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Vanda-Pharmaceuticals Reports Fourth-Quarter 2014 and Full-Year 2014 Financial-Results
Last update: 19/02/2015 7:00:18 am
Vanda Pharmaceuticals Reports Fourth Quarter 2014 and Full Year 2014 Financial Results
- HETLIOZ(R) net product sales in the U.S. grew to $6.0 million in the fourth quarter of 2014, a 15% increase as compared to the third quarter of 2014.
- Vanda expects HETLIOZ(R) net product sales for 2015 to grow to between $40 and $45 million.
- Combined 2015 net product sales from both HETLIOZ(R) and Fanapt(R) are expected to be between $95 million and $110 million.
PR Newswire
WASHINGTON, Feb. 19, 2015
WASHINGTON, Feb. 19, 2015 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational results for the fourth quarter and full year ended December 31, 2014.
"2014 was a transformational year for Vanda with the HETLIOZ launch in the U.S. for the treatment of Non-24-Hour Sleep-Wake Disorder. We are impressed with the continued growth of HETLIOZ and are fortunate to be able to offer this important treatment option for patients" said Mihael H. Polymeropoulos M.D., Vanda's President and CEO. "The return of the U.S. and Canadian commercial rights to Fanapt brings an immediately accretive product to Vanda further strengthening our U.S. commercial portfolio."
Key Highlights:
HETLIOZ(R) (tasimelteon) -- HETLIOZ(R) net product sales in the U.S. grew to $6.0 million in the fourth quarter of 2014, a 15% increase, compared to $5.2 million in the third quarter of 2014. HETLIOZ(R) net product sales were $12.8 million for the full year 2014.
-- Since the U.S. commercial launch of HETLIOZ(R) in April 2014, over 760 new patient prescriptions have been written including over 220 in the fourth quarter of 2014. As of December 31, 2014, over 470 patients had initiated HETLIOZ(R) treatment and over 330 patients were on active treatment reflecting a cumulative persistence rate of approximately 70%.
-- The HETLIOZ(R) Marketing Authorization Application in the European Union (EU) is under review with a regulatory decision expected in the third quarter of 2015.
-- Tasimelteon life cycle management activities are ongoing and include a Smith-Magenis Syndrome observational study with results expected in the first half of 2015 and preparations for a clinical development program for pediatric Non-24.
-- HETLIOZ(R) exclusivity in the U.S. is protected by orphan exclusivity and two patents listed in the FDA Orange Book (Orphan exclusivity expiry in 2021; Patent No. 5,856,529 expiry expected in 2022 and Patent No. 8,785,492 expiry in 2033).
Fanapt(R) (iloperidone) -- Fanapt(R) royalty revenue was $1.6 million for the fourth quarter of 2014, compared to $1.7 million in the third quarter of 2014. Fanapt(R) royalty revenue was $6.5 million for the full year 2014, compared to $7.1 million for 2013.
-- For the full year 2014, Fanapt(R) U.S. net product sales were $65.0 million, as reported by Novartis AG (Novartis). Fanapt(R) U.S. prescriptions for the fourth quarter of 2014 were approximately 40,500, as reported by IMS.
-- On December 31, 2014, the Fanapt(R) U.S. and Canadian rights were returned to Vanda as part of the settlement of arbitration with Novartis.
-- Fanapt(R) exclusivity in the U.S. is protected by two patents listed in the FDA Orange Book (Patent No. RE39198 expiry in 2016 and Patent No. 8,586,610 expiry in 2027).
VLY-686 (tradipitant) -- Results of the Phase II study (2101) of tradipitant, an NK1 receptor antagonist, in patients with chronic pruritus are expected in the first quarter of 2015.
Financial Results for the Fourth Quarter and Full Year 2014
Vanda total revenues for the fourth quarter of 2014 were $15.4 million, compared to $8.8 million for the fourth quarter of 2013. Vanda total revenues for the full year 2014 were $50.2 million, compared to $33.9 million for 2013.
Selling, general and administrative expenses were $17.3 million in the fourth quarter of 2014, compared to $9.9 million in the fourth quarter of 2013. Selling, general and administrative expenses were $84.6 million in the full year 2014, compared to $25.1 million in 2013. The increases in selling, general and administrative expenses in fourth quarter and full year 2014 were the result of the U.S. commercial launch support for HETLIOZ(R) .
Research and development expenses were $4.8 million in the fourth quarter of 2014, compared to $6.3 million in the fourth quarter of 2013. Research and development expenses were $19.2 million in the full year 2014, compared to $28.5 million in 2013.
Vanda recorded a $77.6 million gain related to the Novartis arbitration settlement in the fourth quarter of 2014.
Vanda net income was $69.7 million for the fourth quarter of 2014, compared to a net loss of $7.7 million for the fourth quarter of 2013. Diluted net income per share for the fourth quarter of 2014 was $1.77, compared to a net loss per share of $0.23 for the fourth quarter of 2013. Vanda net income was $20.2 million for the full year 2014, compared to a net loss of $21.1 million for 2013. Diluted net income per share for the full year 2014 was $0.55, compared to a net loss per share of $0.69 for 2013.
In October 2014, Vanda completed a public common stock offering that resulted in $62.3 million in net proceeds. In December 2014, Vanda sold $25.0 million of common stock to Novartis as part of the arbitration settlement. Cash, cash equivalents and marketable securities were $129.8 million as of December 31, 2014.
Non-GAAP Financial Results
Vanda Non-GAAP Total revenues for the fourth quarter of 2014 were $7.6 million, compared to $2.0 million for the fourth quarter of 2013. Vanda Non-GAAP Total revenues for the full year 2014 were $19.4 million, compared to $7.1 million for 2013.
Vanda Non-GAAP Net loss was $13.5 million for the fourth quarter of 2014, compared to a net loss of $12.7 million for the fourth quarter of 2013. Non-GAAP Diluted net loss per share for the fourth quarter of 2014 was $0.36, compared to a net loss per share of $0.38 for the fourth quarter of 2013. Vanda Non-GAAP net loss was $80.0 million for the full year 2014, compared to a net loss of $40.9 million for 2013. Non-GAAP Diluted net loss per share for the full year 2014 was $2.30, compared to a net loss per share of $1.35 for 2013.
Vanda provides Non-GAAP financial information, which it believe can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information.
2015 Financial Guidance
Vanda expects to achieve the following financial objectives in 2015: -- Combined net product sales from both HETLIOZ(R) and Fanapt(R) of between $95 million and $110 million.
-- HETLIOZ(R) net product sales of between $40 million to $45 million and Fanapt(R) net product sales of between $55 million to $65 million.
-- Non-GAAP Operating expenses, excluding cost of sales, of between $105 million and $120 million.
In addition, for reporting periods beginning in 2015, Vanda will no longer record Fanapt(R) licensing agreement revenues and will no longer report the number of HETLIOZ(R) prescriptions written, dispensed or patients on therapy.
Full HETLIOZ(R) Prescribing Information can be found at: www.hetlioz.com.
Full Fanapt(R) Prescribing Information, including Boxed Warnings and Important Safety Information can be found at: www.fanapt.com.
Conference Call
Vanda has scheduled a conference call for today, Thursday, February 19, 2015, at 10:00 AM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2014 financial results and other corporate activities. Investors can call 1-800-708-4540 (domestic) or 1-847-619-6397 (international) and use passcode 38933858. A replay of the call will be available beginning Thursday, February 19, 2015 at 12:30 PM ET and will be accessible until Thursday, February 26, 2015, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The passcode number is 38933858.
The conference call will be broadcast simultaneously on Vanda's website, www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days.
Non-GAAP Financial Information
Vanda believes that the Non-GAAP financial information provided in this release can assist investors in understanding and assessing the ongoing economics of the Company's business and reflect how it manages the business internally and sets operational goals. Vanda's "Non-GAAP revenues" excludes the Fanapt(R) licensing agreement revenue. The Company's "Non-GAAP G&A expenses" and "Non-GAAP R&D expenses" exclude stock based compensation. "Non-GAAP net income (loss)" and "Non-GAAP Diluted net income (loss) per share" excludes the Fanapt(R) licensing agreement revenue, stock based compensation, intangible asset amortization and gain on arbitration settlement.
Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of its business and the Company's use of financial resources and the Company's long-term performance.
This press release includes Non-GAAP Operating expenses, a forward-looking Non-GAAP financial measures under the heading "2015 Financial Guidance". This Non-GAAP financial measures was determined by excluding cost of sales, stock based compensation and intangibile asset amortization. We are unable to reconcile this Non-GAAP guidance to GAAP because it is difficult to predict the future impact of these adjustment.
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A total of 22.41 million shares more ( DILUTION)
Average Purchase $ 331,910,000
Average total purchase: $14.81
Now you understand, why they want that you buy?
Besides dilution want to steal. Less
Now I understand analysts TDA ResearchTeamTM Sell TheStreet:Sell S&P Capital IQ:No rating Ford Equity Research: Strong Sell MarketEdge:No rating Jaywalk Consensus:Sell
Our system’s recommendation today is to SELL. The BEARISH ONE BLACK CROW pattern finally received a confirmation because the prices crossed the confirmation level which was at 14,5800, and our valid average selling price stands now at 14,5000. The previous BUY recommendation was issued on 22/05/2014, 22 days ago, when the stock price was 9,9600. Since then VNDA has risen by +45,58%.
Market Outlook
We may be at a market top or at the start of a correction. The market ran out of steam and the traders are now more in agreement about the bearishness. The evidence is strong enough to prompt the closing of long positions. Today’s candlestick has a black body and its close is below the confirmation level. The bearish pattern that was previously identified is finally confirmed and a SELL signal is generated. You still have time to follow the signal and then you may start checking other securities for a bullish bet. Less
ZACKS:Ariad Pharmaceuticals had the Lowest Relative Performance in the Biotechnology Industry (ARIA, MNKD, BCRX, INSM, VNDA)
Jun 13, 2014 (Fast Lane via COMTEX) -- Below are five companies in the Biotechnology industry that underperformed yesterday on a relative basis. This analysis was compiled based on yesterday's trading activity as we search for stocks that have could possible underperform its peers going forward.
Ariad Pharmaceuticals (NASDAQ:ARIA) ranks first with a loss of 8.69%; MannKind (NASDAQ:MNKD) ranks second with a loss of 5.51%; and BioCryst Pharmaceuticals (NASDAQ:BCRX) ranks third with a loss of 3.07%.
Insmed (NASDAQ:INSM) follows with a loss of 2.79% and Vanda Pharmaceuticals (NASDAQ:VNDA) rounds out the bottom five with a loss of 2.54%.ARIAD Pharmaceuticals, Inc. discovers and develops breakthrough medicines that regulate cell signaling with small molecules. The Company is primarily focused on product candidates for targeted indications. ARIAD is developing products to treat solid tumors, to block the spread of cancer, to treat certain forms of leukemia, and to treat cancer that has spread to bone and primary bone cancers. Less
VNDA is rated BUY, based on 3 Wall Street analysts' reports. Analysts have an average $21.33 Target Price on VNDA, implying 78.8% Upside to its current price of $11.93.
They will push this down as far as they can. I'm sure many bought above $13 and $14 and are now stuck holding the bag. But this would be a good entry point for when more news does pop like you say.
Wait and see....patience. The CC could mention something that would be good for another 10% pop. Tea leaves about pricing of product or any number of factors could drive this one either direction pretty quickly. Be ready and nimble....the pop (if at all) would likely be short lived. Seems conformation bias plagues this one.
News already priced in it seems. I've seen this a few times where a stock drops on news as opposed to sky rocketing. I think it will pull back a bit more as people jump ship.
I'm currently in March $11 puts and March $15 Calls (average .90ish on both sides) Also added Feb $10 Puts and Feb $14 Calls slowly throughout the last two weeks.
I added puts on the runs and calls on the dips so my premiums are nice and low. I tend to be patient and methodical when adding, and always 1:1.
Either way, I don't expect an explosive run on VNDA (hence March options for slow run)...but I hope for it (hence Feb options).
CHTP on the other hand, I expect to lock in large profits very quickly in either direction (assuming no delay) as she has proved a beast with news.
So looks like they are planning for an approval? I just don't see how much upside there will be upon approval. New 52 week high? I know it's undervalued for sure.
Item 1.01. Entry into a Material Definitive Agreement.
On January 24, 2014, Vanda Pharmaceuticals Inc. (“Vanda” or the “Company”) and Patheon Pharmaceuticals Inc. (“Patheon”) entered into a Manufacturing Agreement (the “Agreement”) for the manufacture of commercial supplies of HETLIOZTM 20 mg capsules (tasimelteon capsules) at Patheon’s Cincinnati, Ohio manufacturing site. Under the Agreement, the Company is responsible for supplying the active pharmaceutical ingredient for HETLIOZTM to Patheon and has agreed to certain minimum yearly order requirements. Patheon is responsible for manufacturing the HETLIOZTM 20 mg capsules, conducting quality control and stability testing, and packaging the HETLIOZTM capsules.
The Agreement has an initial term of five years and will automatically renew after the initial term for successive terms of one year each, unless either party gives notice of its intention to terminate the Agreement at least twelve months prior to the end of the then current term. Either party may terminate the Agreement under certain circumstances upon specified written notice to the other party.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by the full text of the Agreement, a copy of which will be filed with the exhibits to Vanda’s quarterly report on Form 10-Q for the quarter ending March 31, 2014.
Vanda is developing important new medicines to improve the lives of patients. We use new technologies, including genetics and genomics, to inform our drug discovery, our clinical trials, and our commercial positioning of our compounds. We are working to advance the science of developing new medicines and to use novel approaches to deliver these new medicines to patients. Our CEO, Mihael Polymeropoulos, MD, founded Vanda in 2003. Previously, he founded and ran the Novartis global Pharmacogenetics department, one of the industry leaders. Prior to that he worked for many years at the National Institute of Mental Health and the National Human Genome Research Institute, where he did pioneering work in gene mapping. He founded Vanda in partnership with Care Capital LLC, the prominent biopharmaceuticals-focused investment firm, and Bio*One Capital, an investment arm of the Singapore government with a focus on new biomedical enterprises. Vanda has assembled an experienced team and a stable of clinical stage compounds to deliver on its vision.
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