Concordia Healthcare Announces Third Quarter Results - Revenue up 147%, EBITDA up 80% Over Comparative Period

TORONTO, Nov. 13, 2014 /CNW/ - Concordia Healthcare Corp. ("Concordia" or the "Company") (TSX: CXR) (OTCQX: CHEHF), a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population, today announced its financial and operational results for the three and nine months ended September 30, 2014.

All financial references are in U.S. dollars unless otherwise noted.

Financial Results

Third Quarter 2014 Highlights

• Third quarter, 2014 revenue increase of 147 per cent compared to the third quarter of 2013;
• Third quarter, 2014 adjusted EBITDA up 137 per cent versus the same period in 2013;
• On September 30, 2014, the Company announced its subsidiary, Concordia Pharmaceuticals Inc. (CPI), completed the acquisition of Zonegran® (zonisamide) for commercialization and sale in the United States, including Puerto Rico. CPI acquired Zonegran® from Eisai Inc. for US$91.4 million in cash, including approximately US$1.4 million for purchased inventory. The acquisition of Zonegran® further diversifies Concordia's growing pipeline of legacy drugs.
• Concordia's board of directors approved a $0.075 dividend per common share.  A record date of January 15, 2015 was declared by the board of directors with a distribution of proceeds expected to occur on January 31, 2015.  Declarations and payments will be made in U.S. dollars.  All future quarterly dividends will be subject to quarterly financial review and board approval.
• On August 11, 2014, the Company announced that its subsidiary Pinnacle Biologics, Inc. enrolled the first group of patients in a randomized Phase 2 trial to evaluate photodynamic therapy (PDT) with PHOTOFRIN® for patients with epithelioid malignant pleural mesothelioma. The study is expected to enroll 102 patients over four years, and is being supported by an $8 million grant from the National Cancer Institute.
• On August 5, 2014, the Company and Pinnacle Biologics, Inc. announced the initiation of a randomized Phase 3 clinical trial to treat a rare form of bile duct cancer for which there currently is no acceptable therapy. The trial is studying the efficacy and safety of PDT with PHOTOFRIN® for injection as treatment for unresectable advanced perihilar cholangiocarcinoma Bismuth type III/IV.

Going forward, Concordia plans to grow its businesses by:

• supplementing its existing portfolio by acquiring or in-licensing additional legacy products;
• developing PHOTOFRIN® for new indications including cholangiocarcinoma;
• acquiring additional orphan drugs; and
• expanding its Specialty Healthcare Distribution Division by distributing additional products.

"The successful integration of Donnatal® into our growing portfolio of legacy pharmaceutical products helped drive Concordia's top and bottom line financial growth for the third quarter," said Mark Thompson, Chief Executive Officer of Concordia. "Looking ahead, we are excited about Zonegran®'s upside, and we remain focussed on potential M&A opportunities that could further diversify our pipeline of high-margin assets."  

Third Quarter 2014 Financial Results

The Company's net revenue was $36,432,000 and $79,295,000 for the three and nine months ended September 30, 2014, respectively, while gross profit for the same periods was $31,936,000 and $66,391,000.

Net revenue and gross profit are derived from Concordia's Legacy Pharmaceuticals Division, its Orphan Drugs Division, and its Specialty Healthcare Distribution.

Legacy Pharmaceuticals Division

Legacy Pharmaceuticals Division revenue in the third quarter of 2014 was $29.2 million, compared to $14.7 million in the third quarter of 2013.  The acquisition of Donnatal® accounted for the majority of the increase in revenue over the same quarter in 2013.  The impact of Donnatal® was partially offset by the expected decline in revenue from Kapvay® due to the loss of exclusivity on the product in the fourth quarter of 2013.

Legacy Pharmaceuticals gross profit for the third quarter of 2014 was $26.2 million compared to $12.1 million in the prior year comparable period. The increase of $14.1 million was primarily due to sales growth in the division, with the acquisition of Donnatal® accounting for the majority of the increase.  Legacy Pharmaceuticals gross margin in the third quarter of 2014 was 89.8% compared with 82.5% in 2013. The increase in gross margin is primarily driven by the Donnatal® acquisition.

Legacy Pharmaceuticals revenue for the nine months ended September 30, 2014 increased by $34.3 million over the prior year comparable period. Revenue in 2014 reflects a full three quarters of operations, compared to less than two quarters of operations in 2013. Gross profit for the nine months ended September 30, 2014 increased by $29.4 million over the same period in the prior year.

Cost of sales for the three months ended September 30, 2014 and 2013 were $3.0 million and $2.6 million, respectively, and reflect the costs of active pharmaceutical ingredients, excipients, packaging, freight costs and royalties. Cost of sales was $9.2 million and $4.3 million for the nine months ended September 30, 2014 and 2013, respectively.

Orphan Drugs Division

Net revenues for the Orphan Drugs Division were $3.0 million and $7.4 million for the three months and nine months ended September 30, 2014, respectively. Orphan Drugs revenue represents the sales of Photofrin® lasers and fibers. Orphan Drugs revenue for the first nine months of 2014 was impacted in the second quarter of 2014 by a reduction in end user inventory of Photofrin® as hospitals continue to optimize inventory holdings, and by a product expiry issue which required the Company to replace certain channel inventory at no cost. Revenue in the third quarter of 2014 recovered to a level consistent with the first quarter of 2014.

Cost of sales for the three months ended September 30, 2014 was $0.8 million. Cost of sales for the nine months ended September 30, 2014 of $1.1 million includes a reversal of a take-or-pay provision of $0.6 million in the second quarter of 2014.  During the second quarter the Company, in consultation with external advisors, determined that it did not have an obligation to pay its manufacturer for the provision.

Gross profits were $2.3 million and $6.3 million for the three months and nine months ended September 30, 2014, respectively.

Specialty Healthcare Distribution Division

Net revenues for the Specialty Healthcare Distribution division were $4.2 million and $13.8 million for the three months and nine months ended September 30, 2014, respectively, and related primarily to sales and distribution of diabetes testing supplies and orthotics for diabetic patients.

Costs of sales for the three months ended September 30, 2014 were $0.7 million and $2.6 million for the nine months ended September 30, 2014 and related to the cost of products, warehousing and freight.

Gross profits were $3.5 million and $11.2 million for the three months and nine months ended September 30, 2014, respectively.

Overall for the Company, operating income was $14,868,000 and $22,538,000 for the three and nine months ended September 30, 2014. For the three months ended September 30, 2013, operating income was $7,897,000.

Operating expenses were $17,068,000 and $43,853,000 for the three months and nine months ended September 30, 2014. For the three months ended September 30, 2013, operating expenses were $4,250,000.

Net cash provided by operating activities was $136,000 for the three months ended September 30, 2014 and net cash used in operating activities was $9,259,000 for nine months ended September 30, 2014. For the three months ended September 30, 2013, net cash provided by operating activities was $9,857,000.

As at September 30, 2014 and November 13, 2014 the Company had 28,861,239 common shares issued and outstanding. As at September 30, 2014 and November 13, 2014, there were 2,002,280 options outstanding that entitle the holders thereof to purchase one common share per option of the Company.

Conference Call Notification 

Management will host a conference call to discuss the third quarter, 2014 results on Friday, November 14, 2014 at 8:30 am ET. Following management's presentation, there will be a question-and-answer session. To participate in the conference call, please dial (888) 231-8191 or (647) 427-7450.

A digital conference call replay will be available until midnight on November 28, 2014 (ET) by calling (416) 849-0833 or (855) 859-2056. Please enter the password 25637087 when instructed. A webcast replay will be available for 365 days by accessing a link through the Events section at visit www.concordiarx.com

About Concordia

Concordia is a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population. Concordia's legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of the following products: ADHD-treatment Kapvay® (clonidine extended release tablets), head lice treatment Ulesfia® (benzyl alcohol) Lotion, asthma-related medication Orapred ODT® (prednisolone sodium phosphate orally disintegrating tablets), irritable bowel syndrome treatment Donnatal® (belladonna alkaloids, phenobarbital) and Zonegran® (zonisamide) for treatment of partial seizures in adults with epilepsy. Concordia's specialty healthcare distribution (SHD) division, Complete Medical Homecare, distributes medical supplies targeting diabetes and related conditions. Concordia's orphan drugs division, Concordia Laboratories Inc., manufactures PHOTOFRIN®. PHOTOFRIN® is marketed by Pinnacle Biologics, Inc. in the United States.

Concordia operates out of facilities in Oakville, Ontario; Bridgetown, Barbados; Lenexa, Kansas; Chicago, Illinois and Charlottesville, Virginia.

¹As used herein, EBITDA is defined as net income adjusted for net interest expense, income tax expense, depreciation and amortization. Management uses EBITDA to assess the Company's operating performance.

²As used herein, adjusted EBITDA is defined as EBITDA adjusted for one-time charges associated with acquisitions, one-time charges associated with the Company's listing on the TSX, non-cash items such as unrealized gains / losses on derivative instruments, change in fair value of contingent consideration, other income expenses, share-based compensation and realized / unrealized gains/losses related to foreign exchange revaluation. Management uses adjusted EBITDA as a 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.

Non-IFRS Measures

This press release makes reference to certain non-IFRS measures. 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 as 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 for analyses of the Company's financial information reported under IFRS.  Management uses non-IFRS measures such as EBITDA and Adjusted EBITDA to provide investors with a supplemental measure 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 also 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, and to assess its ability to meet future debt service, capital expenditure, and working capital requirements.

Notice regarding forward-looking statements:

This release includes forward-looking statements regarding Concordia and its business, which may include, but are not limited to, the impact of the acquisition of pharmaceutical products on Concordia's financial performance, the revenue-generating capabilities and/or potential of Concordia's assets, Concordia's financial strength, the ability of Concordia's products and/or business divisions to generate a stable revenue stream for the development of products and/or acquisition opportunities, the continued and/or expected profitability of Concordia's products and/or services, the payment of dividends in respect of Concordia's common shares, Concordia's growth, the expansion into new indications for Concordia's existing and/or future products, the acquisition of additional products and/or assets (including orphan drugs and legacy products), in-licencing additional products, the distribution of additional products, the addition of new sites approved to enroll patients into clinical trials, the ability to obtain necessary approvals, the approval and development of PDT with PHOTOFRIN® as a new treatment for certain forms of cancer, the ability of PDT with PHOTOFRIN® to combat certain forms of cancer, enrollment of patients into clinical trials, the outcomes and success of clinical trials and other factors.  Often, but not always, forward-looking statements 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 Concordia's management, and are based on assumptions and subject to risks and uncertainties.  Although Concordia'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 release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks regarding clinical trials and/or patient enrollment into clinical trials, risks relating to the use of Concordia's products to treat certain diseases, the pharmaceutical industry, the failure to obtain regulatory approvals, risks associated with the acquisition of pharmaceutical products, economic factors, market conditions, acquisition opportunities, the inability to complete acquisitions, the equity markets generally, risks associated with growth and competition and many other factors beyond the control of Concordia.  Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

SOURCE Concordia Healthcare Corp.