ADVANZ PHARMA Corp. Announces Third Quarter 2019 Results

• Third quarter 2019 revenue of $120 million
• Third quarter 2019 net loss of $119 million
• Third quarter 2019 Adjusted EBITDA¹ of $56 million
• Generated cash flows from operating activities of $151 million in the first nine months of 2019, compared to $98 million during the same period in 2018

TORONTO, Nov. 7, 2019 /CNW/ - ADVANZ PHARMA Corp. ("ADVANZ PHARMA" or "the Company") ADVZ, an international specialty pharmaceutical company focused on serving the needs of patients and healthcare providers around the world with enhanced access to high quality, niche-established medicines, today announced its financial and operational results for the three and nine months ended September 30, 2019. All financial references are in U.S. dollars ("USD") unless otherwise noted.

"During our third quarter, the Company expedited the evaluation of several M&A opportunities, we further developed our pipeline and launched new medicines, and we delivered financial results that are consistent with our targets," said Graeme Duncan, Chief Executive Officer of ADVANZ PHARMA.

Consolidated Third Quarter 2019 Financial and Operational Results

• Reported third quarter 2019 revenue of $119.6 million, compared to $127.7 million for the third quarter of 2018, and $131.1 million for the second quarter of 2019.
• Reported a net loss for the third quarter of 2019 of $119.2 million.
• Reported third quarter Adjusted EBITDA¹ of $55.9 million, compared to $59.0 million for the third quarter of 2018, and $59.7 million for the second quarter of 2019.
• Generated cash flows from operating activities of $150.9 million in the first nine months of 2019, compared to $98.1 million during the same period in 2018.
• As of September 30, 2019, the Company had a cash and cash equivalents balance of $243.3 million compared to $224.4 million as of December 31, 2018.

Third Quarter 2019 Segment Results

International Segment

ADVANZ PHARMA International segment revenue of $90.1 million for the quarter ended September 30, 2019, decreased by $1.8 million or 2%, compared to the corresponding period in 2018.

A $5.1 million decrease in revenue as a result of the GBP weakening against the USD was partially offset by $3.3 million higher revenue as a result of key product volume increases. Increases in revenue attributable to key products during the quarter, excluding the impact of foreign currency translation, included a $1.3 million increase from Fusidic Acid, a $1.2 million increase from Acetylsalicyclic Acid, and a $0.9 million increase from Flurbiprofen.

These increases to revenue were partially offset by lower revenues due to ongoing competitive market pressures resulting in market share erosion in the U.K.

Decreases to revenue attributable to key products during the quarter, excluding the impact of foreign currency translation, consisted of a $0.5 million decrease from Carbimazole, a $0.4 million decrease from Cyclizine Hydrochloride, and a $0.3 million decrease from Nitrofurantoin.

North America Segment

ADVANZ PHARMA North America segment revenue of $29.5 million for the quarter ended September 30, 2019, decreased by $6.2 million or 17%, compared to the corresponding period in 2018.

The decrease was primarily due to a $4.5 million decrease from Donnatal®, as a result of competitive pressures that have resulted in a loss of market share, a $2.2 million decrease from Plaquenil® authorized generic due to additional competitive product pricing, and a $1.2 million decrease from Kapvay® due to decline in product volumes.

These declines were partially offset by a $1.6 million increase from Zonegran®, and a $1.1 million increase from recently acquired Salagen® and Panretin® brands in the U.S.

Pipeline Update  

The Company continued to make progress with respect to the evaluation and advancement of its pipeline of medicines.

In the third quarter of 2019, ADVANZ PHARMA submitted for approval, or received approval, for seven  medicines.

Going forward, the Company intends to expand its product portfolio in order to deliver mid-term value and long-term growth, through pipeline filling, optimization, licencing and development partnerships. These initiatives will be focussed on niche and differentiated generics, complex specialty and value-added medicines.  

For 2019, the Company continues to believe that product launches from its pipeline will not generate a material amount of revenue.

 Consolidated Financial Results

Consolidated Results of Operations

Revenue for the third quarter of 2019 and year to date decreased by $8.0 million, or 6%, and $33.1 million, or 8%, respectively, compared to the corresponding periods in 2018.

Revenue for the third quarter of 2019 was lower primarily due to lower revenue from the ADVANZ PHARMA North America segment. Revenue year to date was lower primarily due to lower sales from both segments, combined with lower foreign exchange rates impacting translated revenues of ADVANZ PHARMA International segment.

Gross profit for the third quarter of 2019 and year to date decreased by $5.8 million, or 7%, and $25.4 million, or 9%, respectively, compared to the corresponding periods in 2018, primarily due to segment revenue declines.

Gross profit percentage for the third quarter of 2019 and year to date was consistent with the corresponding periods in 2018. The consistent gross profit as a percentage of revenue is a net result of higher gross profit as a percentage of revenue reflecting the impact of the Medicaid Exit and 340B Pricing Termination, offset by lower gross profit as a percentage of revenue due to a shift in product mix.

Operating expenses for the third quarter of 2019 increased by $57.1 million, or 42%, and decreased by $12.4 million, or 3%, for the year to date 2019, compared to the corresponding periods in 2018.

The increase in operating expenses for the third quarter of 2019 is primarily due to $108.3 million higher impairment charges, partially offset by $38.8 million lower restructuring related, acquisition and other costs mainly associated with the Company's Recapitalization Transaction in 2018, and $9.4 million lower amortization charges on intangible assets.

Operating expenses were lower for the year to date 2019, compared to corresponding period in 2018, primarily due to $74.5 million lower restructuring related, acquisition and other costs mainly associated with the Company's Recapitalization Transaction in 2018, $32.3 million lower amortization charges on intangible assets, partially offset by $100.3 million higher impairment charges.

General and administrative expenses reflect costs related to salaries and benefits, professional and consulting fees, public company costs, travel and other administrative expenditures. General and administrative expenses for the third quarter of 2019 and year to date decreased by $0.8 million, or 8%, and $3.1 million, or 10%, respectively, compared to the corresponding periods in 2018.

These decreases are primarily due to lower costs of $0.6 million and $2.2 million, respectively, associated with lease payments recorded in general and administrative expenses as a result of the revised accounting for these costs due to the adoption of IFRS 16 on January 1, 2019, combined with favourable foreign exchange rate movements impacting translation of general and administrative expenses from ADVANZ PHARMA International, partially offset by increased legal costs within ADVANZ PHARMA North America associated with claims brought against the non-FDA approved competitors of Donnatal®.

Selling and marketing expenses reflect costs incurred by the Company for the marketing, promotion and sale of its portfolio of products across its segments. Selling and marketing costs for the third quarter of 2019 and year to date decreased by $1.4 million, or 15%, and $4.8 million, or 16%, respectively, compared to the corresponding periods in 2018.

Research and development expenses reflect costs for clinical trial activities, product development, professional and consulting fees and services associated with the activities of the medical, clinical and scientific affairs, quality assurance costs, regulatory compliance and drug safety costs (pharmacovigilance) of the Company. Research and development costs for the third quarter of 2019 decreased by $0.5 million, or 6%, compared to the corresponding period in 2018 primarily due to lower clinical trial spend, combined with favourable foreign exchange rate movements impacting translation of research and development costs from ADVANZ PHARMA International. Research and development costs for the year to date 2019 decreased by $0.5 million, or 2%, primarily due to the reasons described above, combined with lower costs associated with validation and stability testing activities within ADVANZ PHARMA International, offset by refunds of regulatory fees within ADVANZ PHARMA North America in the corresponding period of 2018.

Adjusted EBITDA for the third quarter of 2019 and year to date decreased by $3.0 million, or 5% and $17.0 million, or 9%, compared to the corresponding periods in 2018. These declines are primarily due to lower sales and gross profits from both the segments, combined with lower foreign exchange rates impacting translated results of ADVANZ PHARMA International segment.

In addition, during the third quarter of 2019 and year to date the Company incurred $3.1 million and $9.5 million, respectively, of Corporate costs. Corporate expenses for the third quarter of 2019 and year to date increased by $0.6 million and $0.4 million, respectively, compared to the corresponding periods in 2018.

As of September 30, 2019, the Company had cash and cash equivalents of $243.3 million and 48,913,490 limited voting shares issued and outstanding. 

Conference Call Notification

The Company will hold a conference call on Thursday, November 7, 2019, at 8:30 a.m. ET hosted by senior management. A question-and-answer session will follow the corporate update.

This call is being webcast and can be accessed by going to:

https://event.on24.com/wcc/r/2116940/603F471B4E88EA30941C4FC69795A15D

An archived replay of the webcast will be available by clicking the link above.

About ADVANZ PHARMA

ADVANZ PHARMA operates an international specialty pharmaceutical business with a diversified portfolio of more than 200 patented and off-patent products, and sales in more than 90 countries, and going forward, is focused on becoming the leading platform for niche-established medicines, with advanced commercial capabilities throughout Western Europe.

ADVANZ PHARMA operates out of facilities in Toronto, Ontario and, through its subsidiaries, operates out of facilities in Sydney, Australia; London, England; Mumbai, India; Dublin, Ireland; St. Helier, Jersey; and in Helsingborg, Sweden.

Non-IFRS Financial Measures

This press release makes reference to certain measures that are not recognized measures under International Financial Reporting Standards ("IFRS").  These non-IFRS measures are not recognized measures under IFRS and do not have a standardized meaning prescribed by IFRS, and are therefore unlikely to be comparable to similar measures presented by other companies. When used, these measures are defined in such terms to allow the reconciliation to the closest IFRS measure. These measures are provided as additional information to complement those IFRS measures by providing further understanding of the Company's results of operations from management's perspective. Accordingly, they should not be considered in isolation nor as a substitute to the Company's financial information reported under IFRS. Management uses non-IFRS measures such as EBITDA, and Adjusted EBITDA, to provide investors with supplemental information of the Company's operating performance and thus highlight trends in the Company's core business that may not otherwise be apparent when relying solely on IFRS financial measures. Management believes that securities analysts, investors and other interested parties frequently use non-IFRS measures in the evaluation of issuers. Management also uses non-IFRS measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets, to assess its ability to meet future debt service requirements, in making capital expenditures, and to consider the business's working capital requirements. Readers are cautioned that the non-IFRS measures contained herein may not be appropriate for any other purpose.

EBITDA

EBITDA is defined as net income (loss) adjusted for interest and accretion expense, interest income, income taxes, depreciation and amortization of intangible assets. Management uses EBITDA to assess the Company's operating performance.

Adjusted EBITDA

Adjusted EBITDA is defined as EBITDA adjusted for certain charges including costs associated with acquisitions, restructuring initiatives, and other costs (which includes onerous contract costs and direct costs associated with contractual terminations), management retention costs, non-operating gains / losses, integration costs, legal settlements (net of insurance recoveries) and related legal costs, non-cash items such as unrealized gains / losses on derivative instruments, share based compensation expense/recovery, fair value changes including purchase consideration and derivative financial instruments, asset impairments, fair value increases to inventory arising from purchased inventory from a business combination, gains / losses from the sale of assets and unrealized gains / losses related to foreign exchange.  Management uses Adjusted EBITDA, among other non-IFRS financial measures, as the key metric in assessing business performance when comparing actual results to budgets and forecasts.  Management believes Adjusted EBITDA is an important measure of operating performance and cash flow, and provides useful information to investors because it highlights trends in the underlying business that may not otherwise be apparent when relying solely on IFRS measures.

The table below sets forth the reconciliation of net income (loss) to EBITDA and to Adjusted EBITDA for the three and nine month periods ended September 30, 2019, and September 30, 2018.

Notice Regarding Trademarks

This press release includes trademarks that are protected under applicable intellectual property laws and are the property of ADVANZ PHARMA or its affiliates or its licensors. Solely for convenience, the trademarks of ADVANZ PHARMA, its affiliates and/or its licensors referred to in this press release may appear with or without the ® or TM symbol, but such references or the absence thereof are not intended to indicate, in any way, that the Company or its affiliates or licensors will not assert, to the fullest extent under applicable law, their respective rights to these trademarks. Any other trademarks used in this press release are the property of their respective owners.

Notice regarding future-oriented financial information:

To the extent any forward-looking statements or forward-looking information in this press release or in statements made during the corresponding earnings conference call constitute future-oriented financial information or financial outlooks within the meaning of applicable securities laws, such information is being provided to demonstrate the potential financial performance of the Company and readers are cautioned that this information may not be appropriate for any other purpose and that they should not place undue reliance on such future-oriented financial information and financial outlooks.

Future-oriented financial information and financial outlooks (collectively, "FOFI"), as with forward-looking statements and forward-looking information generally, are, without limitation, based on the assumptions and subject to the risks set out below under "Notice Regarding Forward-Looking Statements", a number of which are beyond the Company's control. In addition, the following is summary of the significant assumptions underlying the FOFI contained in the Company's earnings disclosure:

• prescription trends;
• pricing for the Company's products;
• future market demand trends;
• mix of sales to government and non-government customers;
• gross profits for each product;
• foreign currency rates, including translation between the U.S. dollar and the British pound;
• inventory levels;
• operating cost estimates;
• ability to develop and market future product launches;
• anticipated timing of future product launches;
• cost to develop future products;
• anticipated timing to exit markets;
• operating cost synergies realized; and
• annual cost of current tax by jurisdiction

The FOFI do not purport to present the Company's financial condition in accordance with IFRS, and there can be no assurance that the assumptions made in preparing the FOFI will prove accurate. It is expected that there will be differences between actual and forecasted results, and the differences may be material, including due to the occurrence of unforeseen events occurring subsequent to the preparation of the FOFI. The inclusion of the FOFI in the earnings disclosure should not be regarded as an indication that ADVANZ PHARMA considers the FOFI to be a reliable prediction of future events, and the FOFI should not be relied upon as such.

Risks and other factors related to FOFI include those risks and other factors referenced in this press release as well as in ADVANZ PHARMA's filings with the Canadian Securities Administrators, including (a) the factors described under the heading "Forward-looking Statements" in ADVANZ PHARMA's Management's Discussion and Analysis dated November 7, 2019, for the period ended September 30, 2019.

The Company anticipates that its Management's Discussion and Analysis will be available online at www.sedar.com on November 7, 2019.

¹ Management uses non-IFRS measures such as EBITDA and Adjusted EBITDA to provide a supplemental measure of operating performance. Please refer to the "Non-IFRS Measures" section of this press release for further information.

Notice Regarding Forward-looking Statements and Information:

This news release includes forward‐looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward‐looking information within the meaning of Canadian securities laws, regarding ADVANZ PHARMA and its business, which may include, but are not limited to, statements with respect to ADVANZ PHARMA's focus on serving the needs of patients and healthcare providers around the world with niche-established medicines, statements with respect to ADVANZ PHARMA's long-term growth strategy and refined strategic direction, ADVANZ PHARMA's outlook for 2019, ADVANZ PHARMA's intention to expand its product portfolio in order to deliver mid-term value and long-term growth through pipeline filling, optimization, licencing and development partnerships, its focus on niche and differentiated generics, complex speciality and value-added medicines, ADVANZ PHARMA's financial performance (including the performance of its operating segments), and the Company's belief that product launches from its pipeline will not generate a material amount of revenue. Often, but not always, forward‐looking statements and forward‐looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of ADVANZ PHARMA's management, and are based on assumptions and subject to risks and uncertainties. Although ADVANZ PHARMA's management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward‐looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting ADVANZ PHARMA, including risks associated with ADVANZ PHARMA's securities, increased indebtedness and leverage, ADVANZ PHARMA's growth, risks associated with the use of ADVANZ PHARMA's products, the inability to generate cash flows, revenues and/or stable margins, the inability to repay debt and/or satisfy future obligations, risks associated with a delay in releasing ADVANZ PHARMA's financial statements (which could result in a default under ADVANZ PHARMA's debt agreements and a violation of applicable laws), ADVANZ PHARMA's outstanding debt, risks associated with the geographic markets in which ADVANZ PHARMA operates and/or distributes its products, risks associated with distribution agreements, the pharmaceutical industry and the regulation thereof, regulatory investigations, the failure to comply with applicable laws, economic factors, market conditions, risks associated with growth and competition, the failure to obtain regulatory approvals, the equity and debt markets generally, general economic and stock market conditions, risks associated with fluctuations in exchange rates (including, without limitation, fluctuations in currencies), political risks (including changes to political conditions), risks associated with the United Kingdom's exit from the European Union (including, without limitation, risks associated with regulatory changes in the pharmaceutical industry, changes in cross‐border tariff and cost structures and the loss of access to the European Union global trade markets), risks related to patent infringement actions, the loss of intellectual property rights, risks and uncertainties detailed from time to time in ADVANZ PHARMA's filings with the Canadian Securities Administrators, and many other factors beyond the control of ADVANZ PHARMA. Although ADVANZ PHARMA has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward‐looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward‐looking statement or information can be guaranteed. Except as required by applicable securities laws, forward‐looking statements and information speak only as of the date on which they are made and ADVANZ PHARMA undertakes no obligation to publicly update or revise any forward‐looking statement or information, whether as a result of new information, future events, or otherwise.

SOURCE ADVANZ PHARMA Corp.

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