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Collegium Reports Third Quarter 2019 Financial Results

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– New Exclusive Formulary Wins Announced for Xtampza® ER Effective January 1, 2020 Covering More than 35 Million Lives –

– Xtampza® ER Net Product Revenues Were $26.5 Million in the Third Quarter of 2019, a 56% Increase Over the Third Quarter of 2018 –

– Cash Increased by $5.1 Million, to $153.8 Million as of September 30, 2019 –

– Conference Call Scheduled for Today at 4:30 p.m. ET –

STOUGHTON, Mass., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2019 and provided a corporate update.

“Driven by strong Xtampza ER revenue growth and a commitment to leveraging our existing cost structure, we are on track to make 2019 a breakthrough year for Collegium,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “Effective January 1, 2020, Xtampza ER will become the exclusive extended-release oxycodone for more than 35 million additional lives. These payer wins will drive the next stage of growth for Xtampza ER.”

Recent Business Highlights

  • Xtampza ER formulary access continues to strengthen: As of January 1, 2020, Xtampza ER will move into an exclusive formulary position across 15 plans covering more than 35 million lives. With the addition of these new exclusive ER oxycodone formulary positions, Xtampza ER will be the exclusive branded ER oxycodone for more than 85 million lives.

  • Xtampza ER total prescriptions grew to 120,409 in the third quarter of 2019. Through the first three quarters of 2019, prescriptions grew 44% over the prior year period, and 3% compared to the second quarter of 2019.

  • Strengthened management team with the appointment of Bart Dunn to the role of Executive Vice President, Strategy and Corporate Development.

Leading with the Science

  • Collegium had a strong presence at the 13th Annual PAINWeek National Conference which took place in Las Vegas in September 2019. Four poster presentations that span Collegium’s product portfolio were presented during the conference.

  • A manuscript about Nucynta ER titled, “Evaluation of Abuse and Route of Administration of Extended-Release Tapentadol Among Treatment-Seeking Individuals, as Captured by the Addiction Severity Index–Multimedia Version (ASI-MV)” was recently published in the online journal Pain Medicine.

Financial Results for Quarter Ended September 30, 2019

  • Xtampza ER net product revenues were $26.5 million for the quarter ended September 30, 2019 (the “2019 Quarter”), compared to $17.0 million for the quarter ended September 30, 2018 (the “2018 Quarter”) and $26.0 million for the quarter ended June 30, 2019, representing an increase of 56% and 2%, respectively.

  • Nucynta franchise net product revenues were $46.4 million in the 2019 Quarter, compared to $53.1 million for the 2018 Quarter and $49.0 million for the quarter ended June 30, 2019, representing a decrease of 13% and 5%, respectively.

  • Selling, general and administrative expenses were $30.1 million for the 2019 Quarter, compared to $33.4 million for the 2018 Quarter.

  • Net loss for the 2019 Quarter was $6.1 million, or $0.18 per share (basic and diluted), compared to net loss of $16.5 million, or $0.50 per share (basic and diluted), for the 2018 Quarter. Net loss included stock-based compensation expense of $4.1 million and $3.9 million for the 2019 Quarter and 2018 Quarter, respectively.

  • Non-GAAP adjusted income for the 2019 Quarter was $1.7 million, compared to a non-GAAP adjusted loss of $8.3 million for the 2018 Quarter.

  • Collegium had cash and cash equivalents of $153.8 million as of September 30, 2019, an increase of $5.1 million compared to the second quarter of 2019. The increase in cash and cash equivalents was primarily the result of cash provided by operating activities, partially offset by capital expenditures related to the buildout of additional manufacturing capacity.

Conference Call Information

Collegium will host a conference call and live audio webcast on Wednesday, November 6, 2019 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: 958-8674. 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 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 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 – 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 adjusted to exclude stock-based compensation expense, amortization expense for the Nucynta intangible asset, non-cash interest expense recognized on the Nucynta minimum royalty payments, and minimum royalty payments due and payable 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.

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. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results 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 ability to obtain and maintain regulatory approval of our products and product candidates; our ability to effectively commercialize in-licensed products and manage our relationships with licensors; the success of competing products that are or become available; 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 outcome of any patent infringement 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 product candidates and manufacture adequate supplies of 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; 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.

Contact:
Alex Dasalla
adasalla@collegiumpharma.com

Collegium Pharmaceutical, Inc.

Unaudited Selected Consolidated Balance Sheet Information

(in thousands)

September 30,

December 31,

2019

2018

Cash and cash equivalents

$

153,838

$

146,633

Accounts receivable

84,380

77,946

Inventory

8,760

7,817

Prepaid expenses and other current assets

2,807

5,116

Property and equipment, net

11,579

9,274

Operating lease assets

9,219

Intangible assets, net

33,191

44,255

Other noncurrent assets

204

204

Total assets

$

303,978

$

291,245

Accounts payable and accrued expenses

$

32,595

$

42,701

Accrued rebates, returns and discounts

165,263

144,783

Term loan payable

11,500

11,500

Operating lease liabilities

10,362

Other noncurrent liabilities

676

Stockholders’ equity

84,258

91,585

Total liabilities and stockholders’ equity

$

303,978

$

291,245

Collegium Pharmaceutical, Inc.

Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)

Three months ended
September 30,

Nine months ended
September 30

2019

2018

2019

2018

Product revenues, net

$

72,942

$

70,176

$

222,498

$

206,986

Costs and expenses:

Cost of product revenues

46,754

46,007

144,572

135,951

Research and development

2,491

1,907

7,942

6,412

Selling, general and administrative

30,072

33,448

91,359

96,309

Total costs and expenses

79,317

81,362

243,873

238,672

Loss from operations

(6,375

)

(11,186

)

(21,375

)

(31,686

)

Interest expense

(228

)

(5,868

)

(698

)

(17,726

)

Interest income

494

552

1,552

1,198

Net loss

$

(6,109

)

$

(16,502

)

$

(20,521

)

$

(48,214

)

Loss per share–basic and diluted

$

(0.18

)

$

(0.50

)

$

(0.62

)

$

(1.46

)

Weighted-average shares -basic and diluted

33,481,923

33,012,174

33,360,272

32,950,584


Reconciliation of GAAP to Non-GAAP Financial Information

(in thousands, except per share amounts)

(unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2019

2018

2019

2018

GAAP net loss

$

(6,109

)

$

(16,502

)

$

(20,521

)

$

(48,214

)

Non-GAAP adjustments:

Stock-based compensation expense

4,137

3,926

12,562

10,180

Nucynta related amortization expense (1)

3,688

32,407

11,064

94,340

Nucynta non-cash interest expense (2)

5,641

17,112

Nucynta minimum royalty payment due (3)

(33,750

)

(98,250

)

Total non-GAAP adjustments

$

7,825

$

8,224

$

23,626

$

23,382

Non-GAAP adjusted income (loss)

$

1,716

$

(8,278

)

$

3,105

$

(24,832

)

First Quarter

Second Quarter

Third Quarter

2019

2019

2019

GAAP net loss

$

(9,700

)

$

(4,712

)

$

(6,109

)

Non-GAAP adjustments:

Stock-based compensation expense

4,263

4,162

4,137

Nucynta related amortization expense (1)

3,688

3,688

3,688

Nucynta non-cash interest expense (2)

Nucynta minimum royalty payment due (3)

Total non-GAAP adjustments

$

7,951

$

7,850

$

7,825

Non-GAAP adjusted income (loss)

$

(1,749

)

$

3,138

$

1,716


First Quarter

Second Quarter

Third Quarter

Fourth Quarter

2018

2018

2018

2018

GAAP net income (loss)

$

(18,652

)

$

(13,060

)

$

(16,502

)

$

9,086

Non-GAAP adjustments:

Stock-based compensation expense

2,728

3,526

3,926

3,598

Nucynta related amortization expense (1)

29,526

32,407

32,407

15,494

Nucynta non-cash interest expense (2)

5,528

5,943

5,641

2,169

Nucynta minimum royalty payment due (3)

(30,750

)

(33,750

)

(33,750

)

(33,750

)

Total non-GAAP adjustments

$

7,032

$

8,126

$

8,224

$

(12,489

)

Non-GAAP adjusted loss

$

(11,620

)

$

(4,934

)

$

(8,278

)

$

(3,403

)

(1) Represents amortization expense of the Nucynta Intangible Asset.

(2) Represents non-cash interest expense associated with the minimum royalty payments of the Nucynta Commercialization Agreement.

(3) Represents minimum royalty payment due and payable in connection with the Nucynta Commercialization Agreement.