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8-K - 8-K - Horizon Therapeutics Public Ltd Cod237265d8k.htm

Exhibit 99.1

 

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Horizon Pharma plc Announces Second-Quarter 2016 Financial Results

— Second-Quarter 2016 Record Net Sales of $257.4 Million, Up 49 Percent —

— Second-Quarter 2016 GAAP Net Income of $15.0 Million; Adjusted EBITDA of $121.1 Million —

— Confirms Full-Year 2016 Net Sales Guidance of $1.025 to $1.050 Billion and Full-Year 2016 Adjusted EBITDA Guidance of $495 to $510 Million —

DUBLIN, IRELAND – August 8, 2016 – 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 second-quarter 2016 financial results today and confirmed its full-year 2016 net sales and adjusted EBITDA guidance.

“We exceeded our expectations for the second quarter with another quarter of record net sales and remain on track to meet our objectives for the full year,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. “We continued to execute across all levels of the organization, generating new patient and prescription growth and advancing our pipeline of orphan medicines, including the completion of enrollment in our Phase 3 clinical trial for ACTIMMUNE in Friedreich’s ataxia and the submission of our supplemental new drug application for RAVICTI.”

Financial Highlights

 

(in millions except for per share amounts and percentages)    Q2 16      Q2 15      %
Change
    YTD 16     YTD 15      %
Change
 

Net sales

   $ 257.4       $ 172.8         49      $ 462.1      $ 286.0         62   

Net income (loss)

     15.0         31.8         (53     (30.4     12.3         NM   

Non-GAAP net income (1)

     101.1         61.9         63        156.5        86.4         81   

Adjusted EBITDA

     121.1         76.1         59        193.1        108.5         78   

Earnings (loss) per share - diluted

     0.09         0.20         (55     (0.19     0.08         NM   

Non-GAAP earnings per share - diluted (1)

     0.62         0.39         59        0.96        0.60         60   

 

(1) Horizon Pharma is modifying the method of calculating its non-GAAP income tax expense to align with guidance issued by the U.S. Securities and Exchange Commission (SEC) on May 17, 2016. The table above reflects the Company’s prior method of calculating its non-GAAP income tax expense. Please see the income tax rate discussion in the section titled, “Second-Quarter 2016 Financial Results,” to understand the Company’s new method of calculating its non-GAAP income tax expense as well as a comparison of its non-GAAP tax rate, non-GAAP net income and non-GAAP diluted earnings per share under the new and prior methodologies for 2015 and 2016. This modification has no impact on the amount of cash taxes paid, the Company’s operating cash flows or its full-year 2016 guidance.

 

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Company Highlights

 

    Second-quarter 2016 year-over-year sales growth of 49 percent was driven by strong execution across each of the Company’s business units: Orphan, Rheumatology and Primary Care. Medicines for rare diseases, which include RAVICTI®, ACTIMMUNE®, KRYSTEXXA® and BUPHENYL®, represented 36 percent of total net sales in the second quarter of 2016, an increase from 28 percent of total net sales in the second quarter of 2015.

 

    Second-quarter 2016 net income was $15.0 million. Second-quarter 2016 adjusted EBITDA was $121.1 million.

 

    On August 2, 2016, the Company announced it had secured covered status for DUEXIS® and VIMOVO® with CVS/Caremark. The Company was informed that beginning January 1, 2017, DUEXIS and VIMOVO will be removed from the CVS/Caremark exclusion list. In addition, Horizon continues discussions and negotiations with other pharmacy benefit managers and payers with the goal of further increasing patient access to its clinically relevant primary care medicines in 2017.

 

    On June 29, 2016, the Company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for RAVICTI to expand its age range of use for chronic management of urea cycle disorders (UCDs) in adult and pediatric patients from two years of age and older to two months of age and older.

 

    On May 18, 2016, the Company entered into an agreement to acquire the worldwide rights to interferon gamma-1b, known as ACTIMMUNE in the United States, and expects to close the transaction by year-end 2016, subject to the satisfaction of closing conditions.

Second-Quarter Business Unit Net Sales Results

 

(in millions except for percentages)    Q2 16      Q2 15      %
Change
    YTD 16      YTD 15      %
Change
 

Orphan

   $ 73.5       $ 48.7         51      $ 139.8       $ 73.5         90   

RAVICTI® (1)

     39.4         19.0         107        76.4         19.0         302   

ACTIMMUNE®

     30.0         25.8         16        55.6         50.6         10   

BUPHENYL® (1)

     4.1         3.9         5        7.8         3.9         102   

Rheumatology

     33.2         10.7         211        60.6         18.9         220   

KRYSTEXXA® (2)

     19.9         —           NM        36.0         —           NM   

RAYOS®

     12.1         10.3         18        22.7         17.5         29   

LODOTRA®

     1.2         0.4         218        1.9         1.4         34   

Primary Care

     150.7         113.4         33        261.7         193.5         35   

PENNSAID® 2%

     72.7         29.4         147        127.6         47.7         168   

DUEXIS®

     45.5         44.2         3        75.2         73.1         3   

VIMOVO®

     31.4         39.8         (21     56.9         72.8         (22

MIGERGOT® (2)

     1.1         —           NM        2.0         —           NM   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total net sales

   $ 257.4       $ 172.8         49      $ 462.1       $ 286.0         62   

 

(1) RAVICTI and BUPHENYL were acquired on May 7, 2015.
(2) KRYSTEXXA and MIGERGOT were acquired on January 13, 2016.

 

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    Orphan Business Unit: The orphan commercial organization continues to add new patients to treatment with RAVICTI and ACTIMMUNE. RAVICTI sales in the second quarter of 2016 were $39.4 million, an increase of 107 percent compared to the second quarter of 2015 and 6 percent sequentially compared to the first quarter of 2016. ACTIMMUNE sales in the second quarter of 2016 were $30.0 million, an increase of 16 percent compared to the second quarter of 2015 and 18 percent sequentially compared to the first quarter of 2016.

Regarding its clinical development pipeline for orphan diseases, the Company submitted a sNDA to the U.S. FDA for RAVICTI to expand its age range for chronic management of UCDs from two years of age and older to two months of age and older. If approved, physicians could use RAVICTI instead of BUPHENYL in patients two months to two years of age. The Company completed enrollment in the Safety, Tolerability and Efficacy of ACTIMMUNE Dose Escalation in FA (STEADFAST) Phase 3 clinical trial for ACTIMMUNE on May 5, 2016. With an estimated 3,700 patients in the United States with FA, the Company believes an indication for ACTIMMUNE in FA, if approved, could represent a $500 million to $1 billion peak annual net sales opportunity. In the Phase 1 dosing trial evaluating ACTIMMUNE as a combination therapy for certain cancers, the first six-patient cohort was completed in May and the second six-patient cohort is now enrolling.

On May 18, 2016, the Company entered into an agreement to acquire the worldwide rights to interferon gamma-1b, known as ACTIMMUNE in the United States. The transaction is expected to close by year-end 2016. Horizon Pharma currently owns the rights to interferon gamma-1b in the United States, Canada and Japan and the acquisition will expand rights worldwide. Interferon gamma-1b is currently sold in an estimated 30 countries outside the U.S. Obtaining worldwide rights for interferon gamma-1b will solidify continued investment in the medicine, and pending the outcome of clinical studies investigating it in FA and advanced solid tumors such as kidney and bladder cancer, strengthens the Company’s ability to expand its potential global use.

 

    Rheumatology Business Unit: KRYSTEXXA sales in the second quarter of 2016 were $19.9 million, following the expansion of its commercial organization after the acquisition of Crealta in January 2016. The Company is continuing to capitalize on this expansion effort as well as invest in education and outreach with practicing physicians to share the robust safety and efficacy data from the KRYSTEXXA pivotal trials. RAYOS sales in the second quarter of 2016 were $12.1 million, an increase of 18 percent compared to the second quarter of 2015.

The Company has submitted several abstracts of KRYSTEXXA Phase 3 trial data analyses to the American College of Rheumatology (ACR) annual meeting in November. In addition, data from the Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect (TRIPLE) trial will also be submitted to the ACR meeting. The TRIPLE trial is evaluating safety and efficacy related to KRYSTEXXA immunogenicity.

 

    Primary Care Business Unit: PENNSAID 2% sales in the second quarter of 2016 were $72.7 million, an increase of 147 percent compared to the second quarter of 2015. DUEXIS and VIMOVO sales in the second quarter of 2016 were $45.5 million and $31.4 million, respectively. Total prescriptions for the primary care business unit increased approximately 22 percent compared to the second quarter of 2015, driven primarily by strong performance of PENNSAID 2%.

 

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Second-Quarter 2016 Financial Results

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

 

    Gross Profit: Under U.S. generally accepted accounting principles (GAAP) in the second quarter of 2016, the gross profit ratio was 68.5 percent compared to 64.2 percent in the second quarter of 2015. The non-GAAP gross profit ratio in the second quarter of 2016 was 92.0 percent compared to 91.1 percent in the second quarter of 2015.

 

    Operating Expenses: On a GAAP basis in the second quarter of 2016, total operating expenses were 56.3 percent of sales. Research & development (R&D) expenses were 4.4 percent of sales, sales & marketing (S&M) expenses were 30.9 percent of sales and general & administrative (G&A) expenses were 21.0 percent of sales. Non-GAAP total operating expenses in the second quarter of 2016 were 44.9 percent of sales. Non-GAAP R&D expenses were 3.3 percent of sales, non-GAAP S&M expenses were 28.1 percent of sales and non-GAAP G&A expenses were 13.5 percent of sales.

 

    Income Tax Rate: Horizon Pharma is modifying the method of calculating its non-GAAP income tax expense to align with guidance issued by the SEC on May 17, 2016. The new methodology, which the Company will begin using exclusively in the third quarter, calculates the income tax component of non-GAAP net income for each period by adjusting the GAAP income tax expense (benefit) for the estimated tax impact of each non-GAAP adjustment based on the statutory tax rate of the applicable jurisdiction for each non-GAAP adjustment. This new methodology does not reflect any use of net operating loss carryforwards that the Company potentially may have been able to use if its actual earnings for these periods had been the non-GAAP net income. Importantly, this change has no impact on the amount of cash taxes paid, operating cash flows or full-year guidance for net sales or adjusted EBITDA. Previously, the Company had calculated the income tax component of non-GAAP net income by using the estimated cash taxes that it expected to pay for the period. The tables below provide the GAAP to non-GAAP income tax rate reconciliation using both the new and prior methodology along with the resulting non-GAAP net income and non-GAAP diluted earnings per share under each method. A full reconciliation for the first and second quarters of 2016 and all of 2015 are at the end of this release and posted to the investor relations section of the Horizon Pharma website.

 

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GAAP to Non-GAAP Tax Rate Reconciliation (Unaudited) for Q2 2016, Q2 2015 and

Year-to-Date 2016 and 2015

 

     Q2 2016  
     Pre-tax Net
Income
    Income Tax
Expense (Benefit)
    Tax Rate     Net Income     Diluted Earnings
Per Share
 

As reported - GAAP

   $ 12.2      $ (2.8     (22.5 )%    $ 15.0      $ 0.09   

Non-GAAP adjustments

     94.3        18.0          76.3     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP - new methodology

   $ 106.5      $ 15.2        14.4   $ 91.3      $ 0.56   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported - GAAP

   $ 12.2      $ (2.8     (22.5 )%    $ 15.0      $ 0.09   

Non-GAAP adjustments

     94.3        8.2          86.1     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP - prior methodology

   $ 106.5      $ 5.4        5.1   $ 101.1      $ 0.62   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
     Q2 2015  
     Pre-tax Net
Income (Loss)
    Income Tax
Expense (Benefit)
    Tax Rate     Net Income
(Loss)
    Diluted Earnings
Per Share
 

As reported - GAAP

   $ (128.9   $ (160.7     124.7   $ 31.8      $ 0.20   

Non-GAAP adjustments

     191.2        59.0          132.2     

Other Non-GAAP tax adjustment

     —          105.1          (105.1  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP - new methodology

   $ 62.3      $ 3.4        5.6   $ 58.9      $ 0.37   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported - GAAP

   $ (128.9   $ (160.7     124.7   $ 31.8      $ 0.20   

Non-GAAP adjustments

     191.2        56.0          135.2     

Other Non-GAAP tax adjustment

     —          105.1          (105.1  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP - prior methodology

   $ 62.3      $ 0.4        0.7   $ 61.9      $ 0.39   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
     Q2 2016 YTD  
     Pre-tax Net
Income (Loss)
    Income Tax
Expense (Benefit)
    Tax Rate     Net Income
(Loss)
    Diluted Earnings
(Loss) Per Share
 

As reported - GAAP

   $ (34.6   $ (4.2     12.1   $ (30.4   $ (0.19

Non-GAAP adjustments

     198.3        35.3          163.0     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP - new methodology

   $ 163.7      $ 31.1        19.0   $ 132.6      $ 0.81   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported - GAAP

   $ (34.6   $ (4.2     12.1   $ (30.4   $ (0.19

Non-GAAP adjustments

     198.3        11.4          186.9     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP - prior methodology

   $ 163.7      $ 7.2        4.4   $ 156.5      $ 0.96   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
     Q2 2015 YTD  
     Pre-tax Net
Income (Loss)
    Income Tax
Expense (Benefit)
    Tax Rate     Net Income
(Loss)
    Diluted Earnings
Per Share
 

As reported - GAAP

   $ (146.5   $ (158.8     108.4   $ 12.3      $ 0.08   

Non-GAAP adjustments

     233.6        59.2          174.4     

Other Non-GAAP tax adjustment

     —          105.1          (105.1  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP - new methodology

   $ 87.1      $ 5.5        6.4   $ 81.6      $ 0.56   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported - GAAP

   $ (146.5   $ (158.8     108.4   $ 12.3      $ 0.08   

Non-GAAP adjustments

     233.6        54.4          179.2     

Other Non-GAAP tax adjustment

     —          105.1          (105.1  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP - prior methodology

   $ 87.1      $ 0.7        0.8   $ 86.4      $ 0.60   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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On a GAAP basis in the second quarter of 2016, the tax rate was (22.5) percent and the non-GAAP tax rate using the new method for calculating non-GAAP income taxes was 14.4 percent. For comparison purposes only during this transition period, under the prior methodology, the cash tax rate was 5.1 percent, which was in line with the Company’s previous full-year cash tax rate guidance of low single digits.

 

    Net Income: On a GAAP basis in the second quarter of 2016, net income was $15.0 million and non-GAAP net income using the tax rate of 14.4 percent was $91.3 million. For comparison purposes only during this transition period, non-GAAP net income using the cash tax rate of 5.1 percent was $101.1 million. On a GAAP basis in the second quarter of 2015, net income was $31.8 million and non-GAAP net income using the non-GAAP tax rate of 5.6 percent was $58.9 million. For comparison purposes only during this transition period, non-GAAP net income using the cash tax rate of 0.7 percent was $61.9 million.  (Please refer to tax rate reconciliation tables in this release and on the Horizon Pharma website).

 

    EBITDA: On an unadjusted basis in the second quarter of 2016, EBITDA was $101.9 million, or 39.6 percent of sales. Adjusted EBITDA in the second quarter of 2016 was $121.1 million, or 47.0 percent of sales, compared to $76.1 million, or 44.0 percent of sales in the second quarter of 2015.

 

    Earnings per Share: On a GAAP basis in the second quarter of 2016, diluted earnings per share was $0.09 and non-GAAP diluted earnings per share using the non-GAAP tax rate of 14.4 percent was $0.56. For comparison purposes only during this transition period, non-GAAP diluted earnings per share using the cash tax rate of 5.1 percent was $0.62. Weighted average shares outstanding used for calculating diluted earnings per share in the second quarter of 2016 were 163.9 million. On a GAAP basis in the second quarter of 2015, diluted earnings per share was $0.20 and non-GAAP diluted earnings per share using the non-GAAP tax rate of 5.6 percent was $0.37. For comparison purposes only during this transition period, non-GAAP diluted earnings per share using the cash tax rate of 0.7 percent was $0.39 as previously reported.  (Please refer to tax rate reconciliation tables in this release and on the Horizon Pharma website).

Cash Flow Statement and Balance Sheet Highlights

 

    On a GAAP basis in the second quarter of 2016, operating cash flow was $47.3 million. Non-GAAP operating cash flow was $58.2 million in the second quarter of 2016. On a GAAP basis, the first half of 2016 operating cash flow was $101.5 million compared to the first half of 2015 operating cash flow of ($29.2) million. On a non-GAAP basis, the first half of 2016 operating cash flow was $126.1 million compared to the first half of 2015 operating cash flow of $66.4 million.

 

    The Company had cash and cash equivalents of $424.5 million as of June 30, 2016.

 

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    Total principal amount of debt outstanding was $1.271 billion as of June 30, 2016, which was composed of $396 million in senior secured term loans due 2021, $475 million in 6.625 percent senior notes due 2023 and $400 million of 2.5 percent exchangeable senior notes due 2022. Net debt in the second quarter was $846.5 million.

 

    As of June 30, 2016, the Company had a total debt to last 12 months (LTM) adjusted EBITDA leverage ratio of 2.8 and a net debt to LTM adjusted EBITDA leverage ratio of 1.9.

Conference Call

At 8 a.m. EDT / 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: 43465144

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: 43465144

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 nine medicines through its orphan, rheumatology and primary care business units. 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 non-GAAP net income, non-GAAP earnings per share, non-GAAP gross profit and gross profit ratio, non-GAAP operating and other expenses, non-GAAP cash from operations and non-GAAP income tax information, each of which include adjustments to GAAP figures. Adjusted EBITDA, non-GAAP net income and non-GAAP cash from operations are intended to provide additional information on Horizon’s performance, operations, profitability and cash flows. Adjustments to Horizon’s GAAP figures as well as

 

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EBITDA exclude acquisition-related expenses, an upfront fee for a license of a patent, loss on debt extinguishment and loss on sale of long-term investments, 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 maintains an established non-GAAP cost policy that guides the determination of what costs will be excluded in non-GAAP measures. Horizon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon’s financial and operating 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 2016 financial results and trends and to facilitate comparisons between periods and with respect to projected information. 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. For example, adjusted EBITDA is used by Horizon as one measure of management performance under certain incentive compensation arrangements. 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 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 reconciliations of its full-year 2016 adjusted EBITDA or non-GAAP income tax outlook to an expected net income (loss) or GAAP income tax expense outlook because certain items such as acquisition-related expenses and share-based compensation that are a component of net income (loss) and impact GAAP income taxes expenses, cannot be reasonably projected due to the significant impact of changes in Horizon’s stock price, the variability associated with the size or timing of acquisitions, and other factors. These components of net income (loss) could significantly impact Horizon’s actual net income (loss) and income tax expense.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to Horizon Pharma’s expected full-year 2016 net sales and adjusted EBITDA guidance and second-half and full-year 2016 non-GAAP tax rates, expected financial performance in future periods, expected timing of clinical, regulatory and commercial events, Horizon Pharma’s plans to continue discussions with PBMs and payers to expand access to its primary care medicines and the potential outcome of those discussions, the expectation that DUEXIS and VIMOVO will be removed from the CVS/Caremark exclusion list and the timing thereof, expected timing and potential benefits of acquiring the worldwide rights to interferon gamma-1b, potential market opportunity for ACTIMMUNE in FA, potential growth of Horizon Pharma’s business and other statements that are not historical facts. These forward-looking statements are based on Horizon Pharma’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 2016 financial and operating results and non-GAAP tax rates 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 payers and risks relating to the success and costs of Horizon’s patient support program; whether Horizon Pharma is unable to enter into additional business arrangements with pharmacy benefit managers and payers on favorable terms or at all; whether CVS/Caremark makes other changes to its exclusion list or that DUEXIS or VIMOVO are later re-included in the CVS/Caremark exclusion list; risks associated with clinical development and regulatory approvals; risks in the ability to recruit, train and retain qualified personnel; competition, including potential generic competition; the ability to satisfy closing conditions related to Horizon Pharma’s acquisition of the worldwide rights to interferon

 

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gamma-1b; 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 Pharma’s filings and reports with the SEC. Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information.

 

Contacts:   
Investors:    U.S. Media:
John Thomas    Geoff Curtis
Executive Vice President, Strategy & Investor Relations    Senior Vice President, Corporate Communications
investor-relations@horizonpharma.com    gcurtis@horizonpharma.com
Tina Ventura    Ireland Media:
Vice President, Investor Relations    Ray Gordon
investor-relations@horizonpharma.com    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 June 30,     Six Months Ended June 30,  
     2016     2015     2016     2015  

Net sales

   $ 257,378      $ 172,821      $ 462,068      $ 285,962   

Cost of goods sold

     81,126        61,826        158,359        90,679   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     176,252        110,995        303,709        195,283   
  

 

 

   

 

 

   

 

 

   

 

 

 

OPERATING EXPENSES:

        

Research and development

     11,210        8,922        23,932        15,103   

Sales and marketing

     79,589        58,056        155,133        105,119   

General and administrative

     53,986        77,190        120,381        103,470   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     144,785        144,168        299,446        223,692   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss)

     31,467        (33,173     4,263        (28,409
  

 

 

   

 

 

   

 

 

   

 

 

 

OTHER EXPENSE, NET:

        

Interest expense, net

     (19,228     (19,448     (38,686     (29,480

Foreign exchange gain (loss)

     15        (87     (158     (924

Loss on induced conversion of debt and debt extinguishment

     —          (67,080     —          (77,624

Other expense, net

     (26     (9,078     (40     (10,069
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense, net

     (19,239     (95,693     (38,884     (118,097
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before benefit for income taxes

     12,228        (128,866     (34,621     (146,506

BENEFIT FOR INCOME TAXES

     (2,756     (160,680     (4,199     (158,767
  

 

 

   

 

 

   

 

 

   

 

 

 

NET INCOME (LOSS)

   $ 14,984      $ 31,814      $ (30,422   $ 12,261   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per ordinary share - basic

   $ 0.09      $ 0.21      $ (0.19   $ 0.09   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average ordinary shares outstanding - basic

     160,468,146        150,771,902        160,186,270        138,369,537   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per ordinary share - diluted

   $ 0.09      $ 0.20      $ (0.19   $ 0.08   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average ordinary shares outstanding - diluted

     163,920,581        159,797,319        160,186,270        145,031,882   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

10


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Horizon Pharma plc

Consolidated Balance Sheets (Unaudited)

(in thousands, except share data)

 

     As of  
     June 30,
2016
    December 31,
2015
 

ASSETS

    

CURRENT ASSETS:

    

Cash and cash equivalents

   $ 424,525      $ 859,616   

Restricted cash

     3,169        1,860   

Accounts receivable, net

     304,382        210,437   

Inventories, net

     172,102        18,376   

Prepaid expenses and other current assets

     33,866        15,858   
  

 

 

   

 

 

 

Total current assets

     938,044        1,106,147   
  

 

 

   

 

 

 

Property and equipment, net

     21,971        14,020   

Developed technology, net

     1,927,713        1,609,049   

In-process research and development

     66,000        66,000   

Other intangible assets, net

     6,655        7,061   

Goodwill

     255,927        253,811   

Deferred tax assets, net

     4,992        2,278   

Other assets

     6,156        222   
  

 

 

   

 

 

 

TOTAL ASSETS

   $ 3,227,458      $ 3,058,588   
  

 

 

   

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

    

CURRENT LIABILITIES:

    

Long-term debt - current portion

   $ 4,000      $ 4,000   

Accounts payable

     58,970        16,590   

Accrued expenses

     75,709        100,046   

Accrued trade discounts and rebates

     220,674        183,769   

Accrued royalties - current portion

     58,008        51,700   

Deferred revenues - current portion

     1,448        1,447   
  

 

 

   

 

 

 

Total current liabilities

     418,809        357,552   
  

 

 

   

 

 

 

LONG-TERM LIABILITIES:

    

Exchangeable notes, net

     290,310        282,889   

Long-term debt, net, net of current

     849,377        849,867   

Accrued royalties, net of current

     170,160        123,519   

Deferred revenues, net of current

     8,366        8,785   

Deferred tax liabilities, net

     131,587        113,400   

Other long-term liabilities

     20,636        9,431   
  

 

 

   

 

 

 

Total long-term liabilities

     1,470,436        1,387,891   
  

 

 

   

 

 

 

COMMITMENTS AND CONTINGENCIES

    

SHAREHOLDERS’ EQUITY:

    

Ordinary shares, $0.0001 nominal value; 300,000,000 shares authorized; 161,126,363 and 160,069,067 issued at June 30, 2016 and December 31, 2015, respectively, and 160,741,997 and 159,684,701 outstanding at June 30, 2016 and December 31, 2015, respectively.

     16        16   

Treasury stock, 384,366 ordinary shares at June 30, 2016 and December 31, 2015

     (4,585     (4,585

Additional paid-in capital

     2,057,128        2,001,552   

Accumulated other comprehensive loss

     (2,737     (2,651

Accumulated deficit

     (711,609     (681,187
  

 

 

   

 

 

 

Total shareholders’ equity

     1,338,213        1,313,145   
  

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

   $ 3,227,458      $ 3,058,588   
  

 

 

   

 

 

 

 

11


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Horizon Pharma plc

Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2016     2015     2016     2015  
     (Unaudited)     (Unaudited)  

CASH FLOWS FROM OPERATING ACTIVITIES:

        

Net income (loss)

   $ 14,984      $ 31,814      $ (30,422   $ 12,261   

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

        

Depreciation and amortization expense

     51,883        32,408        102,525        50,743   

Equity-settled share-based compensation

     27,673        24,665        55,418        31,339   

Royalty accretion

     9,669        3,977        19,028        7,021   

Royalty liability remeasurement

     —          14,277        —          14,277   

Loss on induced conversions of debt and debt extinguishment

     —          16,733        —          21,581   

Amortization of debt discount and deferred financing costs

     4,507        5,622        8,932        7,828   

Foreign exchange (gain) loss and other adjustments

     (14     84        159        1,023   

Changes in operating assets and liabilities:

        

Accounts receivable

     (14,094     (43,724     (83,932     (97,167

Inventories

     6,460        7,467        13,777        10,555   

Prepaid expenses and other current assets

     (16,384     38,904        (16,626     4,597   

Accounts payable

     (10,578     1,622        42,278        1,604   

Accrued trade discounts and rebates

     (5,121     45,408        35,480        47,596   

Accrued expenses and accrued royalties

     (20,006     22,514        (43,527     16,492   

Deferred revenues

     80        2,804        (418     2,778   

Deferred income taxes

     (2,705     (160,229     (5,362     (158,873

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

     —          (3,000     —          (3,000

Other non-current assets and liabilities

     949        238        4,174        190   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     47,303        41,584        101,484        (29,155
  

 

 

   

 

 

   

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

        

Payments for acquisitions, net of cash acquired

     (5,591     (1,022,361     (520,405     (1,022,361

Proceeds from liquidation of available-for-sale investments

     —          64,623        —          64,623   

Change in restricted cash

     (391     —          (1,309     138   

Purchases of property and equipment

     (5,251     (704     (12,776     (2,281
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (11,233     (958,442     (534,490     (959,881
  

 

 

   

 

 

   

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

        

Net proceeds from the issuance of Exchangable Senior Notes

     —          (819     —          387,181   

Net proceeds from the issuance of 2023 Senior Notes

     —          462,340        —          462,340   

Net proceeds from the 2015 Term Loan Facility

     —          391,719        —          391,719   

Repayment of the 2015 Term Loan Facility

     (1,000     —          (2,000     —     

Repayment of the 2014 Term Loan Facility

     —          (297,000     —          (297,000

Net proceeds from the issuance of ordinary shares

     —          475,627        —          475,627   

Proceeds from the issuance of ordinary shares in connection with warrant exercises

     —          4,769        —          14,693   

Proceeds from the issuance of ordinary shares through ESPP programs

     3,235        1,541        3,235        1,541   

Proceeds from the issuance of ordinary shares in connection with stock option exercises

     739        2,099        1,658        3,888   

Payment of employee withholding taxes relating to share-based awards

     (549     (741     (4,734     (1,956
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) financing activities

     2,425        1,039,535        (1,841     1,438,033   
  

 

 

   

 

 

   

 

 

   

 

 

 

Effect of foreign exchange rate changes on cash and cash equivalents

     177        169        (244     (747
  

 

 

   

 

 

   

 

 

   

 

 

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

     38,672        122,846        (435,091     448,250   

CASH AND CASH EQUIVALENTS, beginning of the period

     385,853        544,211        859,616        218,807   
  

 

 

   

 

 

   

 

 

   

 

 

 

CASH AND CASH EQUIVALENTS, end of the period

   $ 424,525      $ 667,057      $ 424,525      $ 667,057   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

12


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Horizon Pharma plc

GAAP to Non-GAAP Reconciliations

Net Income and Earnings Per Share - Prior Methodology (Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2016     2015     2016     2015  

GAAP Net Income (Loss)

   $ 14,984      $ 31,814      $ (30,422 )    $ 12,261   

Non-GAAP Adjustments:

        

Remeasurement of royalties for medicines acquired through business combinations

     —          14,277        —          14,277   

Acquisition-related costs

     281        46,689        11,297        50,343   

Upfront fee for license of global patent

     —          —          2,000        —     

Loss on induced conversion of debt and debt extinguishment

     —          67,080        —          77,624   

Amortization and accretion:

        

Intangible amortization expense

     50,792        31,832        100,442        49,510   

Amortization of debt discount and deferred financing costs

     4,507        5,622        8,932        7,848   

Accretion of royalty liabilities

     9,669        3,977        19,028        7,020   

Amortizaton of inventory step-up adjustment

     9,102        3,341        16,548        6,495   

Share-based compensation

     27,997        24,665        55,609        31,339   

Depreciation expense

     1,091        576        2,083        1,230   

Royalties for medicines acquired through business combinations (1)

     (9,095     (6,840     (17,595     (12,036
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of pre-tax non-GAAP adjustments

     94,344        191,219        198,344        233,650   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income tax adjustments - prior methodology

     (8,213     (56,002     (11,365     (54,373

Other non-GAAP income tax adjustments

     —          (105,133     —          (105,133
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     86,131        30,084        186,979        74,144   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Net Income - Prior Methodology

   $ 101,115      $ 61,898      $ 156,557      $ 86,405   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Earnings Per Share:

        

Weighted average shares - Basic

     160,468,146        150,771,902        160,186,270        138,369,537   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP earnings per share - Basic

        

GAAP loss per share - Basic

   $ 0.09      $ 0.21      $ (0.19 )    $ 0.09   

Non-GAAP adjustments

     0.54        0.20        1.17        0.53   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP earnings per share - Basic - Prior Methodology

   $ 0.63      $ 0.41      $ 0.98      $ 0.62   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares - Diluted

        

Weighted average shares - Basic

     160,468,146        150,771,902        160,186,270        138,369,537   

Ordinary share equivalents

     3,452,435        9,025,417        3,630,429        6,662,345   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares - Diluted

     163,920,581        159,797,319        163,816,699        145,031,882   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP earnings per share - Diluted

        

GAAP loss per share - Diluted

   $ 0.09      $ 0.20      $ (0.19 )    $ 0.08   

Non-GAAP adjustments

     0.53        0.19        1.17        0.52   

Diluted earnings per share effect of ordinary share equivalents

     —          —          (0.02     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP earnings per share - Diluted - Prior Methodology

   $ 0.62      $ 0.39      $ 0.96      $ 0.60   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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

 

 

13


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Horizon Pharma plc

GAAP to Non-GAAP Reconciliations

Net Income and Earnings Per Share — New Methodology (Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2016     2015     2016     2015  

GAAP Net Income (Loss)

   $ 14,984      $ 31,814      $ (30,422   $ 12,261   

Non-GAAP Adjustments:

        

Remeasurement of royalties for medicines acquired through business combinations

     —          14,277        —          14,277   

Acquisition-related costs

     281        46,689        11,297        50,343   

Upfront fee for license of global patent

     —          —          2,000        —     

Loss on induced conversion of debt and debt extinguishment

     —          67,080        —          77,624   

Amortization and accretion:

        

Intangible amortization expense

     50,792        31,832        100,442        49,510   

Amortization of debt discount and deferred financing costs

     4,507        5,622        8,932        7,848   

Accretion of royalty liabilities

     9,669        3,977        19,028        7,020   

Amortizaton of inventory step-up adjustment

     9,102        3,341        16,548        6,495   

Share-based compensation

     27,997        24,665        55,609        31,339   

Depreciation expense

     1,091        576        2,083        1,230   

Royalties for medicines acquired through business combinations (1)

     (9,095     (6,840     (17,595     (12,036
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of pre-tax non-GAAP adjustments

     94,344        191,219        198,344        233,650   

Income tax effect of pre-tax non-GAAP adjustments

     (18,064     (59,028     (35,338     (59,200

Other non-GAAP income tax adjustments

     —          (105,133     —          (105,133
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     76,280        27,058        163,006        69,317   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Net Income

   $ 91,264      $ 58,872      $ 132,584      $ 81,578   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Earnings Per Share:

        

Weighted average shares - Basic

     160,468,146        150,771,902        160,186,270        138,369,537   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Earnings Per Share - Basic:

        

GAAP earnings (loss) per share - Basic

   $ 0.09      $ 0.21      $ (0.19   $ 0.09   

Non-GAAP adjustments

     0.48        0.18        1.02        0.50   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP earnings per share - Basic

   $ 0.57      $ 0.39      $ 0.83      $ 0.59   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares - Diluted

        

Weighted average shares - Basic

     160,468,146        150,771,902        160,186,270        138,369,537   

Ordinary share equivalents

     3,452,435        9,025,417        3,630,429        6,662,345   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares - Diluted

     163,920,581        159,797,319        163,816,699        145,031,882   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Earnings Per Share - Diluted

        

GAAP earnings (loss) per share - Diluted

   $ 0.09      $ 0.20      $ (0.19   $ 0.08   

Non-GAAP adjustments

     0.47        0.17        1.02        0.48   

Diluted earnings per share effect of ordinary share equivalents

     —          —          (0.02     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP earnings per share - Diluted

   $ 0.56      $ 0.37      $ 0.81      $ 0.56   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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

 

14


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Horizon Pharma plc

GAAP to Non-GAAP Reconciliations

EBITDA, Gross Profit and Operating Cash Flow (Unaudited)

(in thousands, except percentages)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2016     2015     2016     2015  

EBITDA and Non-GAAP EBITDA:

        

GAAP Net Income (Loss)

   $ 14,984      $ 31,814      $ (30,422   $ 12,261   

Depreciation

     1,091        576        2,083        1,230   

Amortization and accretion:

        

Intangible amortization expense

     50,792        31,832        100,442        49,510   

Accretion of royalty liabilities

     9,669        3,977        19,028        7,020   

Amortization of deferred revenue

     (213     (129     (419     (263

Amortizaton of inventory step-up adjustment

     9,102        3,341        16,548        6,495   

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

     19,228        19,448        38,686        29,480   

Benefit for income taxes

     (2,756     (160,680     (4,199     (158,767
  

 

 

   

 

 

   

 

 

   

 

 

 

EBITDA

   $ 101,897      $ (69,821   $ 141,747      $ (53,034
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP adjustments:

        

Remeasurement of royalties for medicines acquired through business combinations

     —          14,277        —          14,277   

Acquisition-related costs

     281        46,689        11,297        50,343   

Upfront fee for license of global patent

     —          —          2,000        —     

Loss on induced conversion of debt and debt extinguishment

     —          67,080        —          77,624   

Share-based compensation

     27,997        24,665        55,609        31,339   

Royalties for medicines acquired through business combinations (1)

     (9,095     (6,840     (17,595     (12,036
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of Non-GAAP adjustments

     19,183        145,871        51,311        161,547   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 121,080      $ 76,050      $ 193,058      $ 108,513   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Gross Profit:

        

GAAP gross profit

   $ 176,252      $ 110,995      $ 303,709      $ 195,283   

Non-GAAP gross profit adjustments:

        

Acquisition-related costs

     296        —          411        —     

Remeasurement of royalties for medicines acquired through business combinations

     —          14,277        —          14,277   

Intangible amortization expense (COGS only)

     50,590        31,628        100,037        49,105   

Accretion of royalty liabilities

     9,669        3,977        19,028        7,020   

Amortizaton of inventory step-up adjustment

     9,102        3,341        16,548        6,495   

Depreciation (COGS only)

     100        74        220        203   

Royalties for medicines acquired through business combinations (1)

     (9,095     (6,840     (17,595     (12,036
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of Non-GAAP adjustments

     60,662        46,457        118,649        65,064   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP gross profit

   $ 236,914      $ 157,452      $ 422,358      $ 260,347   
  

 

 

   

 

 

   

 

 

   

 

 

 

GAAP gross profit %

     68.5     64.2     65.7     68.3

Non-GAAP gross profit %

     92.0     91.1     91.4     91.0

Non-GAAP operating cash flow:

        

GAAP cash provided by (used in) operating activities

   $ 47,303      $ 41,584      $ 101,484      $ (29,155

Cash payments for acquisition-related costs

     10,883        34,868        22,577        36,688   

Cash payments for upfront fee for license of global patent

     —          —          2,000        —     

Cash payments for induced debt conversion

     —          4,776        —          10,472   

Cash payment for debt extinguishment

     —          45,367        —          45,367   

Payment of original issue discount on debt extinguishment

     —          3,000        —          3,000   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP operating cash flow

   $ 58,186      $ 129,595      $ 126,061      $ 66,372   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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

 

 

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Horizon Pharma plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Three Months Ended June 30, 2016

(Unaudited)

 

                                   Income Tax  
           Research &     Sales &     General &     Interest     Benefit  
     COGS     Development     Marketing     Administrative     Expense     (Expense)  

GAAP as reported

   $ (81,126   $ (11,210   $ (79,589   $ (53,986   $ (19,228   $ 2,756   

Non-GAAP Adjustments (in thousands):

            

Acquisition-related costs (1)

     297        506        —          (522     —          —     

Upfront fee for license of global patent (2)

     —          —          —          —          —          —     

Amortization and accretion:

            

Intangible amortization expense (3)

     50,589        —          203        —          —          —     

Amortization of debt discount and deferred financing costs (4)

     —          —          —          —          4,507        —     

Accretion of royalty liability (5)

     9,669        —          —          —          —          —     

Amortization of inventory step-up adjustment (6)

     9,102        —          —          —          —          —     

Share-based compensation (7)

     —          2,238        6,932        18,827        —          —     

Depreciation expense (8)

     100        —          15        976        —          —     

Royalties for medicines acquired through business combinations (9)

     (9,095     —          —          —          —          —     

Income tax effect on pre-tax non-GAAP adjustments (10)

     —          —          —          —          —          (18,064
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     60,662        2,744        7,150        19,281        4,507        (18,064
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

   $ (20,464   $ (8,466   $ (72,439   $ (34,705   $ (14,721   $ (15,308
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Horizon Pharma plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Three Months Ended June 30, 2015

(Unaudited)

 

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

GAAP as reported

  $ (61,826   $ (8,922   $ (58,056   $ (77,190   $ (19,448   $ (67,080   $ (9,078   $ 160,680   

Non-GAAP Adjustments (in thousands):

               

Loss on induced conversion of debt and debt extinguishment (11)

    —          —          —          —          —          67,080        —          —     

Acquisition-related costs (1)

    —          —          —          37,689        —          —          9,000        —     

Amortization and accretion:

               

Intangible amortization expense (3)

    31,628        —          204        —          —          —          —          —     

Amortization of debt discount and deferred financing costs (4)

    —          —          —          —          5,622        —          —          —     

Accretion of royalty liability (5)

    3,977        —          —          —          —          —          —          —     

Amortization of inventory step-up adjustment (6)

    3,341        —          —          —          —          —          —          —     

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

    14,277        —          —          —          —          —          —          —     

Share-based compensation (7)

    —          2,212        5,735        16,718        —          —          —          —     

Depreciation expense (8)

    74        —          —          502        —          —          —          —     

Royalties for medicines acquired through business combinations (9)

    (6,840     —          —          —          —          —          —          —     

Income tax effect on pre-tax non-GAAP adjustments (10)

    —          —          —          —          —          —          —          (59,028

Other non-GAAP income tax adjustments (13)

    —          —          —          —          —          —          —          (105,133
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

    46,457        2,212        5,939        54,909        5,622        67,080        9,000        (164,161
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

  $ (15,369   $ (6,710   $ (52,117   $ (22,281   $ (13,826   $ —        $ (78   $ (3,481
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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Horizon Pharma plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Six Months Ended June 30, 2016

(Unaudited)

 

                                  Income Tax  
          Research &     Sales &     General &     Interest     Benefit  
    COGS     Development     Marketing     Administrative     Expense     (Expense)  

GAAP as reported

  $ (158,359   $ (23,932   $ (155,133   $ (120,381   $ (38,686   $ 4,199   

Non-GAAP Adjustments (in thousands):

           

Acquisition-related costs (1)

    411        538        —          10,348        —          —     

Upfront fee for license of global patent (2)

    —          2,000        —          —          —          —     

Amortization and accretion:

           

Intangible amortization expense (3)

    100,037        —          405        —          —          —     

Amortization of debt discount and deferred financing costs (4)

    —          —          —          —          8,932        —     

Accretion of royalty liability (5)

    19,028        —          —          —          —          —     

Amortization of inventory step-up adjustment (6)

    16,548        —          —          —          —          —     

Share-based compensation (7)

    —          4,363        12,610        38,636        —          —     

Depreciation expense (8)

    220        —          26        1,837        —          —     

Royalties for medicines acquired through business combinations (9)

    (17,595     —          —          —          —          —     

Income tax effect on pre-tax non-GAAP adjustments (10)

    —          —          —          —          —          (35,338
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

    118,649        6,901        13,041        50,821        8,932        (35,338
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

  $ (39,710   $ (17,031   $ (142,092   $ (69,560   $ (29,754   $ (31,139
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Horizon Pharma plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Six Months Ended June 30, 2015

(Unaudited)

 

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

GAAP as reported

  $ (90,679   $ (15,103   $ (105,119   $ (103,470   $ (29,480   $ (77,624   $ (10,069   $ 158,767   

Non-GAAP Adjustments (in thousands):

               

Loss on induced conversion of debt and debt extinguishment (11)

    —          —          —          —          —          77,624        —          —     

Acquisition-related costs (1)

    23        94        —          40,226        —          —          10,000        —     

Amortization and accretion:

               

Intangible amortization expense (3)

    49,104        —          406        —          —          —          —          —     

Amortization of debt discount and deferred financing costs (4)

    —          —          —          —          7,848        —          —          —     

Accretion of royalty liability (5)

    7,020        —          —          —          —          —          —          —     

Amortization of inventory step-up adjustment (6)

    6,495        —          —          —          —          —          —          —     

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

    14,277        —          —          —          —          —          —          —     

Share-based compensation (7)

    —          2,670        8,536        20,133        —          —          —          —     

Depreciation expense (8)

    203        —          —          1,027        —          —          —          —     

Royalties for medicines acquired through business combinations (9)

    (12,036     —          —          —          —          —          —          —     

Income tax effect on pre-tax non-GAAP adjustments (10)

    —          —          —          —          —          —          —          (59,200

Other non-GAAP income tax adjustments (13)

    —          —          —          —          —          —          —          (105,133
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

    65,086        2,764        8,942        61,386        7,848        77,624        10,000        (164,333
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

  $ (25,593   $ (12,339   $ (96,177   $ (42,084   $ (21,632   $ —        $ (69   $ (5,566
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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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”), Hyperion Therapeutics, Inc. (“Hyperion”) and Crealta Holdings LLC (“Crealta”), its agreement to acquire the worldwide rights to interferon gamma-1b, and its withdrawn offer to acquire Depomed Inc. have been excluded.
(2) Represents an upfront fee paid for a license of a global patent.
(3) Intangible amortization expenses are associated with the Company’s intellectual property rights, developed technology and customer relationships of VIMOVO, LODOTRA, RAYOS, ACTIMMUNE, PENNSAID 2%, RAVICTI, BUPHENYL, KRYSTEXXA and MIGERGOT.
(4) Represents amortization of debt discount and deferred financing costs associated with the Company’s debt.
(5) Represents accretion expense associated with the ACTIMMUNE, VIMOVO, RAVICTI, BUPHENYL, KRYSTEXXA and MIGERGOT royalties for the three and six months ended June 30, 2016 and represents accretion expense associated with the ACTIMMUNE, VIMOVO, RAVICTI and BUPHENYL royalties for the three and six months ended June 30, 2015.
(6) In connection with the Crealta acquisition, the KRYSTEXXA and MIGERGOT inventory was stepped up in value by $161,901 and during the three months ended June 30, 2016, the Company recognized in cost of goods sold $9,102 of step-up inventory costs related to KRYSTEXXA and MIGERGOT inventory sold. During the six months ended June 30, 2016, the Company recognized in cost of goods sold $16,548 of step-up inventory costs related to KRYSTEXXA and MIGERGOT inventory sold. In connection with the Hyperion acquisition, the RAVICTI and BUPHENYL inventory was stepped up in value by $8,682 and during the second quarter of 2015, the Company recognized in cost of goods sold $3,341 of step-up inventory costs related to RAVICTI and BUPHENYL. In connection with the Vidara acquisition, the ACTIMMUNE inventory was stepped up in value by $14,218 and during the six months ended June 30, 2015, the Company recognized in cost of goods sold $3,154 of step-up inventory costs related to ACTIMMUNE.
(7) 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.
(8) Represents depreciation expense related to the Company’s property, equipment, software and leasehold improvements.
(9) Royalties of $9,095 and $17,595 were incurred during the three and six months ended June 30, 2016, respectively, based on the periods’ net sales for VIMOVO, ACTIMMUNE, RAVICTI, BUPHENYL, KRYSTEXXA and MIGERGOT. Royalties of $6,840 and $12,036 were incurred during the three and six months ended June 30, 2015, respectively, based on the periods’ net sales for VIMOVO, ACTIMMUNE, RAVICTI and BUPHENYL.
(10) Income tax adjustments on pre-tax non-GAAP adjustments represent the estimated income tax impact of each pre-tax non-GAAP adjustment based on the statutory income tax rate of the applicable jurisdictions for each non-GAAP adjustment.
(11) During the three months ended June 30, 2015, the Company recorded a loss on induced debt conversions of $67,080, which represented an early redemption payment of $45,366, the write-down of $16,733 in debt discount and deferred financing costs, $4,635 in additional exchange consideration to debt holders and $346 in expenses incurred in connection with the induced debt conversions. 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.
(12) At the time of the Company’s acquisition of the rights to ACTIMMUNE, BUPHENYL, KRYSTEXXA, MIGERGOT, RAVICTI and VIMOVO, 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 adjustment 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 adjust the amount of the contingent royalty liabilities relating to ACTIMMUNE and VIMOVO.

 

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(13) Other non-GAAP income tax adjustments in the three months ended June 30, 2015 of $105,133 related to the release of certain valuation allowances in connection with the Hyperion acquisition.

 

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Horizon Pharma plc

GAAP to Non-GAAP Tax Rate Reconciliation (Unaudited)

(in millions, except percentages)

 

    Q1 2016  
    Pre-tax
Net
Income

(Loss)
    Income
Tax
Expense

(Benefit)
    Tax
Rate
    Net
Income
(Loss)
    Diluted
Earnings
(Loss)
Per
Share
 

As reported-GAAP

  $ (46.8   $ (1.4     3.1   $ (45.4   $ (0.28

Non-GAAP adjustments

    104.0        17.3          86.7     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 57.2      $ 15.9        27.7   $ 41.3      $ 0.25   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ (46.8   $ (1.4     3.1   $ (45.4   $ (0.28

Non-GAAP adjustments

    104.0        3.2          100.8     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 57.2      $ 1.8        3.0   $ 55.4      $ 0.34   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    Q2 2016  
    Pre-tax
Net
Income
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
    Diluted
Earnings
Per
Share
 

As reported-GAAP

  $ 12.2      $ (2.8     (22.5 )%    $ 15.0      $ 0.09   

Non-GAAP adjustments

    94.3        18.0          76.3     

Other Non-GAAP tax adjustment

    —          —            —       
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 106.5      $ 15.2        14.4   $ 91.3      $ 0.56   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ 12.2      $ (2.8     (22.5 )%    $ 15.0      $ 0.09   

Non-GAAP adjustments

    94.3        8.2          86.1     

Other Non-GAAP tax adjustment

    —          —            —       
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 106.5      $ 5.4        5.1   $ 101.1      $ 0.62   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    Q2 2016 YTD  
    Pre-tax
Net
Income

(Loss)
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
(Loss)
    Diluted
Earnings
(Loss)
Per
Share
 

As reported-GAAP

  $ (34.6   $ (4.2     12.1   $ (30.4   $ (0.19

Non-GAAP adjustments

    198.3        35.3          163.0     

Other Non-GAAP tax adjustment

    —          —            —       
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 163.7      $ 31.1        19.0   $ 132.6      $ 0.81   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ (34.6   $ (4.2     12.1   $ (30.4   $ (0.19

Non-GAAP adjustments

    198.3        11.4          186.9     

Other Non-GAAP tax adjustment

    —          —            —       
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 163.7      $ 7.2        4.4   $ 156.5      $ 0.96   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    Q1 2015  
    Pre-tax
Net
Income
(Loss)
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
(Loss)
    Diluted
Earnings
(Loss)
Per
Share
 

As reported-GAAP

  $ (17.6   $ 1.9        (10.8 )%    $ (19.5   $ (0.16

Non-GAAP adjustments

    42.4        0.2          42.2     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 24.8      $ 2.1        8.4   $ 22.7      $ 0.16   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ (17.6   $ 1.9        (10.8 )%    $ (19.5   $ (0.16

Non-GAAP adjustments

    42.4        (1.6       44.0     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 24.8      $ 0.3        1.1   $ 24.5      $ 0.18   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    Q2 2015  
    Pre-tax
Net
Income
(Loss)
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
(Loss)
    Diluted
Earnings
Per
Share
 

As reported-GAAP

  $ (128.9   $ (160.7     124.7   $ 31.8      $ 0.20   

Non-GAAP adjustments

    191.2        59.0          132.2     

Other Non-GAAP tax adjustment

    —          105.1          (105.1  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 62.3      $ 3.4        5.6   $ 58.9      $ 0.37   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ (128.9   $ (160.7     124.7   $ 31.8      $ 0.20   

Non-GAAP adjustments

    191.2        56.0          135.2     

Other Non-GAAP tax adjustment

    —          105.1          (105.1  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 62.3      $ 0.4        0.7   $ 61.9      $ 0.39   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    Q2 2015 YTD  
    Pre-tax
Net
Income
(Loss)
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
(Loss)
    Diluted
Earnings
Per
Share
 

As reported-GAAP

  $ (146.5   $ (158.8     108.4   $ 12.3      $ 0.08   

Non-GAAP adjustments

    233.6        59.2          174.4     

Other Non-GAAP tax adjustment

    —          105.1          (105.1  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 87.1      $ 5.5        6.4   $ 81.6      $ 0.56   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ (146.5   $ (158.8     108.4   $ 12.3      $ 0.08   

Non-GAAP adjustments

    233.6        54.4          179.2     

Other Non-GAAP tax adjustment

    —          105.1          (105.1  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 87.1      $ 0.7        0.8   $ 86.4      $ 0.60   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    Q3 2015  
    Pre-tax
Net
Income
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
    Diluted
Earnings
Per
Share
 

As reported-GAAP

  $ 25.2      $ 22.0        87.0   $ 3.2      $ 0.02   

Non-GAAP adjustments

    91.6        25.0          66.6     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 116.8      $ 47.0        40.2   $ 69.8      $ 0.42   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ 25.2      $ 22.0        87.0   $ 3.2      $ 0.02   

Non-GAAP adjustments

    91.6        (22.2       113.8     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 116.8      $ (0.2     (0.2 )%    $ 117.0      $ 0.70   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    Q3 2015 YTD  
    Pre-tax
Net
Income
(Loss)
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
(Loss)
    Diluted
Earnings
Per
Share
 

As reported-GAAP

  $ (121.3   $ (136.8     112.8   $ 15.5      $ 0.10   

Non-GAAP adjustments

    325.2        84.2          241.0     

Other Non-GAAP tax adjustment

    —          105.1          (105.1  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 203.9      $ 52.5        25.8   $ 151.4      $ 0.98   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ (121.3   $ (136.8     112.8   $ 15.5      $ 0.10   

Non-GAAP adjustments

    325.2        32.2          293.0     

Other Non-GAAP tax adjustment

    —          105.1          (105.1  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 203.9      $ 0.5        0.3   $ 203.4      $ 1.32   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    Q4 2015  
    Pre-tax
Net
Income

(Loss)
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
    Diluted
Earnings
Per
Share
 

As reported-GAAP

  $ (11.4   $ (35.4     309.3   $ 24.0      $ 0.15   

Non-GAAP adjustments

    119.5        38.0          81.5     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 108.1      $ 2.6        2.4   $ 105.5      $ 0.64   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ (11.4   $ (35.4     309.3   $ 24.0      $ 0.15   

Non-GAAP adjustments

    119.5        41.1          78.4     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 108.1      $ 5.7        5.2   $ 102.4      $ 0.63   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    FY 2015  
    Pre-tax
Net
Income

(Loss)
    Income
Tax
Expense
(Benefit)
    Tax
Rate
    Net
Income
(Loss)
    Diluted
Earnings
Per
Share
 

As reported-GAAP

  $ (132.7   $ (172.2     129.8   $ 39.5      $ 0.25   

Non-GAAP adjustments

    444.7        122.2          322.5     

Other Non-GAAP tax adjustment

    —          105.1          (105.1  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-new methodology

  $ 312.0      $ 55.1        17.7   $ 256.9      $ 1.65   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As reported-GAAP

  $ (132.7   $ (172.2     129.8   $ 39.5      $ 0.25   

Non-GAAP adjustments

    444.7        73.3          371.4     

Other Non-GAAP tax adjustment

    —          105.1          (105.1  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP-prior methodology

  $ 312.0      $ 6.2        2.0   $ 305.8      $ 1.96   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
 

 

20