Novelion Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results
- Novelion reports 2017 total net revenues of
$138.4 million, in line with previously stated guidance
- Plans underway to address capital structure and advance metreleptin development program
Chief Operating Officer
- JUXTAPID: Novelion reported net revenues of JUXTAPID of
$20.1 millionin the fourth quarter of 2017, $14.2 million, or 71%, of which were from prescriptions written in the U.S.
- MYALEPT: Novelion reported net revenues
of MYALEPT of
$18.8 millionin the fourth quarter of 2017, $13.3 million, or 71%, of which were from prescriptions written in the U.S.
- Novelion reported total consolidated net revenues of
$138.4 millionfor the year ended December 31, 2017.
- Novelion ended 2017 with
$55.4 millionin unrestricted cash, compared with $70.5 millionat the end of the third quarter of 2017.
- As announced separately today, subsidiary
Aegerion Pharmaceuticalsentered into a new secured financing facility with affiliates of Sarissa Capital Managementand Broadfin Capital LLCproviding for a $20 millionterm loan to Aegerion, strengthening Aegerion's balance sheet and liquidity, and positioning the Company for ongoing capital structure review.
January 2018, Novelion undertook significant cost reduction plans as it continues to manage its limited cash resources.
- With respect to its European application to register metreleptin for marketing authorization, after taking into account the results of an oral hearing of the European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP"), which occurred in
February 2018, the Company expects the opinion of the CHMP in the second quarter of 2018 and the European Commission's approval decision in mid-2018.
Fourth Quarter 2017 Financial Results
GAAP total net revenues for the fourth quarter of 2017 were
GAAP total operating expenses for the fourth quarter of 2017 were
On a pro forma basis, during the fourth quarter of 2017, SG&A expenses were
On a pro forma basis, during the fourth quarter of 2017, R&D expenses were
GAAP net loss in the fourth quarter of 2017 was
On a pro forma basis, net loss in the fourth quarter of 2017 was
Full Year 2017 Financial Results
GAAP total net revenues for the year ended
GAAP total operating expenses for the year ended
Cost of product sales were
On a pro forma basis, for the year ended
GAAP net loss for the year ended
On a pro forma basis, net loss for the year ended
The non-GAAP results in this press release, including, without limitation, non-GAAP net revenues, non-GAAP operating expenses, non-GAAP R&D expenses, non-GAAP SG&A expenses and non-GAAP net loss, are provided as a complement to results provided in accordance with GAAP because management believes, when considered together with the GAAP information, these non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial performance. In particular, management believes that the pro forma financial information facilitates the evaluation of the impact of Novelion's acquisition of Aegerion on the business and performance of the Company. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, and to manage the Company's business and evaluate its performance. The non-GAAP financial measures have no standardized meaning under GAAP and therefore may not be comparable to similar measures presented by other companies. The non-GAAP financial measures are not intended to be considered in isolation or as a substitute for, or superior to, the financial measures prepared and presented in accordance with GAAP and should be reviewed in conjunction with the relevant GAAP financial measures. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.
Certain statements in this press release constitute "forward-looking statements" of Novelion within the meaning of
applicable laws and regulations and constitute "forward-looking information" within the meaning of applicable securities laws. Any statements contained herein which do not describe historical facts, including statements regarding expectations and beliefs about the Company's near-term plans and the Company's position for sustainable future growth; expectations as to the opinion of the CHMP and the European Commission's approval decision, including timing; expectations that the cost of product sales for metreleptin will increase in 2018 and for the next several years; and our capital structure review are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, risks associated with Aegerion's previously disclosed criminal
plea agreement and other government settlement arrangements (including the government's recitation of their assessment of the background of its case, the settlement itself and publicity related to the settlement), the risk that the government investigations and the settlement will give rise to third party demands, claims or litigation that could materially and adversely impact our results of operations, including demands or claims by, or litigation with, third party payers, healthcare providers, or patients or investors, for matters related to the subject matter of or disclosure in connection with the investigation or the settlement, the likelihood that the investigation could lead to potential investigations, claims or litigation by consumer protection agencies or groups, or provide a basis for product liability claims or litigation and the adverse effects the investigation and
settlement could have on Aegerion's commercial operations and contracts, along with those risks identified in our filings with the
This press release also contains "forward-looking information" that constitutes "financial outlooks" within the meaning of applicable Canadian securities laws. This information is provided to give investors general guidance on management's current expectations of certain factors affecting our business, including our financial results. Given the uncertainties, assumptions and risk factors associated with this type of information, including those described above, investors are cautioned that the information may not be an appropriate subject of reliance for other purposes.
Investors and others should note that we communicate with our investors and the public using our company website, www.novelion.com, including, but not limited to, company disclosures, investor presentations and FAQs,
JUXTAPID® (lomitapide) capsules is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). LIMITATIONS OF USE: The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.
JUXTAPID can cause elevations in transaminases, as well as increases in hepatic fat, with or without concomitant increases in transaminases. Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted distribution program called the JUXTAPID REMS PROGRAM. For more detailed information, please see additional Important Safety Information and the Prescribing Information for JUXTAPID.
MYALEPT® (metreleptin) for injection is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. LIMITATIONS OF USE: The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy or for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established.
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with MYALEPT. For more detailed information, please see additional Important Safety Information and the Prescribing Information for MYALEPT.
Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three Months Ended ||Year Ended |
|Cost of product sales||16,993||5,971||77,220||5,971|
|Selling, general and administrative||24,111||15,953||96,472||29,525|
|Research and development||11,772||6,010||49,008||14,784|
|Total operating expenses||35,879||21,963||148,016||44,309|
|Loss from operations||(13,964||)||(14,360||)||(86,798||)||(36,706||)|
|Interest expense, net||(10,315||)||(3,200||)||(39,037||)||(2,960||)|
|Fair value loss on investment||—||—||—||(10,740||)|
|Other expense, net||(468||)||(1,791||)||(292||)||(1,999||)|
|Loss before provision for income taxes||(24,747||)||(19,351||)||(126,127||)||(52,405||)|
|Benefit (Provision) for income taxes||179||(569||)||(583||)||(465||)|
|Net loss per common share—basic and diluted||$||(1.32||)||$||(1.48||)||$||(6.81||)||$||(4.69||)|
|Weighted-average shares outstanding—basic and diluted||18,666||13,423||18,616||11,284|
Consolidated Balance Sheets
|Cash and cash equivalents||$||55,430||$||108,927|
|Accounts receivable, net||22,191||9,339|
|Insurance proceeds receivable||—||22,000|
|Prepaid expenses and other current assets||11,183||9,762|
|Property and equipment, net||2,920||4,159|
|Intangible assets, net||225,272||250,324|
|Accounts payable and accrued liabilities||$||55,638||$||54,789|
|Provision for legal settlement||39,612||64,010|
|Convertible notes, net||258,538||225,584|
|Total stockholders' equity||14,938||135,787|
|Total liabilities and stockholders' equity||$||369,322||$||480,782|
Reconciliation of GAAP to Non-GAAP Financial Information
(in thousands, except per share amounts)
|Three Months Ended ||Year Ended |
|Net loss reconciliation:|
|GAAP net loss||$||(24,568||)||$||(19,920||)||$||(126,710||)||$||(52,870||)|
|Amortization of acquired intangible assets||6,274||2,134||25,052||2,134|
|Amortization of debt discount||8,750||3,253||32,954||3,253|
|Inventory fair value step-up||5,113||677||31,613||677|
|2016 Aegerion non-GAAP net loss (Note 1)||—||(6,830||)||—||(90,024||)|
|Restructuring charge related to acquisition||(4||)||180||2,536||180|
|Non-GAAP net loss||$||(3,317||)||$||(20,094||)||$||(30,018||)||$||(135,985||)|
|GAAP net loss per common share - basic and diluted||$||(1.32||)||$||(1.48||)||$||(6.81||)||$||(4.69||)|
|Non-GAAP net loss per common share - basic||$||(0.18||)||$||(1.50||)||$||(1.61||)||$||(12.05||)|
|GAAP and Non-GAAP weighted-average common shares outstanding — basic||18,666||13,423||18,616||11,284|
|Net revenues reconciliation:|
|GAAP net revenues||$||38,908||$||13,574||$||138,438||$||13,574|
|2016 Aegerion revenues (Note 1)||—||24,038||—||139,671|
|Non-GAAP net revenues||$||38,908||$||37,612||$||138,438||$||153,245|
|Cost of product sales reconciliation:|
|GAAP cost of product sales||$||16,993||$||5,971||$||77,220||$||5,971|
|Amortization of acquired intangible assets||(6,274||)||(2,134||)||(25,052||)||(2,134||)|
|Inventory fair value step-up||(4,390||)||(677||)||(29,585||)||(677||)|
|Aegerion non-GAAP cost of product sales (Note 1)||—||(116||)||—||33,417|
|Non-GAAP cost of product sales||$||6,329||$||3,044||$||22,583||$||36,577|
|Selling, general and administrative reconciliation:|
|GAAP selling, general and administrative||$||24,111||$||15,953||$||96,472||$||29,525|
|Inventory fair value step-up||(723||)||—||(2,028||)||—|
|Aegerion non-GAAP SG&A (Note 1)||—||40,316||—||171,114|
|Non-GAAP selling, general and administrative||$||22,481||$||55,887||$||90,723||$||200,098|
|Research and development reconciliation:|
|GAAP research and development||$||11,772||$||6,010||$||49,008||$||14,784|
|Aegerion non-GAAP R&D (Note 1)||—||8,244||—||37,417|
|Non-GAAP research and development||$||11,561||$||14,224||$||48,192||$||52,077|
Note 1 - Includes financial information from pre-merger Aegerion for the two and eleven months ended
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