EX-99.1 2 a19-16724_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

Osmotica Pharmaceuticals plc Reports Second Quarter 2019 Results

 

Second quarter 2019 total revenue of $57.5 million

 

On track to submit NDA for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for acquired blepharoptosis, or droopy eyelid, by end of Q3 2019

 

Bridgewater, NJ, August 8, 2019 — Osmotica Pharmaceuticals plc (“Osmotica” or the “Company”) (Nasdaq: OSMT), a fully integrated biopharmaceutical company, today announced business highlights and financial results for the quarter ended June 30, 2019.

 

“During the second quarter, we continued to make meaningful progress in our ongoing transition towards becoming a specialty branded pharmaceutical company.  We once again saw prescription growth from key promoted brands — Divigel®, methylphenidate hydrochloride ER 72 mg (M-72), and Osmolex ER™ (amantadine extended-release tablets) — as well as the previously announced successful completion of our clinical program for RVL-1201, our potential first-in-class ophthalmic solution in development for the treatment of droopy eyelid.  We remain on track to submit our NDA for RVL-1201 by the end of the third quarter of 2019.  We are also in dialogue with the FDA to discuss the potential resubmission of our NDA for arbaclofen ER, and remain optimistic based on the strength of our clinical efficacy and safety data in M.S. spasticity,” stated Brian Markison, Chief Executive Officer.

 

“Combined with the significant and compelling opportunity we have with RVL-1201, our late-stage pipeline represents a tremendous opportunity,” added Markison.

 

Second Quarter 2019 Financial Results

 

·                       Total revenues were $57.5 million, compared to $71.9 million in the second quarter of 2018;

 

·                       Net loss was $124.7 million, including an impairment charge of $125.8 million, compared to net income of $5.9 million in the second quarter of 2018;

 

·                       Adjusted EBITDA(1) was $14.5 million, compared to Adjusted EBITDA of $34.6 million in the second quarter of 2018; and

 

·                       Cash and cash equivalents were $63.7 million and debt (net of deferred financing costs) was $267.4 million as of June 30, 2019.

 


(1) Adjusted EBITDA is a non-GAAP measure. Adjusted EBITDA is more fully described and reconciled from net loss determined under U.S. generally accepted accounting principles (“GAAP”) in “Presentation of Non-GAAP Measures” and the attached table “Osmotica Pharmaceuticals plc GAAP to Non-GAAP Reconciliations.”

 


 

Second Quarter 2019 Financial Results

 

Total revenues decreased by $14.3 million to $57.5 million for the three months ended June 30, 2019, as compared to $ 71.9 million for the three months ended June 30, 2018, primarily due to a decrease in net product sales.

 

Net product sales decreased by $15.8 million to $56.2 million for the three months ended June 30, 2019, as compared to $72.0 million for the three months ended June 30, 2018, largely due to declines in sales of methylphenidate ER and venlafaxine ER tablets (VERT). Net sales of methylphenidate ER (including M-72 which was launched in the second quarter of 2018) decreased by 56% during the quarter due to additional competitors entering the market resulting in significantly lower net selling prices.  VERT net sales decreased 7%, reflecting lower sales volumes following the launch of a competing product in the largest dosage strength during the quarter, partially offset by higher realized net selling prices due to lower than estimated product returns.

 

Selling, general and administrative expenses increased $8.8 million during the three months ended June 30, 2019 to $25.5 million as compared to $16.7 million in the three months ended June 30, 2018. The increase reflects additions to salesforce headcount and marketing costs associated with the launch of Osmolex ER, together with share compensation expense and higher costs associated with being a public company.

 

Research and development expenses decreased by $3.5 million in the three months ended June 30, 2019 to $5.4 million as compared to $8.9 million in the three months ended June 30, 2018. The decrease reflects the completion of Phase III clinical trials of both arbaclofen ER and RVL-1201 during the first and second quarters of 2019, respectively, partially offset by share compensation expense.

 

The Company incurred an impairment of intangible assets charge of $125.8 million during the three months ended June 30, 2019, primarily related to the write down to fair value of VERT due to price and volume decreases resulting from competing generic products, a slower sales uptake of Osmolex ER and the decision to discontinue selling a formulation of Corvite

 

Net loss for the second quarter of 2019 was $124.7 million, compared to net income of $5.9 million in the second quarter of 2018.

 

Adjusted EBITDA for the second quarter of 2019 was $14.5 million, compared to Adjusted EBITDA of $34.6 million in the second quarter of 2018.

 

For a reconciliation of Adjusted EBITDA to net loss (income), the most comparable GAAP financial measure, please see the “Osmotica Pharmaceuticals plc GAAP to Non-GAAP Reconciliations” table at the end of this press release.

 


 

Liquidity

 

As of June 30, 2019, Osmotica had cash and cash equivalents of $63.7 million and $267.4 million in debt (net of deferred financing costs). The Company had $50.0 million of unused borrowing capacity available under its revolving credit facility as of June 30, 2019

 

Presentation of Non-GAAP Measures

 

In addition to the results provided in accordance with GAAP throughout this press release, the Company has presented Adjusted EBITDA, which is a non-GAAP measurement.  Adjusted EBITDA represents earnings before interest, taxes, depreciation and amortization (“EBITDA”) adjusted for (i) non-operating income or expense, and (ii) the impact of certain non-cash, nonrecurring or other items that are included in net loss and EBITDA that we do not consider indicative of our ongoing operating performance. In particular, Adjusted EBITDA excludes the following from EBITDA:  impairment of intangible assets, management fees, IPO expenses, severance expenses, foreign currency translation, legal settlements and share-based compensation expense. We use Adjusted EBITDA for business planning purposes, in assessing our performance and determining the compensation of substantially all of our employees, including our executive officers, and in measuring our performance relative to that of our competitors.  We also believe that Adjusted EBITDA provides investors with useful information to understand our operating results and analyze financial and business trends on a period-to-period basis.  Adjusted EBITDA has important limitations as an analytical tool, however, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP.  Adjusted EBITDA is not intended to replace, and should not be considered superior to, the presentation of our financial results in accordance with GAAP.  Our definition of Adjusted EBITDA may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures.  Adjusted EBITDA is reconciled from the net loss as determined under GAAP in the attached table “Osmotica Pharmaceuticals plc GAAP to Non-GAAP Reconciliations.”

 

Forward Looking Statements

 

This press release includes statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” The Company’s actual results may vary significantly from the results anticipated in these forward-looking statements, which can generally be identified by the use of forward-looking terminology, including the terms “believes,” “expects,” “may,” “will,” “should,” “seeks,” “projects,” “approximately,” “intends,” “plans,” “estimates” or “anticipates,” or, in each case, their negatives or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. They include statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of current products and the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions, the continuation of historical trends, our ability to operate our business under our new capital and operating structure, and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and

 


 

capital resource needs.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; our dependence on a limited number of products; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; our ability to service our substantial debt; our ability to raise additional capital; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our dependence on our major customers; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

 

Conference Call

 

As previously announced, Osmotica management will host its second quarter 2019 conference call as follows:

 

Date

 

Thursday, August 8, 2019

 

 

 

Time

 

4:30 p.m. EDT

 

 

 

Toll free (U.S.)

 

(866) 672-5029

 

 

 

International

 

(409) 217-8312

 

 

 

Webcast (live and replay)

 

www.osmotica.com, under the “Investor & News” section

 

 

 

Conference call ID

 

2989975

 

The webcast will be archived for 30 days at the aforementioned URL.

 


 

About Osmotica Pharmaceuticals plc

 

Osmotica Pharmaceuticals plc is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. Our diversified product portfolio in the specialty neurology and women’s health therapeutic areas, together with our non-promoted complex formulations of generic drugs, form the foundation of our unwavering commitment to improve patients’ lives.

 

Osmotica has a late-stage development pipeline highlighted by two NDA candidates that recently completed Phase III clinical trials: arbaclofen ER for spasticity in multiple sclerosis patients and RVL-1201 for the treatment of acquired blepharoptosis, or droopy eyelid.

 

Osmotica has operations in the United States, Argentina, and Hungary.

 

Investor and Media Relations for Osmotica Pharmaceuticals plc

Lisa M. Wilson

In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

 

-Financial tables follow-

 


 

Osmotica Pharmaceuticals plc

Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

June 30, 2019

 

 

 

 

 

(Unaudited)

 

December 31, 2018

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

63,737

 

$

70,834

 

Trade accounts receivable, net

 

68,142

 

56,424

 

Inventories, net

 

27,875

 

24,383

 

Prepaid expenses and other current assets

 

14,221

 

20,744

 

Total current assets

 

173,975

 

172,385

 

Property, plant and equipment, net

 

31,084

 

31,263

 

Operating lease assets

 

6,375

 

 

Intangibles, net

 

330,888

 

490,390

 

Goodwill

 

100,855

 

100,855

 

Other non-current assets

 

658

 

752

 

Total assets

 

$

643,835

 

$

795,645

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Trade accounts payable

 

$

18,917

 

$

24,870

 

Accrued liabilities

 

75,525

 

87,236

 

Current portion of long-term debt, net of deferred financing costs

 

991

 

1,774

 

Current portion of lease liability

 

2,206

 

 

Current portion of obligation under finance leases

 

131

 

119

 

Income taxes payable - current portion

 

134

 

394

 

Total current liabilities

 

97,904

 

114,393

 

Long-term debt, net of non-current deferred financing costs

 

267,366

 

266,803

 

Long-term portion of obligation under finance leases

 

101

 

138

 

Long-term portion of lease liability

 

4,383

 

 

Income taxes payable-long term portion

 

1,803

 

1,804

 

Deferred taxes

 

14,367

 

26,238

 

Total liabilities

 

385,924

 

409,376

 

Commitments and contingencies

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

Ordinary shares

 

525

 

525

 

Additional paid in capital

 

492,446

 

489,950

 

Accumulated deficit

 

(233,214

)

(102,360

)

Accumulated other comprehensive loss

 

(1,846

)

(1,846

)

Total shareholders’ equity

 

257,911

 

386,269

 

Total liabilities and shareholders’ equity

 

$

643,835

 

$

795,645

 

 


 

Osmotica Pharmaceuticals plc

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2019

 

2018

 

2019

 

2018

 

 

 

 

 

 

 

 

 

 

 

Net product sales

 

$

56,215

 

$

71,986

 

$

112,615

 

$

130,820

 

Royalty revenue

 

780

 

(211

)

1,501

 

752

 

Licensing and contract revenue

 

537

 

84

 

543

 

88

 

Total revenues

 

57,532

 

71,859

 

114,659

 

131,660

 

Cost of goods sold (inclusive of amortization of intangibles)

 

32,644

 

33,677

 

61,847

 

67,338

 

Gross profit

 

24,888

 

38,182

 

52,812

 

64,322

 

Selling, general and administrative expenses

 

25,511

 

16,676

 

47,168

 

33,838

 

Research and development expenses

 

5,360

 

8,867

 

15,125

 

18,941

 

Impairment of intangibles

 

125,766

 

 

125,766

 

 

Total operating expenses

 

156,637

 

25,543

 

188,059

 

52,779

 

Operating income (loss)

 

(131,749

)

12,639

 

(135,247

)

11,543

 

Interest expense and amortization of debt discount

 

4,552

 

5,241

 

9,052

 

10,084

 

Other non-operating expense (gain)

 

15

 

(309

)

(542

)

(446

)

Total other non-operating expense (gain)

 

4,567

 

4,932

 

8,510

 

9,638

 

Income (loss) before income taxes

 

(136,316

)

7,707

 

(143,757

)

1,905

 

Income tax benefit (expense)

 

11,662

 

(1,819

)

12,902

 

(624

)

Net income (loss)

 

$

(124,654

)

$

5,888

 

$

(130,855

)

$

1,281

 

Other comprehensive loss, net

 

 

 

 

 

 

 

 

 

Change in foreign currency translation adjustments

 

 

(722

)

 

(1,090

)

Comprehensive income (loss)

 

$

(124,654

)

$

5,166

 

$

(130,855

)

$

191

 

Income (loss) per share attributable to shareholders

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

$

(2.37

)

$

0.14

 

$

(2.49

)

$

0.03

 

Weighted average shares basic and diluted

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

52,519

 

42,856

 

52,519

 

42,856

 

 


 

Osmotica Pharmaceuticals plc

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2019

 

2018

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

Net income (loss)

 

$

(130,854

)

$

1,281

 

Adjustments to reconcile net income (loss) to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization

 

35,992

 

40,867

 

Share compensation

 

2,496

 

 

Loss on sale of fixed assets

 

53

 

 

Impairment of intangibles

 

125,766

 

 

Deferred income tax benefit

 

(11,870

)

(4,310

)

Bad debt provision

 

(157

)

(240

)

Amortization of deferred financing and loan origination fees

 

657

 

839

 

Change in operating assets and liabilities:

 

 

 

 

 

Trade accounts receivable, net

 

(11,561

)

(23,112

)

Inventories, net

 

(3,492

)

(9,079

)

Prepaid expenses and other current assets

 

6,524

 

5,800

 

Trade accounts payable

 

(5,953

)

(5,420

)

Accrued and other current liabilities

 

(11,760

)

(6,680

)

Net cash used in operating activities

 

(4,159

)

(54

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

Purchase of property, plant and equipment

 

(2,091

)

(2,181

)

Net cash used in investing activities

 

(2,091

)

(2,181

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

Payments to affiliates

 

 

(2

)

Payments on finance lease obligations

 

(64

)

(54

)

Proceeds from insurance financing loan

 

1,314

 

975

 

Repayment of insurance financing loan

 

(2,097

)

(195

)

Repayment of debt

 

 

(4,094

)

Net cash used in financing activities

 

(847

)

(3,370

)

Net change in cash and cash equivalents

 

(7,097

)

(5,605

)

Effect on cash of changes in exchange rate

 

 

(730

)

Cash and cash equivalents, beginning of period

 

70,834

 

34,743

 

Cash and cash equivalents, end of period

 

$

63,737

 

$

28,408

 

 


 

Osmotica Pharmaceuticals plc

GAAP to Non-GAAP Reconciliations

Adjusted EBITDA (Unaudited)

(in thousands)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2019

 

2018

 

2019

 

2018

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(124,654

)

$

5,888

 

$

(130,855

)

$

1,281

 

Interest expense and amortization of debt discount

 

4,552

 

5,241

 

9,052

 

10,084

 

Income tax (benefit) expense

 

(11,662

)

1,819

 

(12,902

)

624

 

Depreciation and amortization expense

 

17,999

 

20,452

 

35,992

 

40,867

 

 

 

 

 

 

 

 

 

 

 

EBITDA

 

(113,765

)

33,400

 

(98,713

)

52,856

 

 

 

 

 

 

 

 

 

 

 

Impairment of intangibles

 

125,766

 

 

125,766

 

 

Management fees

 

 

270

 

(43

)

520

 

IPO expenses

 

 

548

 

 

944

 

Severance expenses

 

181

 

40

 

362

 

484

 

FX translation

 

(11

)

 

211

 

 

Legal settlements

 

1,002

 

332

 

1,002

 

332

 

Share compensation expense

 

1,327

 

 

2,496

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted EBITDA

 

$

14,500

 

$

34,590

 

$

31,081

 

$

55,136