $33.2
million, compared to a non-GAAP adjusted income of $3.1 million for
the 2019 Quarter.
Conference Call
Information
The Company will host a conference call and live audio webcast
on Wednesday, August 5, 2020 at 4:30 p.m. Eastern Time. To access
the conference call, please dial (877) 407-8037 (U.S.) or (201)
689-8037 (International) and reference the “Collegium Q2 Earnings
Call.” 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. 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 is not based on any standardized
methodology prescribed by GAAP and represents GAAP net income
adjusted to exclude stock-based compensation expense, amortization
expense, non-cash interest expense, certain royalty costs
recognized in connection with the Nucynta Commercialization
Agreement and the provision for income taxes. 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 income 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 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 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 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 June 30, 2020 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)
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Cash and cash equivalents |
|
$ |
145,678 |
|
|
170,019 |
Accounts receivable |
|
|
81,195 |
|
|
72,953 |
Inventory |
|
|
18,815 |
|
|
9,643 |
Prepaid expenses and other current assets |
|
|
5,125 |
|
|
3,105 |
Property and equipment, net |
|
|
15,156 |
|
|
11,854 |
Operating lease assets |
|
|
8,697 |
|
|
9,047 |
Intangible asset, net |
|
|
369,494 |
|
|
29,503 |
Restricted cash |
|
|
2,547 |
|
|
— |
Other noncurrent assets |
|
|
163 |
|
|
178 |
Total assets |
|
$ |
646,870 |
|
$ |
306,302 |
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
33,293 |
|
|
39,727 |
Accrued rebates, returns and discounts |
|
|
171,053 |
|
|
157,549 |
Term notes payable |
|
|
180,931 |
|
|
11,500 |
Convertible senior notes |
|
|
96,046 |
|
|
— |
Operating lease liabilities |
|
|
9,780 |
|
|
10,094 |
Stockholders’ equity |
|
|
155,767 |
|
|
87,432 |
Total liabilities and stockholders’ equity |
|
$ |
646,870 |
|
$ |
306,302 |
|
|
|
|
|
|
|
Collegium Pharmaceutical,
Inc.
Unaudited Condensed Statements of
Operations(in thousands, except share and per
share amounts)
|
Three months ended
June 30, |
|
Six months ended
June 30, |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Product revenues, net |
$ |
78,058 |
|
|
$ |
75,040 |
|
|
$ |
154,569 |
|
|
$ |
149,556 |
|
Cost of product revenues |
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (excluding intangible asset
amortization) |
|
12,899 |
|
|
|
44,966 |
|
|
|
40,128 |
|
|
|
90,442 |
|
Intangible asset amortization |
|
16,795 |
|
|
|
3,688 |
|
|
|
27,090 |
|
|
|
7,376 |
|
Total cost of products
revenues |
|
29,694 |
|
|
|
48,654 |
|
|
|
67,218 |
|
|
|
97,818 |
|
Gross profit |
|
48,364 |
|
|
|
26,386 |
|
|
|
87,351 |
|
|
|
51,738 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
2,493 |
|
|
|
2,459 |
|
|
|
5,159 |
|
|
|
5,451 |
|
Selling, general and administrative |
|
29,322 |
|
|
|
28,935 |
|
|
|
60,582 |
|
|
|
61,287 |
|
Total operating expenses |
|
31,815 |
|
|
|
31,394 |
|
|
|
65,741 |
|
|
|
66,738 |
|
Income (loss) from
operations |
|
16,549 |
|
|
|
(5,008 |
) |
|
|
21,610 |
|
|
|
(15,000 |
) |
Interest expense |
|
(8,259 |
) |
|
|
(236 |
) |
|
|
(13,082 |
) |
|
|
(470 |
) |
Interest income |
|
14 |
|
|
|
532 |
|
|
|
226 |
|
|
|
1,058 |
|
Income (loss) before income
taxes |
|
8,304 |
|
|
|
(4,712 |
) |
|
|
8,754 |
|
|
|
(14,412 |
) |
Provision for income taxes |
|
246 |
|
|
|
— |
|
|
|
246 |
|
|
|
— |
|
Net income (loss) |
$ |
8,058 |
|
|
$ |
(4,712 |
) |
|
$ |
8,508 |
|
|
$ |
(14,412 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share —
basic |
$ |
0.23 |
|
|
$ |
(0.14 |
) |
|
$ |
0.25 |
|
|
$ |
(0.43 |
) |
Weighted-average shares —
basic |
|
34,395,266 |
|
|
|
33,397,709 |
|
|
|
34,247,977 |
|
|
|
33,338,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share —
diluted |
$ |
0.23 |
|
|
$ |
(0.14 |
) |
|
$ |
0.24 |
|
|
$ |
(0.43 |
) |
Weighted-average shares —
diluted |
|
35,091,906 |
|
|
|
33,397,709 |
|
|
|
35,089,740 |
|
|
|
33,338,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collegium Pharmaceutical,
Inc.
Reconciliation of GAAP to
Non-GAAP Financial Information(in thousands,
except per share amounts)(unaudited)
|
Three months ended |
|
Six
Months Ended |
|
June 30, |
|
June 30, |
|
2020 |
|
2019 |
|
|
2020 |
|
2019 |
|
GAAP net income (loss) |
$ |
8,058 |
|
$ |
(4,712 |
) |
|
$ |
8,508 |
|
$ |
(14,412 |
) |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense(1) |
|
5,584 |
|
|
4,162 |
|
|
|
10,535 |
|
|
8,425 |
|
Intangible asset amortization(2) |
|
16,795 |
|
|
3,688 |
|
|
|
27,090 |
|
|
7,376 |
|
Non-cash interest expense(3) |
|
2,524 |
|
|
— |
|
|
|
3,860 |
|
|
— |
|
Nucynta royalty adjustment (4) |
|
— |
|
|
— |
|
|
|
14,216 |
|
|
— |
|
Provision for income taxes (5) |
|
246 |
|
|
— |
|
|
|
246 |
|
|
— |
|
Total non-GAAP adjustments |
$ |
25,149 |
|
$ |
7,850 |
|
|
$ |
55,947 |
|
$ |
15,801 |
|
Non-GAAP adjusted income |
$ |
33,207 |
|
$ |
3,138 |
|
|
$ |
64,455 |
|
$ |
1,389 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 non-recurring 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.(5) Represents
current provision for estimated income taxes.
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