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8-K - 8-K - Horizon Therapeutics Public Ltd Cod75917d8k.htm

Exhibit 99.1

 

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Horizon Pharma plc Announces Exceptional Third-Quarter 2015 Financial Results and

Significantly Raises Full-Year 2015 Sales and Adjusted EBITDA Guidance

— Net Sales of $226.5 Million, Up 202 Percent —

— Adjusted EBITDA of $131.1 Million; GAAP Net Income of $3.3 Million —

— Adjusted Operating Cash Flow of $100.8 Million; GAAP Operating Cash Flow of $88.4 Million —

—$684.3 Million of Cash; Net Debt/LTM Adjusted EBITDA Leverage Ratio of 2.1x—

— Raises Full-Year 2015 Net Sales Guidance to $750 to $760 Million —

— Raises Full-Year Adjusted EBITDA Guidance to $350 to $360 Million —

DUBLIN, IRELAND – November 6, 2015 – Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced its third-quarter 2015 financial results today.

Quarterly Financial Highlights

 

(in millions except for per share amounts and percentages)    Q3 15      Q3 14      %
Change
     9M 15      9M 14     %
Change
 

Net sales

   $ 226.5       $ 75.1         202       $ 512.5       $ 193.1        165   

Net income (loss)

     3.3         2.1         57         15.5         (232.0     NM   

Adjusted non-GAAP net income

     117.0         19.4         503         203.4         46.2        340   

Adjusted EBITDA

     131.1         22.1         493         239.7         52.3        358   

Earnings (loss) per share—basic

   $ 0.02       $ 0.03         -33       $ 0.11       $ (3.17     NM   

Adjusted non-GAAP earnings per share—basic

     0.74         0.25         196         1.40         0.63        122   

Earnings (loss) per share—diluted

     0.02         0.02         —           0.10         (3.17     NM   

Adjusted non-GAAP earnings per share—diluted

     0.70         0.19         268         1.32         0.48        175   

“Our business fundamentals have never been better, we significantly exceeded expectations on net sales, adjusted EBITDA and adjusted diluted earnings per share and our cash flow generation continues to be very strong,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. “As a result, we are significantly raising our full-year 2015 net sales and adjusted EBITDA guidance. Additionally, our Phase 3 trial for ACTIMMUNE in Friedreich’s ataxia is more than 30 percent enrolled, on track to complete enrollment in the second quarter of 2016 and we continue to expect results by the end of 2016.”

Horizon Pharma Increases 2015 Full-Year Guidance

 

     Prior Guidance      New Guidance  

Net sales

   $ 660 to $680 million       $ 750 to $760 million   

Adjusted EBITDA

   $ 265 to $280 million       $ 350 to $360 million   

 

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Third-Quarter and Nine-Month 2015 Net Sales Results

 

(in millions except for percentages)    Q3 15      Q3 14      %
Change
     9M 15      9M 14      %
Change
 

Primary Care

   $ 147.6       $ 66.0         124       $ 341.2       $ 174.1         96   

DUEXIS®

     56.9         22.8         150         130.0         54.5         139   

VIMOVO®

     46.8         43.2         8         119.6         119.6         0   

PENNSAID® 2% (1)

     43.9         —           NM         91.6         —           NM   

Orphan

     66.1         2.7         2343         139.6         2.7         NM   

ACTIMMUNE® (2)

     28.7         2.7         962         79.4         2.7         NM   

RAVICTI® (3)

     33.4         —           NM         52.4         —           NM   

BUPHENYL® (3)

     4.0         —           NM         7.8         —           NM   

Specialty

     12.8         6.4         98         31.7         16.3         94   

RAYOS®

     11.7         5.7         106         29.2         12.9         126   

LODOTRA®

     1.1         0.7         36         2.5         3.4         -27   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total net sales

   $ 226.5       $ 75.1         202       $ 512.5       $ 193.1         165   

 

(1) PENNSAID 2% was acquired on October 17, 2014. (2) ACTIMMUNE was acquired on September 19, 2014. (3) RAVICTI and BUPHENYL were acquired on May 7, 2015.

 

    Third-quarter 2015 net sales of $226.5 million increased 202 percent compared to the third quarter of 2014 and 31 percent sequentially compared to the second quarter of 2015. This was driven by strong growth in each of Horizon’s business units: primary care, orphan and specialty, as well as the addition of new medicines to the orphan and primary care business units.

 

    Orphan Business Unit: ACTIMMUNE sales of $28.7 million increased 11 percent sequentially compared to the second quarter of 2015. RAVICTI and BUPHENYL sales in the third quarter were $33.4 million and $4.0 million, respectively. The European Medicines Agency (EMA) adopted a positive opinion in September recommending a centralized marketing authorization for RAVICTI for use as an adjunctive therapy for Urea Cycle Disorders (UCDs). Horizon expects European approval for RAVICTI by the end of 2015 with the commercial launch expected in 2017. The orphan commercial organization continues to drive awareness of ACTIMMUNE and RAVICTI with both patients and physicians, and new patients continue to be steadily added to each medicine. In addition, enrollment in the STEADFAST Phase 3 trial for ACTIMMUNE in Friedreich’s ataxia is more than 30 percent completed, and trial results are expected by the end of 2016.

 

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    Primary Care Business Unit: DUEXIS sales of $56.9 million increased 150 percent compared to the third quarter of 2014 and 29 percent sequentially compared to the second quarter of 2015. VIMOVO sales of $46.8 million increased 8 percent compared to the third quarter of 2014 and 18 percent sequentially compared to the second quarter of 2015. PENNSAID 2% sales of $43.9 million increased 49 percent sequentially compared to second quarter 2015. Total prescriptions for the primary care business unit increased double digits sequentially compared to the second quarter of 2015, driven by differentiated clinical benefits and strong sales and marketing execution.

 

    Specialty Business Unit: RAYOS sales of $11.7 million increased 106 percent compared to the third quarter of 2014 and 13 percent sequentially compared to the second quarter of 2015, as total prescriptions continue to accelerate. LODOTRA sales of $1.1 million increased 36 percent compared to the third quarter of 2014.

Third-Quarter 2015 Financial Results

Note: For additional detail and reconciliation of these non-GAAP amounts to the most directly comparable GAAP financial measures, please refer to the detailed tables at the end of this release.

 

     Q3 2015     Q3 2014  
(in millions, except per share amounts)    U.S. GAAP      Adjustments     Non-GAAP     U.S. GAAP     Adjustments     Non-GAAP  

Net sales

   $ 226.5       $ —        $ 226.5      $ 75.1      $ —        $ 75.1   

Gross profit

     165.3         43.4        208.7        61.5        4.3        65.8   

Research and development

     13.1         (4.2     8.9        4.2        (0.4     3.8   

Sales and marketing

     52.0         (7.2     44.8        31.1        (1.7     29.4   

General and administrative

     54.5         (31.2     23.3        38.1        (30.6     7.5   

Total operating expenses

     119.6         (42.6     77.0        73.4        (32.7     40.7   

Interest expense, net

     20.3         (5.5     14.8        5.2        (2.4     2.8   

Bargain purchase gain

     —           —          —          22.2        (22.2     —     

Other expense, net

     0.1         —          0.1        3.2        (3.2     —     

Expense (benefit) for income taxes

     22.0         (22.2     (0.2     (3.0     3.0        —     

Net income

     3.3         113.7        117.0        2.1        17.3        19.4   

EBITDA (1)

     99.0         32.1        131.1        15.1        7.0        22.1   

Earnings per share—basic

   $ 0.02       $ 0.72      $ 0.74      $ 0.03      $ 0.22      $ 0.25   

Earnings per share—diluted

   $ 0.02       $ 0.68      $ 0.70      $ 0.02      $ 0.17      $ 0.19   

 

(1) EBITDA is a non-GAAP measure.

 

    Under U.S. generally accepted accounting principles (GAAP) in the third quarter of 2015, the gross profit ratio was 73.0 percent compared to 81.8 percent in the third quarter of 2014. The adjusted gross profit ratio in the third quarter of 2015 was 92.1 percent compared to 87.6 percent in the third quarter of 2014.

 

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    On a GAAP basis in the third quarter of 2015, total operating expenses were 52.8 percent of sales, research & development (R&D) expenses were 5.8 percent of sales, sales & marketing (S&M) expenses were 22.9 percent of sales and general & administration (G&A) expenses were 24.1 percent of sales. Adjusted total operating expenses in the third quarter of 2015 were 34.0 percent of sales, adjusted R&D expenses were 3.9 percent of sales, adjusted S&M expenses were 19.8 percent of sales and adjusted G&A expenses were 10.3 percent of sales. S&M expenses are expected to increase in the fourth quarter as the company further expands its sales and marketing efforts to support continued strong growth.

 

    On a GAAP basis in the third quarter of 2015, net income was $3.3 million compared to $2.1 million in the third quarter of 2014. Adjusted net income in the third quarter of 2015 was $117.0 million, or 51.7 percent of sales, compared to $19.4 million, or 25.8 percent of sales, in the third quarter of 2014.

 

    On an unadjusted basis in the third quarter of 2015, EBITDA was $99.0 million. Adjusted EBITDA in the third quarter of 2015 was $131.1 million, or 57.9 percent of sales, compared to $22.1 million, or 29.4 percent of sales, in the third quarter of 2014.

 

    On a GAAP basis in the third quarter of both 2015 and 2014, diluted earnings per share were $0.02. Adjusted diluted earnings per share in the third quarter of 2015 were $0.70, representing growth of 268 percent compared to the third quarter of 2014 diluted earnings per share of $0.19. Weighted average shares outstanding used for calculating earnings per share in the third quarter of 2015 were 159.0 million and 166.8 million for basic and diluted earnings per share, respectively.

Cash Flow Statement and Balance Sheet Highlights

 

    On a GAAP basis in the third quarter of 2015, operating cash flow was $88.4 million. Adjusted operating cash flow in the third quarter of 2015 was $100.8 million, which excludes cash payments for transaction-related costs.

 

    The company had cash and cash equivalents of $684.3 million as of September 30, 2015, an increase of $17.2 million from June 30, 2015. This increase in the cash balance is significantly less than the cash flow from operations during the third quarter primarily due to $71.8 million used to acquire shares of Depomed, Inc. during the quarter.

 

    Total principal amount of debt outstanding was $1.274 billion as of September 30, 2015, which is comprised of $475 million in 6.625 percent senior notes due 2023, $399 million in senior secured term loans due 2021, and $400 million of 2.5 percent exchangeable senior notes due 2022.

 

   

As of September 30, 2015, the company had a total debt to last 12 months (LTM) adjusted EBITDA leverage ratio of 4.6x and a net debt to LTM adjusted EBITDA leverage ratio of 2.1x.

 

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Conference Call

At 8 a.m. EST / 1 p.m. IST today, the Company will host a live conference call and webcast to review its financial and operating results and provide a general business update.

U.S. Dial-In Number: +1 888.338.8373

International Dial-In Number: +1 973.872.3000

Passcode: 62744788

The live webcast and a replay may be accessed by visiting Horizon’s website at http://ir.horizon-pharma.com. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

A replay of the conference call will be available approximately two hours after the call and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855.859.2056

Replay International Dial-In Number: +1 404.537.3406

Passcode: 62744788

About Horizon Pharma plc

Horizon Pharma plc is a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The Company markets seven medicines through its orphan, primary care and specialty business units. Horizon’s global headquarters are in Dublin, Ireland. For more information, please visit www.horizonpharma.com. Follow @HZNPplc on Twitter or view careers on our LinkedIn page.

Note Regarding Use of Non-GAAP Financial Measures

EBITDA, or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA are used and provided by Horizon as non-GAAP financial measures. Horizon provides certain other financial measures such as adjusted net income, adjusted net income per share, adjusted gross profit and gross profit ratio, adjusted operating and other expenses and adjusted cash from operations, each of which include adjustments to GAAP figures. Adjustments to Horizon’s GAAP figures as well as EBITDA exclude acquisition transaction related expenses, loss on debt extinguishment, as well as non-cash items such as share-based compensation, depreciation and amortization, royalty accretion, non-cash interest expense, and other non-cash adjustments. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Horizon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected 2015 financial results and trends. In addition, these non-GAAP financial measures are among the indicators Horizon’s management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial

 

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measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Horizon has not provided reconciliation of an expected adjusted EBITDA outlook to an expected net income (loss) outlook because certain items that are a component of net income (loss) cannot be reasonably projected, either due to the significant impact of changes in Horizon’s stock price on share-based compensation, the variability associated with acquisition-related expenses due to timing and other factors.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to Horizon’s expected full-year 2015 net sales and adjusted EBITDA guidance, the status of Horizon’s business fundamentals, expected financial performance in future periods, expected timing of clinical and regulatory events; and other statements that are not historical facts. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that Horizon’s actual full-year 2015 financial and operating results may differ from its expectations; Horizon Pharma’s ability to grow net sales from existing products; the availability of coverage and adequate reimbursement and pricing from government and third-party payors and risks relating to the success of Horizon’s patient support program; risks associated with clinical development and regulatory approvals; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon Pharma operates; and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Horizon’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”). Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information.

Investors:

John B. Thomas

Executive Vice President, Corporate Strategy and Investor Relations

jthomas@horizonpharma.com

Tina Ventura

Vice President, Investor Relations

tventura@horizonpharma.com

U.S. Media Contact:

Geoff Curtis

Group Vice President, Corporate Communications

gcurtis@horizonpharma.com

Ireland Media Contact:

Ray Gordon

Gordon MRM

ray@gordonmrm.ie

 

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Horizon Pharma plc

Consolidated Statements of Operations (Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended Sept. 30,     Nine Months Ended Sept. 30,  
     2015     2014     2015     2014  

REVENUES:

        

Net sales

   $ 226,544      $ 75,126      $ 512,506      $ 193,114   

Cost of goods sold

     61,250        13,644        151,929        46,073   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     165,294        61,482        360,577        147,041   
  

 

 

   

 

 

   

 

 

   

 

 

 

OPERATING EXPENSES:

        

Research and development

     13,073        4,223        28,176        10,601   

Sales and marketing

     51,973        31,111        157,092        86,932   

General and administrative

     54,516        38,109        157,986        66,982   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     119,562        73,443        343,254        164,515   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss)

     45,732        (11,961     17,323        (17,474
  

 

 

   

 

 

   

 

 

   

 

 

 

OTHER (EXPENSE) INCOME, NET:

        

Interest expense, net

     (20,300     (5,194     (49,780     (13,608

Foreign exchange loss

     (86     (2,754     (1,010     (3,076

Bargain purchase gain

     —          22,171        —          22,171   

Loss on derivative fair value

     —          —          —          (214,995

Loss on induced conversion of debt and debt extinguishment

     —          —          (77,624     —     

Other expense, net

     (90     (3,241     (10,159     (8,241
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other (expense) income, net

     (20,476     10,982        (138,573     (217,749
  

 

 

   

 

 

   

 

 

   

 

 

 

Profit (loss) before expense (benefit) for income taxes

     25,256        (979     (121,250     (235,223

EXPENSE (BENEFIT) FOR INCOME TAXES

     21,979        (3,042     (136,788     (3,267
  

 

 

   

 

 

   

 

 

   

 

 

 

NET INCOME (LOSS)

   $ 3,277      $ 2,063      $ 15,538      $ (231,956
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings (loss) per share—basic

   $ 0.02      $ 0.03      $ 0.11      $ (3.17
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding—basic

     159,035,580        78,392,971        145,208,252        73,109,603   
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings (loss) per share—diluted

   $ 0.02      $ 0.02      $ 0.10      $ (3.17
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding—diluted

     166,830,800        85,687,267        154,005,671        73,109,603   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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Horizon Pharma plc

Consolidated Balance Sheets (Unaudited)

(in thousands, except share data)

 

     As of  
     Sept. 30, 2015     Dec. 31, 2014  
ASSETS     

CURRENT ASSETS:

    

Cash and cash equivalents

   $ 684,286      $ 218,807   

Restricted cash

     860        738   

Accounts receivable, net

     221,091        73,915   

Inventories, net

     17,729        16,865   

Prepaid expenses and other current assets

     16,466        14,370   

Deferred tax assets, net

     13,196        1,530   
  

 

 

   

 

 

 

Total current assets

     953,628        326,225   
  

 

 

   

 

 

 

Property and equipment, net

     10,380        7,241   

Developed technology, net

     1,650,553        696,963   

In-process research and development

     66,000        66,000   

Other intangible assets, net

     7,263        7,870   

Goodwill

     259,167        —     

Long term investments

     42,413        —     

Deferred tax assets, net, non-current

     —          18,761   

Other assets

     9,514        11,564   
  

 

 

   

 

 

 

TOTAL ASSETS

   $ 2,998,918      $ 1,134,624   
  

 

 

   

 

 

 
LIABILITIES AND SHAREHOLDERS’ EQUITY     

CURRENT LIABILITIES:

    

Convertible debt, net

   $ —        $ 48,334   

Long-term debt—current portion

     4,000        —     

Accounts payable

     62,083        21,011   

Accrued expenses

     84,364        46,625   

Accrued trade discounts and rebates

     124,378        76,115   

Accrued royalties—current portion

     45,411        25,325   

Deferred revenues—current portion

     1,353        1,261   

Deferred tax liabilities, net

     —          721   
  

 

 

   

 

 

 

Total current liabilities

     321,589        219,392   
  

 

 

   

 

 

 

LONG-TERM LIABILITIES:

    

Exchangeable notes, net

     278,990        —     

Long-term debt, net, net of current

     858,021        297,169   

Accrued royalties, net of current

     125,272        48,887   

Deferred revenues, net of current

     9,570        8,144   

Deferred tax liabilities, net, non-current

     142,702        19,570   

Other-long term liabilities

     4,436        1,258   
  

 

 

   

 

 

 

Total long-term liabilities

     1,418,991        375,028   
  

 

 

   

 

 

 

COMMITMENTS AND CONTINGENCIES

    

SHAREHOLDERS’ EQUITY:

    

Ordinary shares, $0.0001 nominal value; 300,000,000 shares authorized; 159,651,736 and 124,425,853 issued at September 30, 2015 and December 31, 2014 respectively, and 159,267,370 and 124,041,487 outstanding at September 30, 2015 and December 31, 2014, respectively.

     16        13   

Treasury stock, 384,366 ordinary shares at September 30, 2015 and December 31, 2014

     (4,585     (4,585

Additional paid-in capital

     2,000,292        1,269,858   

Accumulated other comprehensive loss

     (32,204     (4,363

Accumulated deficit

     (705,181     (720,719
  

 

 

   

 

 

 

Total shareholders’ equity

     1,258,338        540,204   
  

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

   $ 2,998,918      $ 1,134,624   
  

 

 

   

 

 

 

 

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Horizon Pharma plc

Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

     Three Months Ended Sept. 30,     Nine Months Ended Sept. 30,  
     2015     2014     2015     2014  

CASH FLOWS FROM OPERATING ACTIVITIES:

        

Net income (loss)

   $ 3,277      $ 2,063      $ 15,538      $ (231,956

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

        

Depreciation and intangible amortization expense

     43,285        6,826        94,025        17,662   

Share-based compensation

     24,914        4,024        56,253        10,111   

Royalty accretion

     6,551        2,664        13,571        5,617   

Royalty liability remeasurement

     —          —          14,277        13,033   

Bargain purchase gain

     —          (22,171     —          (22,171

Loss on derivative revaluation

     —          —          —          214,995   

Loss on induced conversions of debt and debt extinguishment

     —          —          21,581        —     

Amortization of debt discount and deferred financing costs

     5,480        2,421        13,328        7,087   

Foreign exchange loss

     86        2,754        1,010        3,076   

Other

     44        11        127        11   

Changes in operating assets and liabilities:

        

Accounts receivable

     (38,203     (16,198     (135,370     (52,033

Inventories

     2,264        639        12,819        129   

Prepaid expenses and other current assets

     (4,180     120        417        (2,091

Accounts payable

     36,609        4,575        38,213        10,555   

Accrued trade discounts and rebates

     (12,460     16,644        35,136        46,113   

Accrued expenses and accrued royalties

     (5,440     823        11,052        796   

Deferred revenues

     (635     (686     2,143        (324

Deferred income taxes

     24,859        (3,046     (134,014     (3,278

Payment of original issue discount upon repayment of 2014 Term Loan Facility

     —          —          (3,000     —     

Other non-current assets and liabilities

     1,932        3        2,122        138   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by operating activities

     88,383        1,466        59,228        17,470   
  

 

 

   

 

 

   

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

        

Payments for acquisitions, net of cash acquired

     —          (179,220     (1,022,361     (179,220

Proceeds from liquidation of available-for-sale investments

     —          —          64,623        —     

Purchases of long-term investments

     (71,813     —          (71,813     —     

Purchases of property and equipment

     (2,233     (800     (4,514     (1,837

Change in restricted cash

     (260     —          (122     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (74,306     (180,020     (1,034,187     (181,057
  

 

 

   

 

 

   

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

        

Net proceeds from the issuance of Exchangable Senior Notes

     —          —          387,181        —     

Net proceeds from the issuance of 2023 Senior Notes

     —          —          462,340        —     

Net proceeds from the 2015 Term Loan Facility

     (213     —          391,506        —     

Net proceeds from the 2014 Term Loan Facility

     —          286,966        —          286,966   

Repayment of the 2015 Term Loan Facility

     (1,000     —          (1,000     —     

Repayment of the 2014 Term Loan Facility

     —          —          (297,000     —     

Net proceeds from the issuance of ordinary shares

     —          —          475,627        —     

Proceeds from the issuance of common stock in connection with warrant exercises

     3,431        2,090        18,124        33,262   

Proceeds from the issuance of common stock through ESPP programs

     —          —          1,541        649   

Proceeds from the issuance of common stock in connection with stock option exercises

     714        107        4,602        1,704   

Payment of employee withholding taxes relating to share-based awards

     (378     —          (2,334     —     

Proceeds from the settlement of capped call transactions

     —          9,385        —          9,385   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by financing activities

     2,554        298,548        1,440,587        331,966   
  

 

 

   

 

 

   

 

 

   

 

 

 

Effect of foreign exchange rate changes on cash

     598        (64     (149     (78
  

 

 

   

 

 

   

 

 

   

 

 

 

NET INCREASE IN CASH AND CASH EQUIVALENTS

     17,229        119,930        465,479        168,301   

CASH AND CASH EQUIVALENTS, beginning of the period

     667,057        128,851        218,807        80,480   
  

 

 

   

 

 

   

 

 

   

 

 

 

CASH AND CASH EQUIVALENTS, end of the period

   $ 684,286      $ 248,781      $ 684,286      $ 248,781   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

9


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Horizon Pharma plc

Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Income (Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended Sept. 30,     Nine Months Ended Sept. 30,  
     2015     2014     2015     2014  
     (Unaudited)     (Unaudited)  

Adjusted Non-GAAP Net Income:

        

GAAP Net Income (Loss)

   $ 3,277      $ 2,063      $ 15,538      $ (231,956

Non-GAAP Adjustments:

        

Remeasurement of royalties for products acquired through business combinations

     —          —          14,277        13,033   

Acquisition related costs

     14,498        31,477        64,841        45,651   

Loss on derivative revaluation

     —          —          —          214,995   

Loss on induced conversion of debt and debt extinguishment

     —          —          77,624        —     

Bargain purchase gain

     —          (22,171     —          (22,171

Amortization and accretion:

        

Intangible amortization expense

     41,707        6,413        91,217        16,469   

Amortization of debt discount and deferred financing costs

     5,480        2,421        13,328        7,087   

Accretion of royalty liabilities

     6,551        2,664        13,571        5,617   

Amortizaton of inventory step-up adjustment

     4,140        1,540        10,635        1,540   

Share-based compensation

     26,457        4,024        57,796        10,111   

Depreciation expense

     1,578        413        2,808        1,193   

Royalties for products acquired through business combinations (1)

     (8,854     (6,366     (20,890     (12,062
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of pre-tax non-GAAP adjustments

     91,557        20,415        325,207        281,463   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income tax adjustments (2)

     22,178        (3,042     (137,328     (3,267
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     113,735        17,373        187,879        278,196   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Non-GAAP Net Income

   $ 117,012      $ 19,436      $ 203,417      $ 46,240   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Non-GAAP Earnings Per Share:

        

Weighted average shares—Basic

     159,035,580        78,392,971        145,208,252        73,109,603   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Non-GAAP Earnings Per Share—Basic:

        

GAAP earnings (loss) per share—Basic

   $ 0.02      $ 0.03      $ 0.11      $ (3.17

Non-GAAP adjustments

     0.72        0.22        1.29        3.80   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Non-GAAP earnings per share—Basic

   $ 0.74      $ 0.25      $ 1.40      $ 0.63   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares—Diluted

        

Weighted average shares—Basic

     159,035,580        78,392,971        145,208,252        73,109,603   

Ordinary share equivalents

     7,795,220        35,258,496        8,797,419        35,577,854   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares—Diluted

     166,830,800        113,651,467        154,005,671        108,687,457   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Non-GAAP Net Income—Diluted

        

Adjusted Non-GAAP Net Income

   $ 117,012      $ 19,436      $ 203,417      $ 46,240   

Add: Convertible debt interest expense, net of taxes

     —          1,875        —          5,625   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Non-GAAP Net Income—Diluted

   $ 117,012      $ 21,311      $ 203,417      $ 51,865   
  

 

 

   

 

 

   

 

 

   

 

 

 

GAAP earnings (loss) per share—Diluted

   $ 0.02      $ 0.02      $ 0.10      $ (3.17

Non-GAAP adjustments

     0.68        0.20        1.22        3.81   

Diluted earnings per share effect of ordinary share equivalents

     —          (0.03     —          (0.16
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Non-GAAP earnings per share—Diluted

   $ 0.70      $ 0.19      $ 1.32      $ 0.48   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(1) Royalties for products acquired through business combinations relate to VIMOVO, ACTIMMUNE, RAVICTI and BUPHENYL.
(2) Adjustments to convert the income tax benefit/expense to the estimated amount of taxes that are payable in cash.

 

 

10


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Horizon Pharma plc

Additional GAAP to Non-GAAP Reconciliations

EBITDA, Gross Profit and Operating Cash Flow (Unaudited)

(in thousands, except percentages)

 

     Three Months Ended Sept. 30,     Nine Months Ended Sept. 30,  
     2015     2014     2015     2014  
     (Unaudited)     (Unaudited)  

EBITDA and Adjusted EBITDA:

        

GAAP Net Income (Loss)

   $ 3,277      $ 2,063      $ 15,538      $ (231,956

Depreciation

     1,578        413        2,808        1,193   

Amortization and accretion:

        

Intangible amortization expense

     41,707        6,413        91,217        16,469   

Accretion of royalty liabilities

     6,551        2,664        13,571        5,617   

Amortization of deferred revenue

     (490     (156     (753     (478

Amortizaton of inventory step-up adjustment

     4,140        1,540        10,635        1,540   

Interest expense, net (including amortization of debt discount and deferred financing costs)

     20,300        5,194        49,780        13,608   

Expense (benefit) for income taxes

     21,979        (3,042     (136,788     (3,267
  

 

 

   

 

 

   

 

 

   

 

 

 

EBITDA

   $ 99,042      $ 15,089      $ 46,008      $ (197,274
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP adjustments:

        

Remeasurement of royalties for products acquired through business combinations

     —          —          14,277        13,033   

Acquisition related costs

     14,498        31,477        64,841        45,651   

Loss on derivative revaluation

     —          —          —          214,995   

Loss on induced conversion and debt extinguishment

     —          —          77,624        —     

Bargain purchase gain

     —          (22,171     —          (22,171

Share-based compensation

     26,457        4,024        57,796        10,111   

Royalties for products acquired through business combinations (1)

     (8,854     (6,366     (20,890     (12,062
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of Non-GAAP adjustments

   $ 32,101      $ 6,964      $ 193,648      $ 249,557   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 131,143      $ 22,053      $ 239,656      $ 52,283   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Gross Profit:

        

GAAP net sales

   $ 226,544      $ 75,126      $ 512,506      $ 193,114   

GAAP cost of goods sold

     61,250        13,644        151,929        46,073   
  

 

 

   

 

 

   

 

 

   

 

 

 

GAAP gross profit

   $ 165,294      $ 61,482      $ 360,577      $ 147,041   
  

 

 

   

 

 

   

 

 

   

 

 

 

GAAP gross profit %

     73.0     81.8     70.4     76.1

Non-GAAP Gross Profit:

        

GAAP gross profit

   $ 165,294      $ 61,482      $ 360,577      $ 147,041   

Non-GAAP gross profit adjustments:

        

Remeasurement of royalties for products acquired through business combinations

     —          —          14,277        13,033   

Intangible amortization expense (COGS only)

     41,506        6,386        90,610        16,442   

Accretion of royalty liabilities

     6,551        2,664        13,571        5,617   

Amortizaton of inventory step-up adjustment

     4,140        1,540        10,635        1,540   

Depreciation (COGS only)

     65        90        268        264   

Royalties for products acquired through business combinations (1)

     (8,854     (6,366     (20,890     (12,062
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of Non-GAAP adjustments

   $ 43,408      $ 4,314      $ 108,471      $ 24,834   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP gross profit

   $ 208,702      $ 65,796      $ 469,047      $ 171,875   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP gross profit %

     92.1     87.6     91.5     89.0

Adjusted Operating Cash Flow:

        

GAAP cash provided by operating activities

   $ 88,383      $ 1,466      $ 59,228      $ 17,470   

Cash payments of acquistion related costs

     12,464        34,142        49,152        43,150   

Cash payments for induced debt conversion

     —          —          10,472        —     

Cash payment for debt extinguishment

     —          —          45,367        —     

Payment of original issue discount on debt extinguishment

     —          —          3,000        —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted operating cash flow

   $ 100,847      $ 35,608      $ 167,219      $ 60,620   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(1) Royalties for products acquired through business combinations relate to VIMOVO, ACTIMMUNE, RAVICTI and BUPHENYL.

 

 

11


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Horizon Pharma plc

Certain Income Statement Line Items—Non-GAAP Adjusted

For the Three Months Ended September 30, 2015

(Unaudited)

 

    Sales     COGS     Research &
Development
    Sales &
Marketing
    General &
Administrative
    Interest
Expense
    Loss on Induced
Debt Conversion
& Debt
Extinguishment
    Other
(Income) Expense
    Income Tax
(Benefit) Expense
    Total  

Non-GAAP Adjustments (in thousands):

                   

Acquisition related costs(1)

    —          —          2,158        —          12,340        —          —          —          —          14,498   

Amortization and accretion:

                   

Intangible amortization expense(2)

    —          41,505        —          202        —          —          —          —          —          41,707   

Amortization of debt discount and deferred financing costs(3)

    —          —          —          —          —          5,480        —          —          —          5,480   

Accretion of royalty liability(4)

    —          6,551        —          —          —          —          —          —          —          6,551   

Amortization of inventory step-up adjustment(5)

    —          4,140        —          —          —          —          —          —          —          4,140   

Stock-based compensation(6)

    —          —          2,042        7,035        17,380        —          —          —          —          26,457   

Depreciation expense(7)

    —          65        —          —          1,513        —          —          —          —          1,578   

Royalties for products acquired through business combinations(8)

    —          (8,854     —          —          —          —          —          —          —          (8,854

Income tax adjustments(9)

    —          —          —          —          —          —          —          —          22,178        22,178   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

    —          43,407        4,200        7,237        31,233        5,480        —          —          22,178        113,735   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Horizon Pharma plc

Certain Income Statement Line Items—Non-GAAP Adjusted

For the Three Months Ended September 30, 2014

(Unaudited)

 

    Sales     COGS     Research &
Development
    Sales &
Marketing
    General &
Administrative
    Interest
Expense
    Derivative
Loss
    Other
(Income) Expense
    Income Tax
(Benefit) Expense
    Total  

Non-GAAP Adjustments (in thousands):

                   

Bargain purchase gain(10)

    —          —          —          —          —          —          —          (22,171     —          (22,171

Acquisition related costs(1)

    —          —          —          —          28,255        —          —          3,222        —          31,477   

Amortization and accretion:

                   

Intangible amortization expense(2)

    —          6,386        —          27        —          —          —          —          —          6,413   

Amortization of debt discount and deferred financing costs(3)

    —          —          —          —          —          2,421        —          —          —          2,421   

Accretion of royalty liability(4)

    —          2,664        —          —          —          —          —          —          —          2,664   

Amortization of inventory step-up adjustment(5)

    —          1,540        —          —          —          —          —          —          —          1,540   

Stock-based compensation(6)

    —          —          354        1,654        2,016        —          —          —          —          4,024   

Depreciation expense(7)

    —          90        —          —          323        —          —          —          —          413   

Royalties for products acquired through business combinations(8)

    —          (6,366     —          —          —          —          —          —          —          (6,366

Income tax adjustments(9)

    —          —          —          —          —          —          —          —          (3,042     (3,042
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

    —          4,314        354        1,681        30,594        2,421        —          (18,949     (3,042     17,373   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

12


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Horizon Pharma plc

Certain Income Statement Line Items—Non-GAAP Adjusted

For the Nine Months Ended September 30, 2015

(Unaudited)

 

    Sales     COGS     Research &
Development
    Sales &
Marketing
    General &
Administrative
    Interest
Expense
    Loss on Induced
Debt Conversion
& Debt
Extinguishment
    Other
(Income) Expense
    Income Tax
(Benefit) Expense
    Total  

Non-GAAP Adjustments (in thousands):

                   

Loss on induced conversion and debt extinguistment(11)

    —          —          —          —          —          —          77,624        —          —          77,624   

Acquisition related costs(1)

    —          23        2,252        —          52,566        —          —          10,000        —          64,841   

Amortization and accretion:

                   

Intangible amortization expense(2)

    —          90,609        —          608        —          —          —          —          —          91,217   

Amortization of debt discount and deferred financing costs(3)

    —          —          —          —          —          13,328        —          —          —          13,328   

Accretion of royalty liability(4)

    —          13,571        —          —          —          —          —          —          —          13,571   

Amortization of inventory step-up adjustment(5)

    —          10,635        —          —          —          —          —          —          —          10,635   

Remeasurement of royalties for products acquired through business combinations(12)

    —          14,277        —          —          —          —          —          —          —          14,277   

Stock-based compensation(6)

    —          —          4,712        15,571        37,513        —          —          —          —          57,796   

Depreciation expense(7)

    —          268        —          —          2,540        —          —          —          —          2,808   

Royalties for products acquired through business combinations(8)

    —          (20,890     —          —          —          —          —          —          —          (20,890

Income tax adjustments(9)

    —          —          —          —          —          —          —          —          (137,328     (137,328
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

    —          108,493        6,964        16,179        92,619        13,328        77,624        10,000        (137,328     187,879   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Horizon Pharma plc

Certain Income Statement Line Items—Non-GAAP Adjusted

For the Nine Months Ended September 30, 2014

(Unaudited)

 

    Sales     COGS     Research &
Development
    Sales &
Marketing
    General &
Administrative
    Interest
Expense
    Derivative
Loss
    Other
(Income) Expense
    Income Tax
(Benefit) Expense
    Total  

Non-GAAP Adjustments (in thousands):

                   

Bargain purchase gain(10)

    —          —          —          —          —          —          —          (22,171     —          (22,171

Loss on derivative revaluation(13)

    —          —          —          —          —          —          214,995        —          —          214,995   

Acquisition related costs(1)

    —          —          —          —          37,429        —          —          8,222        —          45,651   

Amortization and accretion:

                   

Intangible amortization expense(2)

    —          16,442        —          27        —          —          —          —          —          16,469   

Amortization of debt discount and deferred financing costs(3)

    —          —          —          —          —          7,087        —          —          —          7,087   

Accretion of royalty liability(4)

    —          5,617        —          —          —          —          —          —          —          5,617   

Amortization of inventory step-up adjustment(5)

    —          1,540        —          —          —          —          —          —          —          1,540   

Remeasurement of royalties for products acquired through business combinations(12)

    —          13,033        —          —          —          —          —          —          —          13,033   

Stock-based compensation(6)

    —          —          1,152        3,278        5,681        —          —          —          —          10,111   

Depreciation expense(7)

    —          270        —          —          923        —          —          —          —          1,193   

Royalties for products acquired through business combinations(8)

    —          (12,062     —          —          —          —          —          —          —          (12,062

Income tax adjustments(9)

    —          —          —          —          —          —          —          —          (3,267     (3,267
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

    —          24,840        1,152        3,305        44,033        7,087        214,995        (13,949     (3,267     278,196   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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NOTES FOR CERTAIN INCOME STATEMENT LINE ITEMS—NON-GAAP ADJUSTED

(in thousands)

 

(1) Expenses, including legal and consulting fees, incurred in connection with the Company’s acquisitions of Vidara Therapeutics International Public Limited Company (“Vidara”) and Hyperion Therapeutics, Inc. (“Hyperion”), and its proposed acquisition of Depomed Inc. (“Depomed”), have been excluded as non-recurring items.

 

(2) Intangible amortization expenses are associated with the Company’s intellectual property rights, developed technology and customer relationships of VIMOVO, LODOTRA, RAYOS, ACTIMMUNE, RAVICTI and BUPHENYL.

 

(3) Represents amortization of debt discount and deferred financing costs associated with the Company’s debt.

 

(4) Represents accretion expense associated with the ACTIMMUNE, VIMOVO, RAVICTI and BUPHENYL royalties for the three and nine months ended September 30, 2015, and represents accretion expense associated with the ACTIMMUNE and VIMOVO royalties for the three and nine months ended September 30, 2014.

 

(5) In connection with the Hyperion acquisition, the RAVICTI and BUPHENYL inventory was stepped up in value to $8,682 and during the three and nine months ended September 30, 2015, the Company recognized in cost of goods sold $4,140 and $7,481, respectively, of step-up inventory costs related to RAVICTI and BUPHENYL inventory sold. In connection with the Vidara acquisition, the ACTIMMUNE inventory was stepped up in value to $14,218 and during the third quarter of 2014, the Company recognized in cost of goods sold $1,540 of step-up inventory costs related to ACTIMMUNE. During the first quarter of 2015, the Company recognized in cost of goods sold the remaining $3,154 of step-up inventory costs related to ACTIMMUNE.

 

(6) Represents share-based compensation expense associated with the Company’s stock option, restricted stock unit, and performance stock unit grants to its employees and non-employees, its cash-settled long-term incentive program, and its employee stock purchase plan.

 

(7) Represents depreciation expense related to the Company’s property, equipment and leasehold improvements.

 

(8) Royalties of $8,854 and $20,890 were incurred during the three and nine months ended September 30, 2015, respectively, based on each period’s net sales for VIMOVO, ACTIMMUNE, RAVICTI and BUPHENYL. Royalties of $6,366 and $12,062 were incurred during the three and nine months ended September 30, 2014, respectively, based on each period’s net sales for VIMOVO and ACTIMMUNE.

 

(9) Represents adjustments to convert the income tax expense (benefit) to the estimated amount of taxes that are payable in cash.

 

(10) The bargain purchase gain of $22,171 was the result of the Vidara acquisition. Identifiable assets and liabilities of Vidara, including identifiable intangible assets, were recorded based on their estimated fair values as of the date of the closing of the acquisition. The excess of the fair value of the net assets acquired over the value of consideration was recorded as a bargain purchase gain.

 

(11) During the six months ended June 30, 2015, the Company recorded a loss on induced debt conversions of $77,624, which represented an early redemption payment of $45,366, the write-down of $21,581 in debt discount and deferred financing costs, $10,005 in additional exchange consideration to debt holders and $672 in expenses incurred in connection with the induced debt conversions. Following these induced debt conversions in the six months ended June 30, 2015, there were no convertible senior notes remaining outstanding.

 

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LOGO

 

(12) At the time of the Company’s acquisition of the rights to VIMOVO, ACTIMMUNE, RAVICTI and BUPHENYL, the Company estimated the fair value of contingent royalties payable to third parties using an income approach under the discounted cash flow method, which included revenue projections and other assumptions the Company made to determine the fair value. If the Company significantly over performs or underperforms against its original revenue projections or it becomes necessary to make changes to assumptions as a result of a triggering event, the Company is required to reassess the fair value of the contingent royalties payable. Any subsequent adjustments to fair value is recorded in the period such adjustment is made as either an increase or decrease to royalties payable, with a corresponding increase or decrease in cost of goods sold, in accordance with established accounting policies.

During the second quarter of 2015, the Company recorded a charge of $14,277 to cost of goods sold to increase the amount of the contingent royalty liabilities relating to VIMOVO and ACTIMMUNE. During the second quarter of 2014, the Company recorded a charge of $13,033 to cost of goods sold to increase the amount of the contingent royalty liability relating to VIMOVO.

 

(13) During the six months ended June 30, 2014, the Company recorded non-cash charges of $214,995 related to the increase in the fair value of the embedded derivative associated with its convertible senior notes. The loss on the derivative revaluation was primarily due to an increase in the market value of the Company’s common stock. The loss on derivative revaluation was a permanent tax difference and was not deductible for income tax reporting purposes. On June 27, 2014, the derivative liability was re-measured to a final fair value and the entire fair value of the derivative liability of $324,405 was reclassified to additional paid-in capital. As such, there was no derivative revaluation subsequent to June 2014.

 

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