0001005201-19-000087.txt : 20190807 0001005201-19-000087.hdr.sgml : 20190807 20190807160357 ACCESSION NUMBER: 0001005201-19-000087 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20190807 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190807 DATE AS OF CHANGE: 20190807 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Assertio Therapeutics, Inc CENTRAL INDEX KEY: 0001005201 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943229046 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-13111 FILM NUMBER: 191005422 BUSINESS ADDRESS: STREET 1: 100 SOUTH SAUNDERS RD STREET 2: SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 BUSINESS PHONE: (224) 419-7106 MAIL ADDRESS: STREET 1: 100 SOUTH SAUNDERS RD STREET 2: SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 FORMER COMPANY: FORMER CONFORMED NAME: DEPOMED INC DATE OF NAME CHANGE: 19970408 8-K 1 asrtform8-kq22019.htm 8-K Document


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
Form 8-K
 
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
 
Date of Report (Date of earliest event reported):  August 7, 2019
 
ASSERTIO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-13111
 
94-3229046
(State or Other Jurisdiction of
Incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
 
100 S. Saunders Road, Suite 300, Lake Forest, IL 60045
(Address of Principal Executive Offices; Zip Code)
 
(224) 419-7106
(Registrant’s telephone number, including area code)
 
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)

Securities registered pursuant to Section 12(b) of the Act:
Title of each class:
    
Trading Symbol(s):
 
Name of each exchange on which registered:
Common Stock, $0.0001 par value
 
ASRT
 
The Nasdaq Stock Market LLC
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o                                    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o                                    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o                                    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o                                    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company o
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  o

 





Item 2.02
 
Results of Operations and Financial Condition.

On August 7, 2019, Assertio Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and six months ended June 30, 2019.  The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
 
The information in Item 2.02 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. The information contained herein shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
 
Item 9.01
 
Financial Statements and Exhibits.
 
 
 
 
 
(d)
 
Exhibits
 
 
 
 
 
 
 
99.1
 





SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
ASSERTIO THERAPEUTICS, INC.
 
 
 
Date: August 7, 2019
By:
/s/ Daniel A. Peisert
 
 
Daniel A. Peisert
 
 
Senior Vice President and Chief Financial Officer



EX-99.1 2 asrt2q2019earningsreleasee.htm EXHIBIT 99.1 Exhibit
Exhibit 99.1
 image0a03.jpg
Assertio Therapeutics Announces Strong Second-Quarter 2019 Results

-- Reports Total Company GAAP Net Sales of $57.2 million, Total Company Non-GAAP Net Sales of $59.3 million, including Commercialization Agreement Revenues of $31.0 million --

-- Drives Continued Improvement in Operating Efficiencies as the Company
Executes on its Ongoing Transformation --

-- Confirms 2019 Earnings Guidance Range and Adjusts Neurology Franchise Net Sales Guidance --

-- Continues to Reduce Senior Secured Debt --

Lake Forest, Ill., August 7, 2019 - Assertio Therapeutics, Inc. (NASDAQ: ASRT) today reported financial results for the quarter ended June 30, 2019 and provided an update on its business performance and strategic initiatives.

Second-Quarter Financial Highlights:
(unaudited)
 
 Second Quarter 2019
(in millions, except earnings per share)
GAAP
Non-GAAP(1) 
Total Revenues
$57.2
$59.3
Net Income/(Loss)
$(13.6)
$18.5
Earnings/(Loss) Per Share
$(0.21)
$0.25
Adjusted EBITDA
-
$36.7
        
(1) All non-GAAP measures included in this earnings release are reconciled to the corresponding GAAP measures in the schedules attached.

         
“We continue to make steady progress toward building a leading diversified biopharmaceutical business as we deliver strong results and de-lever our balance sheet,” said Arthur Higgins, President and CEO of Assertio. “We remain focused on improving our financial position as we pursue business development opportunities across a range of new therapeutic areas.”

  





1


Second Quarter Business Highlights:
Neurology Franchise Net Sales: Gralise net sales in the second quarter were $17.8 million, primarily due to favorable year-over-year gross to net reflecting payor mix. In August, the Company executed an agreement that provides expanded access for Gralise through new coverage with one of the top three Medicare Part-D insurers, representing more than 6 million lives. Obtaining expanded Medicare Part-D access is important for Gralise as a majority of patients with postherpetic neuralgia are more than 65 years old. In the second quarter, Zipsor net sales were $1.5 million, adversely impacted by short-dated product sales returns; however, underlying prescription demand for Zipsor continues to grow double digits year-over-year. CAMBIA net sales in the second quarter were $6.8 million, primarily due to unfavorable year-over-year gross to net reflecting payor mix. Underlying prescription demand for CAMBIA increased mid single digits year-over-year.

Debt Reduction and Cash Position: As of August 7, 2019, the Company has made scheduled principal repayments of $100.0 million in 2019, reducing the Company’s senior secured debt to $182.5 million. The Company will make an additional $20 million principal payment before year end, reducing senior secured debt to $162.5 million. As of June 30, 2019, the Company had cash and cash equivalents and short-term investments of $75.5 million.

One-Year Anniversary of Headquarters Relocation, Reincorporation and Name Change to Assertio Therapeutics, Inc.: Approximately one year ago, the Company completed its reincorporation from California to Delaware and changed its name from “Depomed, Inc.” to “Assertio Therapeutics, Inc.” In connection with the reincorporation and name change, the Company’s common stock began trading under a new ticker symbol “ASRT.” The Company also completed the relocation of its corporate headquarters from Newark, CA, to Lake Forest, IL.





2






Revenue Summary:
(in thousands, unaudited)

 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018
Product sales, net
 

 
 

 
 

 
 

Gralise
$
17,800

 
$
13,815

 
$
31,078

 
$
28,642

CAMBIA
6,758

 
8,089

 
15,566

 
14,505

Zipsor
1,524

 
3,988

 
5,755

 
8,734

Total neurology product sales, net
26,082

 
25,892

 
52,399

 
51,881

 
 
 
 
 
 
 
 
NUCYNTA products
(163
)
 
626

 
(101
)
 
18,771

Lazanda
18

 
320

 
89

 
540

Total product sales, net
25,937

 
26,838

 
52,387

 
71,192

 
 
 
 
 
 
 
 
Commercialization agreement:
 
 
 
 
 
 
 
Commercialization rights and facilitation services
31,003

 
31,179

 
61,859

 
59,274

Revenue from transfer of inventory

 

 

 
55,705

Royalties and Milestone Revenue
263

 
5,257

 
886

 
5,507

 
 
 
 
 
 
 
 
Total revenues
$
57,203

 
$
63,274

 
$
115,132

 
$
191,678


2019 Financial Guidance:
The Company is confirming its previous 2019 earnings guidance range and adjusting its Neurology Franchise net sales guidance to low-single digits, reflecting the adverse impact of Zipsor short-dated product sales returns.
 
Prior 2019 Guidance
Current 2019 Guidance
Neurology Franchise Net Sales
Low to Mid-Single Digit Growth
Low-Single Digit Growth
GAAP Net Loss(1)
($68) to ($58) million
($68) to ($58) million
Non-GAAP Adjusted EBITDA(1)(2)
$118 to $128 million
$118 to $128 million
(1) Guidance includes $2.8 million of non-cash Collegium warrant related income and excludes any future warrant mark-to-market adjustments, which cannot be estimated.
(2) Guidance excludes any Collegium warrant mark-to-market adjustments.







3






Conference Call and Webcast:
Assertio will host a conference call today, Wednesday, August 7, 2019 beginning at 4:30 p.m. ET to discuss its results. This event can be accessed in three ways:

From the Assertio website: http://investor.assertiotx.com. Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

By telephone: Participants can access the call by dialing (877) 550-3745 (United States) or (281) 973-6277 (International) referencing Conference ID 7769879.

By replay: A replay of the webcast will be located under the Investor Relations section of Assertio’s website approximately two hours after the conclusion of the live call.

About Assertio Therapeutics, Inc.
Assertio Therapeutics is committed to providing responsible solutions to advance patient care in the Company’s core areas of neurology, orphan and specialty medicines. Assertio currently markets three FDA-approved products and continues to identify, license and develop new products that offer enhanced options for patients that may be under served by existing therapies. To learn more about Assertio, visit www.assertiotx.com.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This news release contains forward-looking statements. These statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated, including risks related to regulatory approval and clinical development of long-acting cosyntropin, expectations regarding royalties to be received based on sales of NUCYNTA and NUCYNTA ER, expectations regarding potential business opportunities and other risks outlined in the Company’s public filings with the Securities and Exchange Commission, including the Company’s most recent annual report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. All information provided in this news release speaks as of the date hereof. Except as otherwise required by law, the Company undertakes no obligation to update or revise its forward-looking statements.

Investor and Media Contact:
John B. Thomas
Senior Vice President, Investor Relations and Corporate Communications
jthomas@assertiotx.com



4


Non-GAAP Financial Measures
To supplement the Company’s financial results presented on a U.S. generally accepted accounting principles (GAAP) basis, the Company has included information about non-GAAP revenue, non-GAAP adjusted earnings, non-GAAP adjusted diluted earnings per share, non-GAAP adjusted EBITDA and other non-GAAP financial measures as useful operating metrics. The Company believes that the presentation of these non-GAAP financial measures, when viewed with results under GAAP and the accompanying reconciliation, provides supplementary information to analysts, investors, lenders, and the Company’s management in assessing the Company’s performance and results from period to period. The Company uses these non-GAAP measures internally to understand, manage and evaluate the Company’s performance, and in part, in the determination of bonuses for executive officers and employees. These non-GAAP financial measures 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 financial measures used by us may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

Specified Items
Non-GAAP measures presented within this release exclude specified items. The Company considers specified items to be significant income/expense items not indicative of current operations, including the related tax effect. Specified items include non-cash adjustment to Collegium agreement revenue and cost of sales, release of NUCYNTA and Lazanda sales reserves for products the Company is no longer selling, interest income, interest expense, amortization, acquired in-process research and development and non-cash adjustments related to product acquisitions, stock-based compensation expense, non-cash interest expense related to debt, depreciation, taxes, transaction costs, CEO transition, restructuring costs, adjustments to net sales related to reserves recorded prior to the Company’s exit of opioid commercialization activities, legal costs and expenses incurred in connection with opioid-related litigation, investigations and regulations pertaining to the company’s historical commercialization of opioid products, certain types of legal settlements, disputes, fees and costs, and to adjust for the tax effect related to each of the non-GAAP adjustments.



5


CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Product sales, net
$
25,937

 
$
26,838

 
$
52,387

 
$
71,192

Commercialization agreement, net
31,003

 
31,179

 
61,859

 
114,979

Royalties and milestones
263

 
5,257

 
886

 
5,507

Total revenues
57,203

 
63,274

 
115,132

 
191,678

Costs and expenses:
 
 
 
 
 
 
 
Cost of sales (excluding amortization of intangible assets)
2,124

 
2,753

 
4,699

 
14,797

Research and development expenses
1,263

 
2,180

 
3,056

 
3,708

Selling, general and administrative expenses
24,755

 
31,308

 
49,800

 
60,341

Amortization of intangible assets
25,443

 
25,444

 
50,887

 
50,888

Restructuring charges

 
5,814

 

 
14,831

Total costs and expenses
53,585

 
67,499

 
108,442

 
144,565

Income (loss) from operations
3,618

 
(4,225
)
 
6,690

 
47,113

Other (expense) income:
 
 
 
 
 
 
 
Interest expense
(14,842
)
 
(17,010
)
 
(31,396
)
 
(35,078
)
Other (expense) income, net
(1,240
)
 
67

 
(1,849
)
 
296

Total other expense
(16,082
)
 
(16,943
)
 
(33,245
)
 
(34,782
)
Net (loss) income before income taxes
(12,464
)
 
(21,168
)
 
(26,555
)
 
12,331

Income taxes (expense) benefit
(1,141
)
 
120

 
(1,351
)
 
445

Net (loss) income
$
(13,605
)
 
$
(21,048
)
 
$
(27,906
)
 
$
12,776

Basic net (loss) income per share
(0.21
)
 
(0.33
)
 
(0.43
)
 
0.20

Diluted net (loss) income per share
(0.21
)
 
(0.33
)
 
(0.43
)
 
0.20

Shares used in computing basic net (loss) income per share
64,480

 
63,719

 
64,405

 
63,611

Shares used in computing diluted net (loss) income per share
64,480

 
63,719

 
64,405

 
64,107



6


CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
 
 
June 30, 2019
 
December 31, 2018
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
68,348

 
$
110,949

Short-term investments
7,114

 

Accounts receivable, net
34,311

 
37,211

Inventories, net
3,005

 
3,396

Prepaid and other current assets
26,231

 
56,551

Total current assets
139,009

 
208,107

Property and equipment, net
13,050

 
13,064

Intangible assets, net
641,212

 
692,099

Investments
8,589

 
11,784

Other long-term assets
11,014

 
7,812

Total assets
$
812,874

 
$
932,866

LIABILITIES AND SHAREHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
2,188

 
$
6,138

Accrued rebates, returns and discounts
63,808

 
75,759

Accrued liabilities
19,648

 
31,361

Current portion of Senior Notes
80,000

 
120,000

Interest payable
9,194

 
11,645

Other current liabilities
2,100

 
1,133

Total current liabilities
176,938

 
246,036

Contingent consideration liability
953

 
1,038

Senior Notes
117,527

 
158,309

Convertible Notes
297,550

 
287,798

Other long-term liabilities
22,467

 
19,350

Total liabilities
615,435

 
712,531

Commitments and contingencies
 
 
 
Shareholders’ equity:
 
 
 
Common stock
6

 
6

Additional paid-in capital
407,944

 
402,934

Accumulated deficit
(210,506
)
 
(182,600
)
Accumulated other comprehensive loss
(5
)
 
(5
)
Total shareholders’ equity
197,439

 
220,335

Total liabilities and shareholders' equity
$
812,874

 
$
932,866



7

Exhibit 99.1

RECONCILIATION OF GAAP NET INCOME (LOSS) TO NON-GAAP ADJUSTED EBITDA
(in thousands)
(unaudited)
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018
GAAP net (loss)/income
$
(13,605
)
 
$
(21,048
)
 
$
(27,906
)
 
$
12,776

Commercialization agreement revenues (1)
1,933

 
3,198

 
3,863

 
(49,288
)
Commercialization agreement cost of sales (2)

 

 

 
6,200

NUCYNTA sales reserve (3)

 

 

 
(10,711
)
NUCYNTA and Lazanda revenue reserves (4)
145

 
(946
)
 
12

 
(1,166
)
Expenses for opioid-related litigation, investigations and regulations (5)
2,350

 
2,220

 
4,850

 
3,047

Intangible amortization related to product acquisitions
25,443

 
25,444

 
50,887

 
50,888

Contingent consideration related to product acquisitions
(142
)
 
(260
)
 
(142
)
 
(462
)
Stock-based compensation
2,634

 
2,970

 
5,336

 
4,946

Interest and other income
(172
)
 
(70
)
 
(673
)
 
(164
)
Interest expense
14,842

 
17,010

 
31,396

 
35,078

Depreciation
279

 
1,454

 
616

 
2,929

Income taxes (expense) benefit
1,141

 
(120
)
 
1,351

 
(445
)
Restructuring and related costs  (6)

 
6,974

 

 
15,299

Other costs

 
(31
)
 

 
178

Fair value for warrants
1,848

 

 
3,477

 

Non-GAAP adjusted EBITDA
$
36,696

 
$
36,795

 
$
73,067

 
$
69,105


(1) For the period from January 8, 2018 through November 8, 2018, the adjustment relates to the non-cash value assigned to inventory transferred to Collegium. As of the date of the Commercialization Amendment, on November 8, 2018, the Company ceased recognition of fixed revenues and began the recognition of variable revenues when they become due beginning in January 2019. The adjustment for the three and six months ended June 30, 2019 relates to non-cash expense for third-party royalties, which are expected to have no net impact for the full year period, as well as the amortization of the contract asset.

(2) Represents the cash received for inventory transferred to Collegium at the commencement of the Commercialization Agreement.
 
(3) Represents a $12.5 million benefit related to the release of sales reserves for which the Company is no longer financially responsible, net of $1.8 million in royalties payable to a third party during the three months ended March 31, 2018.
 
(4) Removal of the impact of revenue adjustment estimates related to products that we are no longer commercializing.
 
(5) Legal costs/expenses related to opioid-related litigation, investigations and regulations pertaining to the Company’s historical commercialization of opioid products.
 
(6) Restructuring and other costs represents non-recurring costs associated with the Company’s restructuring, reincorporation, headquarters relocation and CEO transition.

8


RECONCILIATION OF GAAP NET INCOME/(LOSS) TO NON-GAAP ADJUSTED EARNINGS
(in thousands, except per share amounts)
(unaudited) 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018
GAAP net (loss)/income
$
(13,605
)
 
$
(21,048
)
 
$
(27,906
)
 
$
12,776

Commercialization agreement revenues (1)
1,933

 
3,198

 
3,863

 
(49,288
)
Commercialization agreement cost of sales (2)

 

 

 
6,200

Nucynta sales reserve (3)

 

 

 
(10,711
)
Non-cash interest expense on debt
6,056

 
5,390

 
12,220

 
10,808

Nucynta and Lazanda revenue reserves (4)
145

 
(946
)
 
12

 
(1,166
)
Expenses for opioid-related litigation, investigations and regulations (5)
2,350

 
2,220

 
4,850

 
3,047

Intangible amortization related to product acquisitions
25,443

 
25,444

 
50,887

 
50,888

Contingent consideration related to product acquisitions
(142
)
 
(260
)
 
(142
)
 
(462
)
Stock-based compensation
2,634

 
2,970

 
5,336

 
4,946

Restructuring and related costs (6)

 
6,974

 

 
15,304

Other costs

 
(31
)
 
(332
)
 
178

Fair value for warrants
1,848

 

 
3,477

 

Income tax effect of non-GAAP adjustments (7)
(8,124
)
 
(9,067
)
 
(16,163
)
 
(5,623
)
Non-GAAP adjusted earnings
$
18,538

 
$
14,844

 
$
36,102

 
$
36,897

Add interest expense of convertible debt, net of tax (8)
1,703

 
1,703

 
3,406

 
3,406

Numerator
$
20,241

 
$
16,547

 
$
39,508

 
$
40,303

Shares used in calculation (8)
82,411

 
82,201

 
82,336

 
82,039

Non-GAAP adjusted diluted earnings per share
$
0.25

 
$
0.20

 
$
0.48

 
$
0.49

 
(1) For the period from January 8, 2018 through November 8, 2018, the adjustment relates to the non-cash value assigned to inventory transferred to Collegium. As of the date of the Commercialization Amendment, on November 8, 2018, the Company ceased recognition of fixed revenues and will begin recognition of variable revenues when they become due beginning in January 2019. The adjustment for the three and six months ended June 30, 2019 relates to non-cash expense for third-party royalties, which are expected to have no net impact for the full year period, as well as the amortization of the contract asset.

(2) Represents the cash received for inventory transferred to Collegium at the commencement of the Commercialization Agreement.
 
(3) Represents a $12.5 million benefit related to the release of sales reserves for which the Company is no longer financially responsible, net of $1.8 million in royalties payable to a third party during the three months ended March 31, 2018.
 
(4) Removal of the impact of revenue adjustment estimates related to products that we are no longer commercializing.
 
(5) Legal costs/expenses related to opioid-related litigation, investigations and regulations pertaining to the Company’s historical commercialization of opioid products.
 
(6) Restructuring and other costs represents non-recurring costs associated with the Company’s restructuring, reincorporation, headquarters relocation and CEO transition.
 
(7) Calculated by taking the pre-tax non-GAAP adjustments and applying the statutory tax rate.
 
(8) The Company uses the if-converted method to compute diluted earnings per share with respect to its convertible debt.

9


RECONCILIATION OF GAAP NET INCOME (LOSS) PER SHARE TO
NON-GAAP ADJUSTED EARNINGS PER SHARE
(unaudited)
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018
 
 
 
 
 
 
 
 
GAAP net (loss)/income per share
$
(0.21
)
 
$
(0.33
)
 
$
(0.43
)
 
$
0.20

Conversion from basic shares to diluted shares
0.05

 
0.07

 
0.09

 
(0.05
)
Commercialization agreement revenues
0.02

 
0.04

 
0.05

 
(0.60
)
Commercialization agreement cost of sales

 

 

 
0.08

NUCYNTA sales reserve

 

 

 
(0.13
)
Non-cash interest expense on debt
0.07

 
0.06

 
0.15

 
0.14

NUCYNTA and Lazanda revenue reserves

 
(0.01
)
 

 
(0.01
)
Expenses for opioid-related litigation, investigations and regulations
0.03

 
0.03

 
0.06

 
0.04

Intangible amortization related to product acquisitions
0.31

 
0.31

 
0.62

 
0.62

Contingent consideration related to product acquisitions

 

 

 
(0.01
)
Stock based compensation
0.03

 
0.04

 
0.06

 
0.06

Restructuring and related costs

 
0.08

 

 
0.18

Change in fair value of warrants
0.02

 

 
0.04

 

Income tax effect of non-GAAP adjustments
(0.10
)
 
(0.11
)
 
(0.20
)
 
(0.07
)
Add interest expense of convertible debt, net of tax
0.03

 
0.02

 
0.04

 
0.04

Non-GAAP adjusted diluted earnings per share
$
0.25

 
$
0.20

 
$
0.48

 
$
0.49



10



RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
For the three months ended June 30, 2019
(in thousands)
(unaudited)

 
 
Commercialization agreement revenues
 
Product Sales
 
Royalties and milestones
 
Cost of sales
 
Research and development expense
 
Selling, general and administrative expense
 
Amortization of intangible assets
 
Interest expense
 
Other (Expense) Income, Net
 
Income taxes (expense) benefit
GAAP as reported
 
$
31,003

 
$
25,937

 
$
263

 
$
2,124

 
$
1,263

 
$
24,755

 
$
25,443

 
$
(14,842
)
 
$
(1,240
)
 
$
(1,141
)
Commercialization agreement revenues and cost of sales
 
1,933

 

 

 

 

 

 

 

 

 

NUCYNTA sales reserve
 

 

 

 

 

 

 

 

 

 

Non-cash interest expense on debt
 

 

 

 

 

 

 

 
6,056

 

 

NUCYNTA and Lazanda revenue reserves
 

 
145

 

 

 

 

 

 

 

 

Expenses for opioid-related litigation, investigations and regulations
 

 

 

 

 

 
(2,350
)
 

 

 

 

Intangible amortization related to product acquisitions
 

 

 

 

 

 

 
(25,443
)
 

 

 

Contingent consideration related to product acquisitions
 

 

 

 

 

 
142

 

 

 

 

Stock based compensation
 

 

 

 
(50
)
 
(76
)
 
(2,508
)
 

 

 

 

Change in fair value of warrants
 

 

 

 

 

 

 

 

 
1,848

 

Other costs
 

 

 

 

 

 

 

 

 

 

Income tax effect of non-GAAP adjustments
 

 

 

 

 

 

 

 

 

 
(8,124
)
Non-GAAP adjusted
 
$
32,936

 
$
26,082

 
$
263

 
$
2,074

 
$
1,187

 
$
20,039

 
$

 
$
(8,786
)
 
$
608

 
$
(9,265
)














11


RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
For the six months ended June 30, 2019
(in thousands)
(unaudited)

 
 
Commercialization agreement revenues
 
Product Sales
 
Royalties and milestones
 
Cost of sales
 
Research and development expense
 
Selling, general and administrative expense
 
Amortization of intangible assets
 
Interest expense
 
Other (Expense) Income, Net
 
Income taxes (expense) benefit
GAAP as reported
 
$
61,859

 
$
52,387

 
$
886

 
$
4,699

 
$
3,056

 
$
49,800

 
$
50,887

 
$
(31,396
)
 
$
(1,849
)
 
$
(1,351
)
Commercialization agreement revenues and cost of sales
 
3,863

 

 

 

 

 

 

 

 

 

Non-cash interest expense on debt
 

 

 

 

 

 

 

 
12,220

 

 

NUCYNTA and Lazanda revenue reserves
 

 
12

 

 

 

 

 

 

 

 

Expenses for opioid-related litigation, investigations and regulations
 

 

 

 

 

 
(4,850
)
 

 

 

 

Intangible amortization related to product acquisitions
 

 

 

 

 

 

 
(50,887
)
 

 

 

Contingent consideration related to product acquisitions
 

 

 

 

 

 
142

 

 

 

 

Stock based compensation
 

 

 

 
(50
)
 
(349
)
 
(4,937
)
 

 

 

 

Change in fair value of warrants
 

 

 

 

 

 

 

 

 
3,477

 

Other costs
 

 

 

 

 

 

 

 

 
(332
)
 

Income tax effect of non-GAAP adjustments
 

 

 

 

 

 

 

 

 

 
(16,163
)
Non-GAAP adjusted
 
$
65,722

 
$
52,399

 
$
886

 
$
4,649

 
$
2,707

 
$
40,155

 
$

 
$
(19,176
)
 
$
1,296

 
$
(17,514
)














12



RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
For the three months ended June 30, 2018
(in thousands)
(unaudited)

 
 
Commercialization agreement revenues
 
Product Sales
 
Royalties and milestones
 
Cost of sales
 
Research and development expense
 
Selling, general and administrative expense
 
Restructuring Charges
 
Amortization of intangible assets
 
Interest expense
 
Other (Expense) Income, Net
 
Income taxes (expense) benefit
GAAP as reported
 
$
31,179

 
$
26,838

 
$
5,257

 
$
2,753

 
$
2,180

 
$
31,308

 
$
5,814

 
$
25,444

 
$
(17,010
)
 
$
67

 
$
120

Commercialization agreement revenues and cost of sales
 
3,198

 

 

 

 

 

 
 
 

 

 

 

Non-cash interest expense on debt
 

 

 

 

 

 

 

 

 
5,390

 

 

NUCYNTA and Lazanda revenue reserves
 

 
(946
)
 

 

 

 

 

 

 

 

 

Expenses for opioid-related litigation, investigations and regulations
 

 

 

 

 

 
(2,220
)
 

 

 

 

 

Intangible amortization related to product acquisitions
 

 

 

 

 

 

 

 
(25,444
)
 

 

 

Contingent consideration related to product acquisitions
 

 

 

 

 

 
260

 

 

 

 

 

Stock based compensation
 

 

 

 
(16
)
 
(14
)
 
(2,940
)
 

 

 

 

 

Restructuring and other costs
 

 

 

 

 

 
31

 
(6,974
)
 

 

 

 

Income tax effect of non-GAAP adjustments
 

 

 

 

 

 

 

 

 

 

 
(9,067
)
Non-GAAP adjusted
 
$
34,377

 
$
25,892

 
$
5,257

 
$
2,737

 
$
2,166

 
$
26,439

 
$
(1,160
)
 
$

 
$
(11,620
)
 
$
67

 
$
(8,947
)














13





RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
For the six months ended June 30, 2018
(in thousands)
(unaudited)
 
 
Commercialization agreement revenues
 
Product Sales
 
Royalties and milestones
 
Cost of sales
 
Research and development expense
 
Selling, general and administrative expense
 
Restructuring Charges
 
Amortization of intangible assets
 
Interest expense
 
Other (Expense) Income, Net
 
Income taxes (expense) benefit
GAAP as reported
 
114,979

 
71,192

 
5,507

 
14,797

 
3,708

 
60,341

 
14,831

 
50,888

 
(35,078
)
 
296

 
445

Commercialization agreement revenues and cost of sales
 
(49,288
)
 
 
 

 
(6,200
)
 

 

 
 
 

 

 

 

NUCYNTA sales reserve
 

 
(10,711
)
 

 

 

 

 

 

 

 

 

Non-cash interest expense on debt
 

 

 

 

 

 

 

 

 
10,808

 

 

NUCYNTA and Lazanda revenue reserves
 

 
(1,166
)
 

 

 

 

 

 

 

 

 

Expenses for opioid-related litigation, investigations and regulations
 

 

 

 

 

 
(3,047
)
 

 

 

 

 

Intangible amortization related to product acquisitions
 

 

 

 

 

 
 
 

 
(50,888
)
 

 

 

Contingent consideration related to product acquisitions
 

 

 

 

 

 
462

 

 

 

 

 

Stock based compensation
 

 

 

 
(30
)
 
(67
)
 
(4,849
)
 

 

 

 

 

Restructuring and other costs
 

 

 

 

 

 
(178
)
 
(15,304
)
 

 

 

 

Income tax effect of non-GAAP adjustments
 

 

 

 

 

 

 

 

 

 

 
(5,623
)
Non-GAAP adjusted
 
65,691

 
59,315

 
5,507

 
8,567

 
3,641

 
52,729

 
(473
)
 

 
(24,270
)
 
296

 
(5,178
)


14



SECOND-QUARTER RECONCILIATION OF GAAP to NON-GAAP REVENUES
(in thousands)
(unaudited)
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018(1)
Total revenues (GAAP basis)
$
57.2

 
$
63.3

 
$
115.1

 
$
191.7

      Non-cash adjustment to commercialization
      agreement revenues(2)
2.1

 
2.2

 
3.9

 
(48.7
)
Release of NUCYNTA sales reserves(3)

 

 

 
(12.5
)
Total revenues (non-GAAP basis)
$
59.3

 
$
65.5

 
$
119.0

 
$
130.5


(1) Year-to-date 2018 total GAAP revenues include one-time items described in our quarterly report on Form 10-Q for the six months ended June 30, 2018.

(2) The adjustments for the three and six months ended June 30, 2019 relate to non-cash adjustments for third-party royalties, which were a net expense but are expected to have no net impact for the full year period, the amortization of the contract asset, and the impact of revenue adjustment estimates related to products that we are no longer commercializing. For the three months ended June 30, 2018 the adjustment relates to non-cash adjustments for third party royalties and for the six months ended June 30, 2018 the adjustment relates primarily to the non-cash value assigned to inventory transferred to Collegium.

(3) Represents a $12.5 million benefit related to the release of sales reserves for which the Company is no longer financially responsible.





FULL-YEAR 2019 NON-GAAP GUIDANCE RECONCILATION
(in millions)
(unaudited)
 
Earnings (1)
 
Low End
High End
GAAP
 
$
(68
)
 
$
(58
)
Specified Items(2)
 
$
186

 
$
186

Non-GAAP
 
$
118

 
$
128

 
(1) GAAP net income guidance refers to GAAP net income and non-GAAP earnings guidance refers to non-GAAP adjusted EBITDA.
 
(2) For purposes of this forward-looking reconciliation, a description of the categories of specified items included in this reconciliation are detailed in the tables above.

15


SENIOR SECURED NOTE COVENANT DISCLOSURES

The Company was in compliance with its covenants, including the Senior Secured Debt Leverage Ratio and Net Sales covenants, with respect to the Company’s senior secured notes as of June 30, 2019. Set forth below are additional disclosures that the Company is required to make in connection with the senior secured notes.

RECONCILIATION OF GAAP NET INCOME (LOSS) TO NON-GAAP ADJUSTED EBITDA
For the Rolling Twelve Month Period Ended June 30, 2019
(in thousands)
(unaudited)

The below reconciliation is presented to disclose the calculation of Adjusted EBITDA (as defined in our senior secured notes) on a rolling 12 month basis to support covenant compliance in connection with our senior secured notes.
 
Twelve Month Period
 
Ended June 30, 2019
 
(unaudited)
GAAP net (loss)/income
$
(3,774
)
Commercialization agreement revenues (1)
27,987

Nucynta and Lazanda revenue reserves (2)
(384
)
Expenses for opioid-related litigation, investigations and regulations (3)
9,700

Intangible amortization related to product acquisitions
101,773

Contingent consideration related to product acquisitions
(195
)
Stock-based compensation
10,829

Purdue Litigation
(62,000
)
Interest and other income
(1,706
)
Interest expense
65,199

Depreciation
(382
)
Income taxes (expense) benefit
2,863

Restructuring and related costs  (4)
5,965

Other costs
(55
)
Fair value for warrants
3,477

Adjusted EBITDA
$
159,297


(1) The adjustment for the twelve months ended June 30, 2019 relates to non-cash expense for third-party royalties, which are expected to have no net impact for the full year period, as well as the amortization of the contract asset.

(2) Removal of the impact of revenue adjustment estimates related to products that we are no longer commercializing.
 
(3) Legal costs/expenses related to opioid-related litigation, investigations and regulations pertaining to the Company’s historical commercialization of opioid products.
 
(4) Restructuring and other costs represents non-recurring costs associated with the Company’s restructuring, reincorporation, headquarters relocation and CEO transition.

Additional Covenant Disclosures

Long-acting cosyntropin has not yet been launched for commercial sale and therefore no revenue in respect of this product was recognized by the Company as of June 30, 2019.

During the rolling twelve month period ended June 30, 2019, the Company collected $128.2 million in cash receipts, net of cash payments made, in connection with the Company’s Commercialization Agreement with Collegium.

16
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