EX-99.1 2 a18-39722_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Osmotica Pharmaceuticals plc Reports Third Quarter 2018 Results

 

Bridgewater, NJ, November 8, 2018 — Osmotica Pharmaceuticals plc (“Osmotica” or the “Company”) (Nasdaq: OSMT), a fully integrated biopharmaceutical company, today announced financial results for the three and nine months ended September 30, 2018.

 

Recent Business and Financial Highlights include:

 

Recent Business Highlights

 

·                  Completed an initial public offering (“IPO”) and concurrent private placement raising aggregate net proceeds of approximately $58.4 million, including the exercise in full of the underwriter’s over-allotment option.  $50 million of these proceeds were used to prepay debt;

 

·                  Completed enrollment of Osmotica’s 510 patient, double-blind, randomized (1:1:1) study to demonstrate the safety and efficacy of arbaclofen ER 40 mg/day and arbaclofen ER 80 mg/day versus placebo for the treatment of spasticity in patients with multiple sclerosis over a 12-week timeframe, and

 

·                  Commencing initial commercial launch of Osmolex ER™ (amantadine) extended release tablets (“Osmolex ER”) with a full-scale roll out planned for January 2019.

 

Third Quarter 2018 Financial Highlights

 

·                  Total revenues for the third quarter were $66.3 million, compared to $53.7 million in the third quarter of 2017;

 

·                  Net loss for the third quarter was $5.0 million compared to a net loss of $12.3 million in the third quarter of 2017;

 

·                  Adjusted EBITDA(1) for the third quarter was $25.8 million, compared to Adjusted EBITDA(1) of $24.0 million in the third quarter of 2017; and

 

·                  Cash and cash equivalents were $32.2 million, and debt (excluding deferred financing fees) was $321.9 million as of September 30, 2018.

 

“We are delighted to have completed our IPO, providing us with additional financial flexibility to advance our pipeline programs and explore new product and business development opportunities. We plan to make additional investments in our R&D programs and promotional

 


(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.”

 


 

activities surrounding Osmolex ER in the fourth quarter of 2018,” stated Brian Markison, Chief Executive Officer.

 

“Enrollment in our arbaclofen ER trial for spasticity in multiple sclerosis has been completed. We believe that a positive result from this trial, combined with our existing clinical and pre-clinical data package, would enable us to complete the submission of our NDA during the second half of 2019.  We are also concurrently conducting a long-term safety trial for the 80mg/day regimen of arbaclofen ER, which aims to enroll 250 patients. If approved by the FDA, we intend to begin commercialization of arbaclofen ER as early as 2020.”

 

Third Quarter 2018 Financial Results

 

Total revenues for the three months ended September 30, 2018 was $66.3 million, compared to $53.7 million for the three months ended September 30, 2017.

 

Net product sales increased to $65.4 million for the three months ended September 30, 2018, compared to $54.7 million for the three months ended September 30, 2017.  The increase in product sales was primarily due to methylphenidate hydrochloride (“HCI”) extended-release (“ER”) tablets, which was approved and launched in the third quarter of 2017, and methylphenidate HCl ER 72 mg tablets (“M-72”), which was launched in the second quarter of 2018, partially offset by lower product sales from venlafaxine ER (“VERT”).

 

Selling, general and administrative expenses increased to $17.5 million in the third quarter of 2018, compared to $13.3 million in the third quarter of 2017.  The increase was primarily due to an expansion of our field force in early 2018, expenses associated with the launch of M-72 and pre-launch activities for Osmolex ER, and costs associated with the Company’s IPO.

 

Research and development expenses increased to $13.3 million in the third quarter of 2018, compared to $6.5 million in the third quarter of 2017, largely due to clinical trial costs of arbaclofen ER, as discussed above, and RVL-1201 for the treatment of blepharoptosis, or droopy eyelid, each of which is in Phase III clinical trials, together with additional headcount.

 

Interest expense and amortization of debt discount decreased to $5.3 million in the third quarter of 2018, compared to $7.3 million in the third quarter of 2017. The decrease in borrowing costs resulted from a refinancing that was completed in December 2017.

 

Net loss for the third quarter of 2018 was $5.0 million, compared to net loss of $12.3 million in the third quarter of 2017.

 

Adjusted EBITDA for the third quarter of 2018 was $25.8 million, compared to Adjusted EBITDA of $24.0 million for the third quarter of 2017.

 

For a full reconciliation of Adjusted EBITDA to the most comparable GAAP financial measure, please see the tables at the end of this press release.

 


 

Nine Month Ended September 30, 2018 Financial Results

 

Total revenues for the nine months ended September 30, 2018 were $198.0 million, compared to $169.4 million for the nine months ended September 30, 2017.

 

Net product sales increased to $196.3 million for the nine months ended September 30, 2018, compared to $162.9 million for the nine months ended September 30, 2017, primarily due to methylphenidate HCI ER, which was approved and launched in the third quarter of 2017, and M-72, which was launched in the second quarter of 2018, offset by lower product sales from VERT during the nine months ended September 30, 2018.

 

Selling, general and administrative expenses increased to $51.3 million for the nine months ended September 30, 2018, compared to $41.3 million in the nine months ended September 30, 2017. The increase reflects costs incurred for the Company’s IPO, sales force expenses related to the launch of M-72 and pre-launch activities related to Osmolex ER.

 

Research and development expenses increased to $32.5 million for the nine months ended September 30, 2018, compared to $18.2 million in the nine months ended September 30, 2017, largely due to clinical trial costs for arbaclofen ER and RVL-1201, as mentioned above.

 

Net loss for the nine months ended September 30, 2018 was $3.6 million, compared to net loss of $42.3 million for the nine months ended September 30, 2017.

 

Adjusted EBITDA for the nine months ended September 30, 2018 was $80.9 million, compared to Adjusted EBITDA of $72.1 million for the nine months ended September 30, 2017.

 

For a full reconciliation of Adjusted EBITDA to the most comparable GAAP financial measure, please see the tables at the end of this press release.

 

Liquidity

 

As of September 30, 2018, Osmotica had cash and cash equivalents of $32.2 million and $321.9 million in debt (excluding deferred financing fees). The Company had $50 million of unused borrowing capacity available under its revolving credit facility as of September 30, 2018.

 

Presentation of Non-GAAP Measures

 

In addition to the results provided in accordance with GAAP throughout this press release, the Company has provided Adjusted EBITDA, which is a non-GAAP measurement.  Adjusted EBITDA represents earnings before interest, taxes, depreciation and amortization 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. Adjusted EBITDA excludes impairments, management fees, IPO expenses, consulting fees, severance expenses, acquired inventory step-up in costs of goods sold, legal and contractual settlements and litigation reserves and write-off of previously

 


 

acquired balances.  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 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 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 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 the prospectus dated October 17, 2018 related to the Company’s IPO 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 third quarter 2018 conference call as follows:

 

Date

 

Thursday, November 8, 2018

 

 

 

Time

 

4:30 p.m. EST

 

 

 

Toll free (U.S.)

 

(866) 672-5029

 

 

 

International

 

(409) 217-8312

 

 

 

Webcast (live and replay)

 

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

 

A replay of the conference call will be available for one week after the call’s completion by dialing (855) 859-2056 (US) or 404-537-3406 (International) and entering conference call ID 1018838.  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 in Phase III clinical trials: arbaclofen extended-release tablets for muscle spasticity in multiple sclerosis

 


 

patients and RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for the treatment of 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)

 

 

 

September 30, 2018

 

 

 

 

 

(Unaudited)

 

December 31, 2017

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

32,203

 

$

34,743

 

Trade accounts receivable, net

 

72,718

 

37,638

 

Inventories, net

 

25,594

 

16,947

 

Prepaid expenses and other current assets

 

18,802

 

25,814

 

Total current assets

 

149,317

 

115,142

 

Property, plant and equipment, net

 

31,301

 

31,410

 

Intangibles, net

 

521,239

 

585,389

 

Goodwill

 

152,816

 

152,816

 

Other non-current assets

 

799

 

942

 

Total assets

 

$

855,472

 

$

885,699

 

 

 

 

 

 

 

Liabilities and Partners’ Capital

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Trade accounts payable

 

$

27,861

 

$

36,070

 

Accrued liabilities

 

81,576

 

81,926

 

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

 

6,066

 

6,656

 

Current portion of obligation under capital leases

 

111

 

24

 

Total current liabilities

 

115,614

 

124,676

 

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

 

310,009

 

313,950

 

Long-term portion of obligation under capital leases

 

149

 

57

 

Income taxes payable

 

1,073

 

1,335

 

Deferred taxes

 

13,125

 

25,364

 

Other long-term liabilities

 

 

1,047

 

Total liabilities

 

439,970

 

466,429

 

Commitments and contingencies

 

 

 

 

 

Partners’ capital

 

 

 

 

 

Partners’ capital

 

417,374

 

419,903

 

Accumulated other comprehensive loss

 

(1,872

)

(633

)

Total partners’ capital

 

415,502

 

419,270

 

Total liabilities and partners’ capital

 

$

855,472

 

$

885,699

 

 


 

Osmotica Pharmaceuticals plc

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except unit and per unit data)

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2018

 

2017

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

Net product sales

 

$

65,444

 

$

54,678

 

$

196,264

 

$

162,903

 

Royalty revenue

 

903

 

(1,085

)

1,656

 

5,122

 

Licensing and contract revenue

 

(2

)

148

 

85

 

1,392

 

Total revenues

 

66,345

 

53,741

 

198,005

 

169,417

 

Cost of good sold (inclusive of amortization of intangibles)

 

32,012

 

21,464

 

99,150

 

77,364

 

Gross profit

 

34,333

 

32,277

 

98,855

 

92,053

 

Selling, general and administrative expenses

 

17,451

 

13,258

 

51,289

 

41,301

 

Research and development expenses

 

13,309

 

6,492

 

32,451

 

18,187

 

Impairment of intangible assets

 

6,173

 

30,748

 

6,173

 

72,448

 

Total operating expenses

 

36,933

 

50,498

 

89,913

 

131,936

 

Operating (loss) income

 

(2,600

)

(18,221

)

8,942

 

(39,883

)

Interest expense and amortization of debt discount

 

5,311

 

7,301

 

15,396

 

21,721

 

Other non-operating income, net

 

(434

)

(1,202

)

(881

)

(2,485

)

Total other non-operating expense, net

 

4,877

 

6,099

 

14,515

 

19,236

 

Loss before income taxes

 

(7,477

)

(24,320

)

(5,573

)

(59,119

)

Income tax benefit

 

2,489

 

12,047

 

1,999

 

16,786

 

Net loss

 

$

(4,988

)

$

(12,273

)

$

(3,574

)

$

(42,333

)

 

 

 

 

 

 

 

 

 

 

Loss per unit attributable to unitholders

 

 

 

 

 

 

 

 

 

Basic

 

$

(4.99

)

$

(12.27

)

$

(3.57

)

$

(42.31

)

Diluted

 

$

(4.99

)

$

(12.27

)

$

(3.57

)

$

(42.31

)

Weighted average units basic and diluted

 

 

 

 

 

 

 

 

 

Basic and diluted

 

1,000,515

 

1,000,515

 

1,000,515

 

1,000,515

 

 


 

Osmotica Pharmaceuticals plc

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2018

 

2017

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

Net loss

 

$

(3,574

)

$

(42,333

)

Adjustments to reconcile net loss to cash provided by operating activities

 

 

 

 

 

Depreciation and amortization

 

61,323

 

24,939

 

Loss on sale of fixed assets

 

13

 

 

Impairment of intangible assets

 

6,173

 

72,448

 

Deferred income tax benefit

 

(12,240

)

(32,786

)

Bad debt provision

 

(1,293

)

(1,052

)

Change in fair value of contingent consideration

 

 

182

 

Payment for contingent consideration

 

 

(1,991

)

Amortization of deferred financing and loan origination fees

 

1,261

 

1,645

 

Non-cash interest expense

 

 

3,961

 

Change in operating assets and liabilities

 

 

 

 

 

Trade accounts receivable, net

 

(33,821

)

18,809

 

Inventories, net

 

(8,647

)

(133

)

Prepaid expenses and other current assets

 

6,442

 

3,878

 

Other non-current assets

 

(2

)

 

Trade accounts payable

 

(9,063

)

(21,849

)

Accrued and other current liabilities

 

602

 

10,289

 

Net cash provided by operating activities

 

7,174

 

36,007

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

Proceeds from sale of fixed assets

 

10

 

 

Purchase of property, plant and equipment

 

(2,998

)

(7,126

)

Net cash used in investing activities

 

(2,988

)

(7,126

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

Distributions to partners

 

(2

)

(2,545

)

Contributions from partners

 

 

128

 

Payments on capital lease obligations

 

(82

)

(108

)

Proceeds from insurance financing loan

 

975

 

 

Repayment of insurance financing loan

 

(484

)

 

Debt repayment

 

(6,140

)

(5,252

)

Payment for contingent consideration

 

 

(8,509

)

Net cash used in financing activities

 

(5,733

)

(16,286

)

Net change in cash and cash equivalents

 

(1,547

)

12,595

 

Effect on cash of change in exchange rate

 

(993

)

524

 

Cash and cash equivalents, beginning of period

 

34,743

 

19,559

 

Cash and cash equivalents, end of period

 

$

32,203

 

$

32,678

 

 


 

Osmotica Pharmaceuticals plc

GAAP to Non-GAAP Reconciliations

Adjusted EBITDA (Unaudited)

(in thousands)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2018

 

2017

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(4,988

)

$

(12,273

)

$

(3,574

)

$

(42,333

)

Interest expense and amortization of debt discount

 

5,311

 

7,301

 

15,396

 

21,721

 

Income tax benefit

 

(2,489

)

(12,047

)

(1,999

)

(16,786

)

Depreciation and Amortization Expense

 

20,457

 

9,769

 

61,323

 

24,939

 

 

 

 

 

 

 

 

 

 

 

EBITDA

 

18,291

 

(7,250

)

71,146

 

(12,459

)

 

 

 

 

 

 

 

 

 

 

Impairment of intangible assets

 

6,173

 

30,748

 

6,173

 

72,448

 

Management Fees

 

250

 

250

 

770

 

750

 

IPO expenses

 

1,038

 

 

1,982

 

 

Consulting Fees

 

 

138

 

 

414

 

Severance expenses

 

 

42

 

484

 

123

 

Acquired Inventory Step-up in cost of goods sold

 

 

 

 

9,175

 

Legal and contractual settlements and litigation reserves

 

 

 

332

 

1,052

 

Write off of previously acquired balances

 

 

 

 

578

 

Adjusted EBITDA

 

$

25,752

 

$

23,928

 

$

80,887

 

$

72,081