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8-K - 8-K - Assertio Therapeutics, Incasrtform8-kq42019.htm
Exhibit 99.1
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Assertio Therapeutics Announces Fourth-Quarter and Full-Year 2019 Financial Results

-- Reports Neurology Franchise Annual Net Sales of $108.1 Million, Exceeding Upper End of Prior Guidance --

-- Completed Strategic Asset Sales of NUCYNTA® Franchise and Gralise® Totaling $502.5 Million --

-- Repaid in Full Senior Secured Debt and Reduced Convertible Debt by $188.0 Million --


Lake Forest, Ill., March 9, 2020 - Assertio Therapeutics, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT)
today reported financial results for the fourth quarter and year ended December 31, 2019 and provided an update on its business performance and strategic initiatives.

Financial Highlights:
(unaudited)
 
 Fourth-Quarter 2019
Full-Year 2019
(in millions, except earnings per share)
GAAP
Non-GAAP(1) 
GAAP
Non-GAAP(1) 
Total Revenues
$59.2
$229.5
Net Income/(Loss)
$(192.6)
$(16.2)
$(217.2)
$46.8
Earnings/(Loss) Per Share
$(2.65)
$(0.14)
$(3.07)
$0.47
Adjusted EBITDA
$31.0
$138.4
        
(1) All non-GAAP measures included in this earnings release are reconciled to the corresponding GAAP measures in the schedules attached.

“When I joined Assertio nearly three years ago we had $820 million of debt which significantly restricted our flexibility to do acquisitions and strategic combinations. I am pleased to say that we are now on track to retire our outstanding debt and to have approximately $50 million of cash on our balance sheet,” said Arthur Higgins, President and CEO of Assertio. “We now look to leverage this strengthened balance sheet to create a sustainable and growth-oriented specialty pharmaceutical company. We look forward to presenting our updated strategy for doing so in the near future.”



1


Fourth Quarter and 2019 Business Highlights:
Return to Prescription Growth for CAMBIA® and Zipsor®: For the full-year 2019, total prescriptions grew 4 percent for CAMBIA and 17 percent for Zipsor versus previous year total 2018 prescriptions decline of 3 percent and 24 percent, respectively.

Strong Earnings Performance: The Company has exceeded non-GAAP adjusted EBITDA expectations for the sixth time in the last seven quarters and the upper end of our previously raised full-year 2019 guidance. In addition, excluding a one-time impairment charge for our recently divested NUCYNTA franchise, our full-year GAAP net loss was less than the lower end of our previous lowered guidance.

Significant Debt Reduction: On February 13, 2020, the Company announced that it repaid in full its senior secured debt obligations. The Company also announced it repurchased approximately $188.0 million aggregate with a limited number of holders of Assertio’s Convertible Notes through separate, privately negotiated purchase agreements.
After this repurchase, $42.5 million of the 2.50% Convertible Notes due 2021 and $34.5 million of the 5.00% Convertible Notes due 2024 remain outstanding.
    
Sale of NUCYNTA® Franchise: On February 13, 2020, the Company announced the closing of its definitive agreement with Collegium Pharmaceutical, Inc. pursuant to which Collegium has acquired the NUCYNTA franchise of products from the Company.
Under the terms of the agreement, Collegium paid Assertio $375.0 million in cash at closing, less royalties paid to Assertio in 2020. In addition, Collegium paid Assertio for certain inventories relating to the products.

Sale of Gralise®: On January 10, 2020, the Company completed the sale of Gralise to Alvogen. Under the terms of the agreement, Alvogen is expected to pay Assertio a total value of $127.5 million, plus inventory. At the closing of the transaction, the Company received approximately $78.6 million, of which, $60.5 million of proceeds were used to pay down the Company’s senior secured debt.
The remaining balance is in the form of a royalty on the first $70.0 million in Gralise net sales. Both companies expect the majority of the royalties to be paid in the first calendar year. To ensure a smooth transition, Assertio has agreed to continue to promote Gralise in the first quarter of 2020 and will receive cost reimbursement for promotional activities.


2


Revenue Summary:
(in thousands, unaudited)

 
Three Months Ended December 31,
 
Twelve Months Ended December 31,
 
2019
 
2018
 
2019
 
2018
Product sales, net:
 
 
 
 
 
 
 
Gralise
$
17,116

 
$
14,805

 
$
63,124

 
$
58,077

CAMBIA
8,752

 
10,933

 
32,453

 
35,803

Zipsor
3,470

 
3,212

 
12,498

 
16,387

Total neurology product sales, net
29,338

 
28,950

 
108,075

 
110,267

NUCYNTA products
(226
)
 
162

 
927

 
18,944

Lazanda
(195
)
 
227

 
(196
)
 
755

Total product sales, net
28,917

 
29,339

 
108,806

 
129,966

Commercialization agreement:
 
 
 
 
 
 
 
Commercialization rights and facilitation services, net
29,451

 
12,983

 
118,614

 
100,038

Revenue from transfer of inventory

 

 

 
55,705

Royalties and milestone revenue
858

 
277

 
2,084

 
26,061

Total revenues
$
59,226

 
$
42,599

 
$
229,504

 
$
311,770


2020 Company Strategy:
With the recent completion of sales of the NUCYNTA franchise and Gralise and subsequent reduction in debt, the Company will be providing information about our strategy for 2020 and beyond on a conference call in the near future.

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 two 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. Words such as "anticipates," "estimates," "expects," "projects," "forecasts," "intends," "plans," "will," "believes" and words and terms of similar substance used in connection with any discussion identify forward-looking statements. These forward-looking statements are based on management's current expectations and beliefs about future events and are inherently susceptible to uncertainty and changes in circumstance. Total prescription data is based on Symphony prescriber level data. This includes estimates, which could cause minor fluctuations in historical comparisons. Although this data is not reflective of product revenues, management utilizes this metric to evaluate commercial strategy.These statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated, including risks outlined in Assertio’s public filings with the Securities and Exchange Commission, including Assertio’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, Assertio undertakes no obligation to update or revise its forward-looking statements.

Investor and Media Contact:
Dan Peisert
Senior Vice President and Chief Financial Officer
dpeisert@assertiotx.com

3


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 adjusted EBITDA, non-GAAP adjusted earnings and non-GAAP adjusted earnings per share 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, gains or losses resulting from debt refinancing transactions and disposal or impairment of long-lived assets, and adjustments for the tax effect related to each of the non-GAAP adjustments.



4


CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
 
 
Three Months Ended December 31,
 
Twelve Months Ended December 31,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Product sales, net
$
28,917

 
$
29,339

 
$
108,806

 
$
129,966

Commercialization agreement, net
29,451

 
12,983

 
118,614

 
155,743

Royalties and milestones
858

 
277

 
2,084

 
26,061

Total revenues
59,226

 
42,599

 
229,504

 
311,770

Costs and expenses:
 
 
 
 
 
 
 
Cost of sales (excluding amortization of intangible assets)
2,563

 
704

 
9,505

 
18,476

Research and development expenses
5,575

 
2,207

 
10,106

 
8,042

Selling, general and administrative expenses
22,949

 
25,468

 
108,866

 
119,218

Amortization of intangible assets
25,443

 
25,443

 
101,774

 
101,774

Loss on impairment of intangible asset
189,790

 

 
189,790

 

Restructuring charges
3,891

 
1,859

 
3,891

 
20,601

Total costs and expenses
250,211

 
55,681

 
423,932

 
268,111

(Loss) income from operations
(190,985
)
 
(13,082
)
 
(194,428
)
 
43,659

Other income (expense):
 
 
 
 
 
 
 
Litigation settlement

 

 

 
62,000

Gain on debt extinguishment

 

 
26,385

 

Interest expense
(13,121
)
 
(16,613
)
 
(58,389
)
 
(68,881
)
Other income, net
6,561

 
224

 
3,948

 
1,197

Total other expense
(6,560
)
 
(16,389
)
 
(28,056
)
 
(5,684
)
Net (loss) income before income taxes
(197,545
)
 
(29,471
)
 
(222,484
)
 
37,975

Income tax benefit (expense)
4,919

 
5,333

 
5,283

 
(1,067
)
Net (loss) income
$
(192,626
)
 
$
(24,138
)
 
$
(217,201
)
 
$
36,908

Basic net (loss) income per share
$
(2.65
)
 
$
(0.38
)
 
$
(3.07
)
 
$
0.58

Diluted net (loss) income per share
$
(2.65
)
 
$
(0.38
)
 
$
(3.07
)
 
$
0.57

Shares used in computing basic net (loss) income per share
72,825

 
64,004

 
70,716

 
63,794

Shares used in computing diluted net (loss) income per share
72,825

 
64,004

 
70,716

 
64,208



5


CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
 
 
December 31,
 
2019
 
2018
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
42,107

 
$
110,949

Accounts receivable, net
42,744

 
37,211

Inventories, net
3,412

 
3,396

Prepaid and other current assets
15,688

 
56,551

Total current assets
103,951

 
208,107

Property and equipment, net
3,497

 
13,064

Intangible assets, net
400,535

 
692,099

Investments
13,064

 
11,784

Other long-term assets
6,123

 
7,812

Total assets
$
527,170

 
$
932,866

LIABILITIES AND SHAREHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
16,193

 
$
6,138

Accrued rebates, returns and discounts
58,943

 
75,759

Accrued liabilities
18,948

 
31,361

Current portion of Senior Notes
80,000

 
120,000

Interest payable
8,375

 
11,645

Other current liabilities
2,094

 
1,133

Total current liabilities
184,553

 
246,036

Contingent consideration liability
168

 
1,038

Senior Notes
76,443

 
158,309

Convertible Notes
194,815

 
287,798

Other long-term liabilities
13,233

 
19,350

Total liabilities
469,212

 
712,531

Commitments and contingencies
 
 
 
Shareholders’ equity:
 
 
 
Common stock
8

 
6

Additional paid-in capital
457,751

 
402,934

Accumulated deficit
(399,801
)
 
(182,600
)
Accumulated other comprehensive loss

 
(5
)
Total shareholders’ equity
57,958

 
220,335

Total liabilities and shareholders' equity
$
527,170

 
$
932,866



6


RECONCILIATION OF GAAP NET (LOSS) INCOME TO NON-GAAP ADJUSTED EBITDA AND EARNINGS(1) 
(in thousands, except per share amounts)
(unaudited)

 
 
Three Months Ended December 31,
 
Twelve Months Ended December 31,
 
 
 
 
2019
 
2018
 
2019
 
2018
 
Financial Statement Classification
Net (loss) income (GAAP)
 
$
(192,626
)
 
$
(24,138
)
 
$
(217,201
)
 
$
36,908

 
 
Interest expense
 
13,121

 
16,613

 
58,389

 
68,881

 
Interest expense
Income tax (benefit) expense
 
(4,919
)
 
(5,333
)
 
(5,283
)
 
1,067

 
Income tax benefit (expense)
Depreciation expense
 
278

 
254

 
1,172

 
1,931

 
Selling, general and administrative expenses
Amortization of intangible assets
 
25,443

 
25,443

 
101,774

 
101,774

 
Amortization of intangible assets
EBITDA (Non-GAAP)
 
$
(158,703
)
 
$
12,839

 
$
(61,149
)
 
$
210,561

 
 
Adjustments:
 
 
 
 
 
 
 
 
 
 
NUCYNTA and Lazanda revenue reserves (2)
 
421

 
(1,024
)
 
(731
)
 
(12,273
)
 
Product sales, net
Commercialization agreement revenues (3)
 
(4,071
)
 
21,262

 
3,596

 
(25,164
)
 
Commercialization agreement, net
Commercialization agreement cost of sales (4)
 

 

 

 
6,200

 
Cost of sales (excluding amortization of intangible assets)
Expenses for opioid-related litigation, investigations and regulations (5)
 
2,112

 
3,537

 
9,136

 
7,897

 
Selling, general and administrative expenses
Gralise divestiture-related costs (6)
 
2,227

 

 
2,227

 

 
Selling, general and administrative expenses
Loss on disposal of equipment (7)
 

 

 
10,076

 

 
Selling, general and administrative expenses
Change in fair value of contingent consideration
 
(841
)
 
143

 
(983
)
 
(515
)
 
Selling, general and administrative expenses
Stock-based compensation
 
2,256

 
2,549

 
10,596

 
10,439

 
Multiple (8)
Other (9)
 
(327
)
 
(224
)
 
(1,242
)
 
(1,074
)
 
Multiple (9)
Gain on debt extinguishment, net (10)
 

 

 
(25,968
)
 

 
Multiple (10)
Loss on intangible impairment (11)
 
189,790

 

 
189,790

 

 
Loss on impairment of intangible asset
Restructuring and related costs (12)
 
3,891

 
1,881

 
3,891

 
21,264

 
Restructuring charges
Purdue litigation settlement
 

 

 

 
(62,000
)
 
Litigation settlement
Change in fair value of warrants
 
(5,745
)
 

 
(845
)
 

 
Other income, net
Adjusted EBITDA (Non-GAAP)
 
$
31,010

 
$
40,963

 
$
138,394

 
$
155,335

 
 
 
 
 
 
 
 
 
 
 
 
 
Adjusted EBITDA (Non-GAAP)
 
31,010

 
40,963

 
138,394

 
155,335

 
 
Depreciation expense
 
(278
)
 
(254
)
 
(1,172
)
 
(1,931
)
 
 
Cash portion of Senior Notes interest expense (13)
 
(5,015
)
 
(8,859
)
 
(25,559
)
 
(38,242
)
 
 
Income taxes expense (benefit), as adjusted (14)
 
(41,960
)
 
(7,219
)
 
(64,865
)
 
(15,932
)
 
 
Adjusted earnings (Non-GAAP) (15)
 
$
(16,243
)
 
$
24,631

 
$
46,798

 
$
99,230

 
 
 
 
 
 
 
 
 
 
 
 
 
Shares used in calculation (16)
 
119,197

 
81,935

 
99,506

 
82,139

 
 
Adjusted earnings per share (Non-GAAP)
 
$
(0.14
)
 
$
0.30

 
$
0.47

 
$
1.21

 
 

Refer to the next page for table footnotes

7




(1) Effective as of the year ended December 31, 2019, the Company combined the reconciliation of GAAP net (loss) income to non-GAAP adjusted EBITDA and to non-GAAP adjusted earnings into a singular, consolidated schedule for all periods presented. References to the respective financial statement classification in the Company’s consolidated statement of comprehensive income are also included within this reconciliation table. Previously, these reconciliations were presented separately as supplemental tables.
(2) Removal of the impact of revenue adjustment estimates related to products that we are no longer commercializing. The twelve months ended December 31, 2018 included 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 recognized in the first quarter of 2018.
(3) 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 twelve months ended December 31, 2019 relates to non-cash expense for third-party royalties, which have no net impact for the full year period, as well as the amortization of the contract asset.
(4) Represents the cash received for inventory transferred to Collegium at the commencement of the Commercialization Agreement. 
(5) Legal costs/expenses related to opioid-related litigation, investigations and regulations pertaining to the Company’s historical commercialization of opioid products. 
(6) On December 11, 2019 the Company entered into an Asset Purchase Agreement for the sale of Gralise to Alvogen. In connection, the Company recognized a loss on certain prepaid assets of $1.7 million and incurred transaction-related costs of $0.4 million during the twelve months ended December 31, 2019. The transaction subsequently closed on January 10, 2020.
(7) Recognition of $10.1 million loss on the September 2019 disposal of equipment residing at a manufacturing supplier that will no longer be used in future production.
(8) Stock based compensation for the three months ended December 31, 2019 and 2018, included $0.2 million and $0.1 million in Research and development expense, respectively, and $2.0 million and $2.4 million in Selling, general and administrative expenses, respectively. Stock based compensation for the twelve months ended December 31, 2019 and 2018 included $0.1 million related to Cost of sales (excluding amortization of intangible assets), $0.7 million and $0.4 million related to Research and development expense, respectively, and $9.8 million and $9.9 million related Selling, general and administrative expenses, respectively.
(9) Represents adjustments for certain income and expenses related to non-recurring items not reflective of ongoing operations. For the three and twelve months ended December 31, 2019, other income of $0.3 million and $1.2 million were recognized in Other income, net, respectively. For the three and twelve months ended December 31, 2018, other income of $0.2 million and $1.2 million were recognized in Other income, net, respectively. For the year ended December 31, 2018, $0.1 million of other costs were recognized in Selling, general and administrative expenses.
(10) In connection with the August 2019 debt refinancing of the convertible notes the Company recognized a net gain of $26.0 million, comprised of a $26.4 million gain on debt extinguishment offset by approximately $0.4 million of nonrecurring related expenses, reflected in Gain on debt extinguishment and Selling, general, and administrative expenses, respectively.
(11) At December 31, 2019 the Company recognized impairment charge of $189.8 million on its NUCYNTA intangible.
(12) Restructuring and other costs represents non-recurring costs associated with the Company’s 2019 cost-saving initiative and 2017 restructuring, including reincorporation, headquarters relocation and CEO transition.
(13) Represents the contractual annual basis interest expense for the Senior Notes. The amount excludes convertible debts interest expense because the Company computes non-GAAP adjusted earnings using the if-converted method assuming the convertible debt is converted to equity at the beginning of each period presented.
(14) Represents the Company’s income tax (benefit) expense adjusted for the tax effect of pre-tax non-GAAP adjustments excluded from adjusted earnings. The tax effect of pre-tax non-GAAP adjustments excluded from non-GAAP adjusted earnings is computed at the statutory rate of 21%.
(15) Effective as of the year ended December 31, 2019, the Company updated their definition of non-GAAP adjusted earnings to exclude income and expenses related to non-recurring items as these items are not reflective of ongoing operations. Comparative periods have been adjusted to conform with current period presentation, which resulted in a decrease of non-GAAP adjusted earnings of $0.2 million and $0.8 million for the three and twelve months ended December 31, 2018, respectively.
(16) The Company uses the if-converted method to compute adjusted diluted earnings per share with respect to its convertible debt.



8


RECONCILIATION OF GAAP NET (LOSS) INCOME PER SHARE TO (1) 
NON-GAAP ADJUSTED EARNINGS PER SHARE
(unaudited)
 
 
Three Months Ended December 31,
 
Twelve Months Ended December 31,
 
2019
 
2018
 
2019
 
2018
Diluted net (loss) income per share (GAAP)
$
(2.65
)
 
$
(0.38
)
 
$
(3.07
)
 
$
0.57

Conversion to adjusted diluted shares (2)
1.03

 
0.09

 
0.89

 
(0.13
)
Adjustments:
 
 
 
 
 
 
 
NUCYNTA and Lazanda revenue reserves

 
(0.01
)
 
(0.01
)
 
(0.15
)
Commercialization agreement revenues
(0.03
)
 
0.26

 
0.04

 
(0.30
)
Commercialization agreement cost of sales

 

 

 
0.08

Expenses for opioid-related litigation, investigations and regulations
0.02

 
0.04

 
0.09

 
0.10

Gralise divestiture-related costs
0.02

 
 
 
0.02

 
 
Intangible amortization related to product acquisitions
0.21

 
0.31

 
1.02

 
1.24

Loss on disposal of equipment

 

 
0.10

 

Change in fair value of contingent consideration
(0.01
)
 

 
(0.01
)
 
(0.01
)
Stock based compensation
0.02

 
0.03

 
0.11

 
0.13

Other

 
 
 
(0.01
)
 
 
Gain on debt extinguishment,net

 

 
(0.26
)
 

Loss in intangible impairment
1.59

 

 
1.91

 

Restructuring and related costs
0.03

 
0.02

 
0.04

 
0.26

Purdue litigation settlement

 

 

 
(0.75
)
Change in fair value of warrants
(0.05
)
 

 
(0.01
)
 

Non-cash interest expense on debt (3)
0.07

 
0.09

 
0.33

 
0.37

Income tax effect of non-GAAP adjustments (4)
(0.39
)
 
(0.15
)
 
(0.71
)
 
(0.19
)
Adjusted earnings per share (Non-GAAP)
$
(0.14
)
 
$
0.30

 
$
0.47

 
$
1.21


(1) Represents per share calculations of adjustments reflective in the Company’s reconciliation of GAAP net (loss) income to non-GAAP adjusted earnings and therefore should be read in conjunction with that reconciliation and respective footnotes.
(2) The Company uses the if-converted method to compute adjusted diluted earnings per share with respect to its convertible debt.
(3) Represents per share adjustment for interest expense, net of cash portion of Senior Notes interest expense.
(4) Represents the Company’s income tax (benefit) expense adjusted for the tax effect of pre-tax non-GAAP adjustments excluded from adjusted earnings. The tax effect of pre-tax non-GAAP adjustments excluded from non-GAAP adjusted earnings is computed at the statutory rate of 21%.


9