Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - AVANIR PHARMACEUTICALS, INC. | d640783d8k.htm |
| EX-1.1 - EX-1.1 - AVANIR PHARMACEUTICALS, INC. | d640783dex11.htm |
| EX-5.1 - EX-5.1 - AVANIR PHARMACEUTICALS, INC. | d640783dex51.htm |
Exhibit 99.1
Avanir Pharmaceuticals Reports Fiscal 2013 Fourth Quarter Financial and
Year-End Business Results
ALISO VIEJO, Calif., December 10, 2013—Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported financial results for the three and twelve-months ended September 30, 2013.
Quarterly Financial Highlights
| • | Total company net revenues of $21.7 million |
| • | Gross and net NUEDEXTA® sales increased to $27.7 million and $20.2 million respectively |
| • | Cash, cash equivalents, and restricted investments of $57.5 million as of September 30, 2013 |
“2013 has been a break-out year for Avanir,” said Keith A. Katkin, president and CEO of Avanir. “We have achieved a number of important and transformational milestones. In addition to robust growth of NUEDEXTA for PBA we formed a co-promote partnership with Merck which will leverage our commercial leadership in the institutional setting. We also in-licensed a new investigational migraine treatment, gained European approval for NUEDEXTA and initiated a new phase II study of AVP-923 exploring its potential application in levadopa-induced dyskinesias in Parkinson’s disease.
Fiscal 2013 Fourth Quarter Results
| • | Total net revenues for the quarter ended September 30, 2013 were $21.7 million, compared with $13.5 million for the comparable quarter in fiscal 2012, representing approximately 61% year-over-year growth. Total net revenues consist of NUEDEXTA net revenue and royalty revenue from Abreva®. |
| • | Total operating expenses were $36.2 million in the fourth quarter of fiscal 2013, excluding a one-time payment of $20.0 million related to AVP-825, compared with $24.2 million in the comparable period in fiscal 2012. |
| • | Cash used in operations was $10.1 million, excluding a one-time payment of $20.0 million related to AVP-825. |
| • | Net loss for the quarter ended September 30, 2013 was $15.4 million, or $0.10 per share, excluding a one-time payment of $20.0 million related to AVP-825, compared with a net loss of $11.7 million, or $0.09 per share, for the same period in fiscal 2012. |
Fiscal 2013 Twelve-Month Results
| • | Total net revenues for fiscal 2013 were $75.4 million, compared with $41.3 million for fiscal 2012, representing 83% year-over-year growth. |
| • | Total operating expenses for fiscal 2013 were $126.8 million, excluding a one-time payment of $20.0 million related to AVP-825, compared to $99.7 million for fiscal 2012. |
| • | Cash used in operations for fiscal 2013 was $45.4 million, excluding the one-time payment of $20.0 million related to AVP-825. |
| • | Net loss for fiscal 2013 was $55.5 million, or $0.39 per share, excluding a one-time payment of $20.0 million related to AVP-825, compared with a net loss of $59.7 million, or $0.45 per share for fiscal 2012. |
Cash, Cash Equivalents & Marketable Securities
As of September 30, 2013 Avanir had cash, cash equivalents and restricted investments totaling $57.5 million, including cash and cash equivalents of $55.3 million.
Quarter and Recent Business Highlights
| • | Achieved 12% unit growth of NUEDEXTA representing the tenth consecutive quarter of double-digit growth. |
| • | Entered into an exclusive North American license agreement with Optinose AS, for the development and commercialization of a novel Breath Powered™ intranasal delivery system containing low-dose sumatriptan powder to treat acute migraine. If approved, this product would be the first and only fast-acting, dry-powder nasal delivery form of sumatriptan. |
| • | Entered into a multi-year agreement with Merck, known as MSD outside the United States and Canada, to co-promote Merck’s type 2 diabetes therapies JANUVIA® (sitagliptin) and the sitagliptin family of products in the long-term care institutional setting in the United States. |
| • | Enrolled the first patient in study AVR-133. The study is a proof of concept, Phase II clinical trial investigating the use of AVP-923 for the treatment of levodopa induced dyskinesia (LID) in patients with Parkinson’s disease (PD). |
Note to Investors: As previously announced, Avanir will hold a conference call to discuss fiscal 2013 fourth quarter financial results today, December 10, 2013, beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing 1-800 901-5213 for domestic callers or +1-617 786-2962 for international callers, and entering passcode 80893873. Those interested in listening to the conference call live via the internet may do so by visiting http://ir.avanir.com.
Note Regarding Non-GAAP Financial Information
This press release contains unaudited financial information under both U.S. generally accepted accounting principles (GAAP) basis and Non-GAAP basis. This Non-GAAP financial measure excludes certain non-routine transaction expenses to reflect an additional way of viewing aspects of our operations that, when viewed with the GAAP results and the reconciliations to the corresponding GAAP financial measure, provide a more complete understanding of our financial information and the factors and trends affecting our business. However, these Non-GAAP measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measure calculated in accordance with GAAP. We use our Non-GAAP financial measures internally to better understand and evaluate our business, prepare annual budgets, and in measuring performance.
Non-GAAP financial measures contained in this press release reflects adjustments based on the following items:
| GAAP Reconciliation (in millions) | ||||
| Fiscal 2013 Fourth Quarter Results |
||||
| Total operating expenses (GAAP) |
$ | 56.2 | ||
| AVP-825 license payment |
(20.0 | ) | ||
|
|
|
|||
| Total operating expenses (Non-GAAP) |
$ | 36.2 | ||
|
|
|
|||
| Cash used in operations (GAAP) |
$ | 30.1 | ||
| AVP-825 license payment |
(20.0 | ) | ||
|
|
|
|||
| Cash used in operations (Non-GAAP) |
$ | 10.1 | ||
|
|
|
|||
| Net loss (GAAP) |
$ | 35.4 | ||
| AVP-825 license payment |
(20.0 | ) | ||
|
|
|
|||
| Net loss (Non-GAAP) |
$ | 15.4 | ||
|
|
|
|||
| Basic and diluted net loss per share (GAAP) |
$ | (0.24 | ) | |
| Less: Impact on net loss per share from |
||||
| AVP-825 license payment |
0.14 | |||
|
|
|
|||
| Basic and diluted net loss per share (Non-GAAP) |
$ | (0.10 | ) | |
|
|
|
|||
| GAAP Reconciliation (in millions) | ||||
| Fiscal 2013 Twelve-Month Results: |
||||
| Total operating expenses (GAAP) |
$ | 146.8 | ||
| AVP-825 license payment |
(20.0 | ) | ||
|
|
|
|||
| Total operating expenses (Non-GAAP) |
$ | 126.8 | ||
|
|
|
|||
| Cash used in operations (GAAP) |
$ | 65.4 | ||
| AVP-825 license payment |
(20.0 | ) | ||
|
|
|
|||
| Cash used in operations (Non-GAAP) |
$ | 45.4 | ||
|
|
|
|||
| Net loss (GAAP) |
$ | 75.5 | ||
| AVP-825 license payment |
(20.0 | ) | ||
|
|
|
|||
| Net loss (Non-GAAP) |
$ | 55.5 | ||
|
|
|
|||
| Basic and diluted net loss per share (GAAP) |
$ | (0.53 | ) | |
| Less: Impact on net loss per share from |
||||
| AVP-825 license payment |
0.14 | |||
|
|
|
|||
| Basic and diluted net loss per share (Non-GAAP) |
$ | (0.39 | ) | |
|
|
|
|||
About AVP-825
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel breath-powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.
About AVP-923
AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. Several dose strengths of AVP-923 are being studied in multiple ongoing clinical trials including agitation in Alzheimer’s disease, and levodopa-induced dyskinesia in Parkinson’s disease. AVP-923 at the 20/10 mg dose strength is approved by the FDA for the treatment of pseudobulbar affect (PBA) and marketed under the trade name NUEDEXTA® (see description below). AVP-923 is an investigational drug not approved by the FDA for any uses other than PBA.
About NUEDEXTA
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.
NUEDEXTA Important Safety Information
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.
Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer’s disease and other dementias.
NUEDEXTA and certain other medicines can interact, causing serious side effects. If you take certain drugs or have certain heart problems, NUEDEXTA may not be right for you.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness.
These are not all the risks from use of NUEDEXTA. Please refer to full Prescribing Information at www.NUEDEXTA.com.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
AVANIR® and NUEDEXTA® are trademarks or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.
©2013 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir’s plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Avanir’s operating performance and financial position, the market demand for and acceptance of Avanir’s products domestically and internationally, research, development and commercialization of new products domestically and internationally, obtaining additional indications, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company’s most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
Avanir Investor & Media Contact
Ian Clements, PhD
ir@avanir.com
+1 (949) 389-6700
Brewlife Media Contact
Nicole Foderaro
nfoderaro@brewlife.com
+1 (415) 946-1058
AVANIR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2013 |
September 30, 2012 |
|||||||
| (unaudited) | (audited) | |||||||
| ASSETS | ||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 55,259,073 | $ | 69,778,406 | ||||
| Restricted cash and cash equivalents |
965,986 | 652,913 | ||||||
| Trade receivables, net |
12,525,992 | 7,231,759 | ||||||
| Inventories, net |
710,179 | 415,475 | ||||||
| Prepaid expenses and other current assets |
2,382,410 | 2,434,590 | ||||||
| Restricted short-term investment |
— | 401,550 | ||||||
|
|
|
|
|
|||||
| Total current assets |
71,843,640 | 80,914,693 | ||||||
| Restricted long-term investments |
1,303,938 | 1,302,136 | ||||||
| Property and equipment, net |
1,592,791 | 1,808,594 | ||||||
| Non-current inventories, net |
784,186 | 908,364 | ||||||
| Other assets |
554,452 | 1,078,009 | ||||||
|
|
|
|
|
|||||
| TOTAL ASSETS |
$ | 76,079,007 | $ | 86,011,796 | ||||
|
|
|
|
|
|||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: |
||||||||
| Accounts payable, accrued expenses and other liabilities |
$ | 25,560,756 | $ | 15,598,666 | ||||
| Current portion of note payble |
7,942,945 | 2,162,263 | ||||||
| Current portion of deferred royalty revenues |
1,288,514 | 2,557,464 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
34,792,215 | 20,318,393 | ||||||
| Accrued expenses and other liabilities, net of current portion |
1,393,075 | 666,179 | ||||||
| Note Payable |
21,422,163 | 26,698,263 | ||||||
| Deferred royalty revenues, net of current portion |
— | 1,491,854 | ||||||
|
|
|
|
|
|||||
| Total liabilities |
57,607,453 | 49,174,689 | ||||||
|
|
|
|
|
|||||
| Total stockholders’ equity |
18,471,554 | 36,837,107 | ||||||
|
|
|
|
|
|||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ | 76,079,007 | $ | 86,011,796 | ||||
|
|
|
|
|
|||||
| Three Months Ended September 30, |
Twelve Months Ended September 30, |
|||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| REVENUES |
||||||||||||||||
| Net product sales |
$ | 20,233,418 | $ | 12,393,358 | $ | 70,692,027 | $ | 37,074,567 | ||||||||
| Revenues from royalties |
1,214,194 | 1,138,448 | 4,453,707 | 4,200,506 | ||||||||||||
| Revenue from research grant services |
205,150 | — | 220,150 | — | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total revenues |
21,652,762 | 13,531,806 | 75,365,884 | 41,275,073 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| OPERATING EXPENSES |
||||||||||||||||
| Cost of product sales |
1,153,012 | 712,546 | 4,002,303 | 2,120,221 | ||||||||||||
| Cost of research grant services |
68,943 | — | 147,431 | — | ||||||||||||
| Research and development |
27,930,126 | 6,095,161 | 49,506,199 | 23,066,037 | ||||||||||||
| Selling and marketing |
17,612,199 | 11,171,704 | 63,201,776 | 52,463,409 | ||||||||||||
| General and administrative |
9,386,173 | 6,228,000 | 29,934,875 | 22,027,587 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating expenses |
56,150,453 | 24,207,411 | 146,792,584 | 99,677,254 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss from operations |
(34,497,691 | ) | (10,675,605 | ) | (71,426,700 | ) | (58,402,181 | ) | ||||||||
| OTHER INCOME (EXPENSE) |
||||||||||||||||
| Interest income |
7,335 | 12,752 | 51,914 | 42,815 | ||||||||||||
| Interest expense |
(954,894 | ) | (1,059,244 | ) | (4,097,846 | ) | (1,385,342 | ) | ||||||||
| Other, net |
— | — | (31 | ) | 4,081 | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss before provision for income taxes |
(35,445,250 | ) | (11,722,097 | ) | (75,472,663 | ) | (59,740,627 | ) | ||||||||
| Provision for income taxes |
3,200 | 3,200 | 3,200 | 3,200 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss and comprehensive loss |
$ | (35,448,450 | ) | $ | (11,725,297 | ) | $ | (75,475,863 | ) | $ | (59,743,827 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic and diluted net loss per share |
$ | (0.24 | ) | $ | (0.09 | ) | $ | (0.53 | ) | $ | (0.45 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic and diluted weighted average number of common shares outstanding |
147,851,544 | 136,239,668 | 142,269,399 | 133,358,571 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Three Months Ended September 30, |
Twelve Months Ended September 30, |
|||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| REVENUES |
||||||||||||||||
| Gross product sales |
$ | 27,666,348 | $ | 15,431,249 | $ | 91,205,182 | $ | 45,107,989 | ||||||||
| Less: discounts and allowances |
7,432,930 | 3,037,891 | 20,513,155 | 8,033,422 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net product sales |
20,233,418 | 12,393,358 | 70,692,027 | 37,074,567 | ||||||||||||
| Revenues from royalties |
1,214,194 | 1,138,448 | 4,453,707 | 4,200,506 | ||||||||||||
| Revenue from research grant services |
205,150 | — | 220,150 | — | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total revenues |
21,652,762 | 13,531,806 | 75,365,884 | 41,275,073 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| GTN% |
26.9 | % | 19.7 | % | 22.5 | % | 17.8 | % | ||||||||
| OPERATING EXPENSES |
||||||||||||||||
| Cost of product sales |
1,153,012 | 712,546 | 4,002,303 | 2,120,221 | ||||||||||||
| Cost of research grant services |
68,943 | — | 147,431 | — | ||||||||||||
| Research and development |
27,930,126 | 6,095,161 | 49,506,199 | 23,066,037 | ||||||||||||
| Selling and marketing |
17,612,199 | 11,171,704 | 63,201,776 | 52,463,409 | ||||||||||||
| General and administrative |
9,386,173 | 6,228,000 | 29,934,875 | 22,027,587 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating expenses |
56,150,453 | 24,207,411 | 146,792,584 | 99,677,254 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss from operations |
(34,497,691 | ) | (10,675,605 | ) | (71,426,700 | ) | (58,402,181 | ) | ||||||||
| OTHER INCOME (EXPENSE) |
||||||||||||||||
| Interest income |
7,335 | 12,752 | 51,914 | 42,815 | ||||||||||||
| Interest expense |
(954,894 | ) | (1,059,244 | ) | (4,097,846 | ) | (1,385,342 | ) | ||||||||
| Other, net |
— | — | (31 | ) | 4,081 | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss and comprehensive loss |
$ | (35,445,250 | ) | $ | (11,722,097 | ) | $ | (75,472,663 | ) | $ | (59,740,627 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic and diluted net loss per share |
$ | (0.24 | ) | $ | (0.09 | ) | $ | (0.53 | ) | $ | (0.45 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic and diluted weighted average number of common shares outstanding |
147,851,544 | 136,239,668 | 142,269,399 | 133,358,571 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Three Months Ended September 30, |
Twelve Months Ended September 30, |
|||||||||||||||
| Additional Information |
2013 | 2012 | 2013 | 2012 | ||||||||||||
| Gross Profit - Nuedexta |
19,080,406 | 11,680,812 | 66,689,724 | 34,954,346 | ||||||||||||
| Gross Margin - Nuedexta |
94.3 | % | 94.3 | % | 94.3 | % | 94.3 | % | ||||||||
| GTN% Discount |
26.9 | % | 19.7 | % | 22.5 | % | 17.8 | % | ||||||||
| Share-Based Comp |
1,338,284 | 1,262,773 | 5,845,793 | 4,877,482 | ||||||||||||
| Cash Used in Operations |
30,147,322 | 12,098,041 | 65,422,227 | 57,656,620 | ||||||||||||