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Osmotica Pharmaceuticals plc Reports Third Quarter 2018 Results

BRIDGEWATER, N.J., Nov. 08, 2018 (GLOBE NEWSWIRE) -- 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 EBITDA1 for the third quarter was $25.8 million, compared to Adjusted EBITDA1 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 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   December 31, 2017 
   (Unaudited)   
       
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 
             
Thursday, November 8, 2018 - 16:01