ADVANZ PHARMA Corp. Limited Announces First Quarter 2021 Results

• First quarter 2021 revenue of $136 million
• First quarter 2021 net loss of $15 million
• First quarter 2021 Adjusted EBITDA¹ of $56 million
• Generated cash flow from operations of $13 million and concluded the quarter with a cash and cash equivalents balance of $135 million

LONDON, May 14, 2021 /CNW/ - ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA" or "the Company") (TSX: ADVZ), a global pharmaceutical company with a strategic focus on complex medicines in Europe, today announced its financial and operational results for the three months ended March 31, 2021. All financial references are in U.S. dollars ("USD") unless otherwise noted.

"Our first quarter results mark the third consecutive quarter of topline growth for the Company," said Graeme Duncan, Chief Executive Officer of ADVANZ PHARMA. "With respect to M&A, we continued to diversify our business during the reporting period with the acquisition of the global rights to Cyclophosphamide. We also strengthened our pipeline with the submission of three medicines for approval, and are pleased to have received the European DCP approval for Mytolac, our generic formulation of Lanreotide." 

Consolidated First Quarter 2021 Financial and Operational Results

• Reported first quarter 2021 revenue of $136.1 million, compared to $130.0 million for the first quarter of 2020, and $135.0 million for the fourth quarter of 2020.
• Reported a net loss for the first quarter of 2021 of $15.2 million.
• Reported first quarter 2021 Adjusted EBITDA¹ of $55.6 million, compared to $63.5 million for the first quarter of 2020, and $50.5 million for the fourth quarter of 2020.
• Generated cash flows from operating activities of $13.1 million in the first quarter of 2021 compared to $46.2 million in the first quarter of 2020.
• On January 29, 2021, the Company, through a wholly owned subsidiary, acquired the global rights to Cyclophosphamide 50mg tablets from Zenex Pharmaceuticals Pty Ltd for approximately $6.5 million.
• As of March 31, 2021, the Company had a cash and cash equivalents balance of $135.1 million, compared to $160.2 million as of December 31, 2020. The decrease in cash is primarily attributable to debt amortization and interest payments of $29.7 million, plus an upfront payment of approximately $5.0 million for the acquisition of global rights to Cyclophosphomide 50mg tablets. This decrease is partially offset by cash flows generated from operating activities of $13.1 million.

First Quarter 2021 Segment Results

International Segment

ADVANZ PHARMA International segment revenue for the quarter ended March 31, 2021, of $110.4 million increased by $13.4 million, or 14%, compared to the corresponding period in 2020. A $6.1 million increase in revenue was further compounded with a $7.4 million increase in revenue as a result of the GBP strengthening against the USD, when compared to the corresponding period in 2020. The increase in revenue is primarily due to $9.7 million of revenue from the portfolio of Alprostadil products sold within the ADVANZ PHARMA International segment, and $6.8 million of revenue from the Correvio Acquisition, due to the timing of these acquisitions in 2020.

The increase in revenue was partially offset, excluding the impact of foreign currency translation, by a $3.6 million decrease from Fusidic Acid; a $1.3 million decrease from Codeine Phosphate+Paracetamol; and a $1.3 million decrease from Levothyroxine Sodium.

These lower product volumes and revenues are primarily due to ongoing competitive market pressures resulting in market share erosion in the U.K., combined with phasing of shipments

North America Segment

ADVANZ PHARMA North America segment revenue of $25.7 million for the quarter ended March 31, 2021, decreased by $7.3 million, or 22%, compared to the corresponding period in 2020. The decrease was primarily due to a $6.7 million decrease from Plaquenil® largely as a result of increased demand in the comparative period of 2020 due to COVID-19; a $1.1 million decrease from Donnatal® due to continued competitive pressures impacting market share; and a $1.0 million decrease from Salagen® due to phasing of shipments.

These declines in revenue were partially offset by a $1.3 million increase from Photofrin due to impact of COVID-19 in the comparative period; and a $1.1 million increase from Zonegran®.

Pipeline Update  

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

In the first quarter of 2021, ADVANZ PHARMA submitted three medicines for approval. In addition, the Company received European decentralised procedure approval for Mytolac, its generic formulation of Lanreotide. The Company anticipates it will launch Mytolac in a number of European markets later this year.

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.  

Consolidated Financial Results

	Three months ended
(in $000's, except per share data)	Mar 31, 2021		Mar 31, 2020
Revenue	136,109		129,992
Gross profit	83,450		86,642
Gross profit %	61	%	67	%
Adjusted gross profit ^(1)	84,907		86,642
Adjusted gross profit % ^(1)	62	%	67	%
Total operating expenses	89,000		76,038
Operating (loss) income for the period	(5,550)		10,604
Income tax (recovery) expense	(3,221)		4,103
Net loss for the period	(15,243)		(8,686)
Loss per share
Basic	(0.31)		(0.18)
Diluted	(0.31)		(0.18)
EBITDA^(1)	47,940		70,360
Adjusted EBITDA ^(1)	55,575		63,489

Notes:
(1)	Represents a non-IFRS measure. For the relevant definitions and reconciliation to reported results, see "Non-IFRS Financial Measures" section of this press release. Management believes non-IFRS measures, including Adjusted Gross Profit and Adjusted EBITDA, provide supplementary information to IFRS measures used in assessing the performance of the business.

Consolidated Results of Operations

Revenue

Revenue for the first quarter of 2021 increased by $6.1 million, or 5%, compared to the corresponding period in 2020. This increase was due to higher sales from the ADVANZ PHARMA International segment combined with higher foreign exchange rates impacting translated revenues from this segment, partially offset by lower sales from the ADVANZ PHARMA North America segment.

Gross profit for the first quarter of 2021 decreased by $3.2 million, or 4%, compared to the corresponding period in 2020 primarily due to a shift in product mix and a non-cash inventory fair value adjustment increasing the cost of sales due to the fair value of inventory associated with the Correvio Acquisition amounting to $1.5 million.

Gross profit percentage for the first quarter of 2021 decreased by 6% to 61% compared to the corresponding period in 2020 primarily due to a change in the mix of product sales within both segments. As an example of that change, in the first quarter of 2020, the Company recorded greater sales of Plaquenil®, a higher-margin medicine for the Company, primarily as a result of increased demand due to COVID-19 .

Operating expenses of $89.0 million for the first quarter of 2021 increased by $13.0 million, or 17%, compared to the corresponding period in 2020. The increase in operating expenses is primarily due to $7.1 million higher impairment charges, $5.3 million higher acquisition related, restructuring and other costs, $3.1 higher general and administrative costs, and $2.7 million higher selling and marketing costs.

Operating expenses increases are partially offset by $6.0 million lower amortization charges on intangible assets.

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 first quarter of 2021 increased by $3.1 million, or 41%, compared to the corresponding period in 2020. The increase of $1.3 million is primarily attributable to the Correvio Acquisition as a result of timing of acquisition in 2020, combined with higher employee costs and foreign exchange rate movements negatively impacting translation of general and administrative costs from ADVANZ PHARMA International.

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 first quarter of 2021 increased by $2.7 million, or 34%, compared to the corresponding period in 2020, primarily due to an increase of $2.7 million, or 40%, within ADVANZ PHARMA International. The increase within ADVANZ PHARMA International is primarily as a result of costs associated with sales promotion and advertising activities of Correvio due to the timing of acquisition in 2020.

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 first quarter of 2021 increased by $0.4 million, or 5%, compared to the corresponding period in 2020 primarily due to the timing of Correvio Acquisition in 2020, combined with foreign exchange rate movements negatively impacting the translation of research and development costs from ADVANZ PHARMA International. This is partially offset by lower clinical trial spend, combined with lower costs associated with validation and stability testing activities.

First quarter 2021 Adjusted EBITDA of $55.6 million decreased by $7.9 million, or 12%, compared to the corresponding period in 2020. Adjusted EBITDA by segment for the first quarter of 2021 was $40.6 million  from ADVANZ PHARMA International and $17.7 million from ADVANZ PHARMA North America.

In addition, during the first quarter of 2021, the Company incurred $2.7 million of Corporate costs.

As of March 31, 2021, the Company had cash and cash equivalents of $135.1 million and 48,913,490 limited voting shares issued and outstanding. 

About ADVANZ PHARMA

ADVANZ PHARMA is a specialty pharmaceutical company with a strategic focus on complex medicines in Europe. With an agile and experienced team, including direct sales, marketing and medical capability across many of Europe's major markets, the Company supplies, innovates and enhances the critical medicines patients depend on, ensuring continued patient access and improving health outcomes.

ADVANZ PHARMA has expertise in the anti-Infectives and endocrinology therapy areas, along with strong relationships with hospital decision makers, making it an attractive partner when commercialising complex medicines in Europe.

ADVANZ PHARMA has an operational headquarters in London, an operations centre of excellence in Mumbai, commercial affiliates in North America, Europe, and Australia, and an established global network of commercial partners throughout the rest of the world.

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 Adjusted Gross Profit, EBITDA, Adjusted EBITDA and Working Capital, 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.

Adjusted Gross Profit

Adjusted Gross Profit is defined as gross profit adjusted for non-cash fair value increases to the cost of acquired inventory from a business combination. Under IFRS, acquired inventory is required to be recognized at fair value at the date of acquisition. As this inventory is sold, the fair value adjustment represents a non-cash cost of sale amount that has been excluded in adjusted gross profit in order to normalize gross profit for this non-cash component.

	Three months ended
(in $000's)	Mar 31, 2021		Mar 31, 2020
Gross profit per financial statements	83,450		86,642
Add back: Fair value adjustment to acquired inventory	1,457		—
Adjusted Gross Profit	84,907		86,642

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, change in assumed contingent obligation 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 month periods ended March 31, 2021, and March 31, 2020.

	Three months ended
(in $000's)	Mar 31, 2021		Mar 31, 2020
Net loss for the period	(15,243)		(8,686)
Interest and accretion expense	24,953		27,552
Interest income	(443)		(504)
Income taxes	(3,221)		4,103
Depreciation	748		724
Amortization of intangible assets	41,146		47,171
EBITDA	47,940		70,360
Impairments	7,100		—
Fair value adjustment to acquired inventory	1,457		—
Acquisition related, restructuring and other	9,579		4,266
Share-based compensation expense	1,095		724
Foreign exchange loss	1,191		245
Unrealized foreign exchange gain	(8,349)		(12,106)
Change in assumed contingent obligation	(4,438)		—
Adjusted EBITDA	55,575		63,489

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 Forward-looking Statements and Information:

This news release includes forward-looking statements and forward-looking information within the meaning of Canadian securities laws. Often, but not always, 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 and information 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 and information 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, the pharmaceutical industry and the regulation thereof, regulatory investigations and proceedings, the failure to comply with applicable laws, risks associated with distribution agreements, risks associated with general economic factors and 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, risks related to the spread of COVID-19 (including, without limitation, risks associated with reliance on third party manufacturers and suppliers, uncertainties relating to its ultimate spread, severity and duration, and related adverse effects on the economies and financial markets of many countries), 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.

For media inquiries, please contact: Meral Nugent, ADVANZ PHARMA Corp. Limited, [phone], [email protected]; For investor inquiries, please contact: Adam Peeler, on behalf of: ADVANZ PHARMA Corp. Limited, 416.427.1235, [email protected]

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