The biotech sector has been full of consolidation and mergers of late, but now we have a new model whereby a smaller company is set to grow by taking a part of a larger company. We cannot exactly call it a reverse merger. Alkermes, Inc. (NASDAQ: ALKS) and Elan Corporation, plc (NYSE: ELN) have signed a definitive pact where Alkermes will merge with Elan’s unit called Elan Drug Technologies.
The drug technologies unit is profitable and is the drug formulation and manufacturing unit. The cash and stock transaction is valued toda at roughly $960 million and Alkermes and the unit will be combined under a new holding company structure that is incorporated in Ireland called Alkermes plc.
Alkermes says this deal will be immediately accretive to cash earnings. It also is said to accelerate Alkermes’ path “to building a sustainably profitable biopharmaceutical company with expertise in developing treatments for central nervous system diseases and a broad, diversified portfolio of products and pipeline based on proprietary science and technologies.”
The deal is a game-changer because on a standalone basis Alkermes was set to have a loss of -$0.31 EPS on $213.27 million in its fiscal year March-2012. The combined company is said to see a growing product, royalty and manufacturing revenues in excess of $450 million annually. Alkermes said it will also become immediately profitable on a cash earnings basis. In short, Alkermes instantly transforms. Now the company will have a revenue stream from 25 commercialized products and its 5 growth products will now be from RISPERDAL CONSTA, INVEGA SUSTENNA, AMPYRA, VIVITROL, and BYDUREON.
For Elan, it gets to cut the debt on its balance sheet and will get to improve its capital structure, increase its operating leverage, and this will allow for additional focus and disciplined investments. It also gets a stake in Alkermes plc that can drive its value ahead.
RISPERDAL CONSTA and INVEGA SUSTENNA are both commercialized by Johnson & Johnson (NYSE: JNJ) as long-acting injectable atypical antipsychotic medications for schizophrenia and bipolar I disorder. Ampyra is an MS drug under Acorda Therapeutics, Inc. (NASDAQ: ACOR). Bydureon is an extended release Typy-II diabetes treatment that Alkermes is in with Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) and Eli Lilly and Company (NYSE LLY).
Elan is set to receive $500 million plus it will also receive 31.9 million ordinary shares of Alkermes plc common stock. The companies will also enter into a shareholder agreement that contains a lockup, standstill and voting agreement for Elan’s shares of Alkermes plc.
As far as existing Alkermes holders, they will receive one ordinary share of Alkermes plc per each share of Alkermes, Inc. owned at the merger date. The new Alkermes plc shares will be registered in the United States and are expected to trade on NASDAQ. Alkermes plc will be headquartered in Dublin, Ireland The company did note that this transaction is expected to be taxable to existing Alkermes holders and it has obtained a commitment from Morgan Stanley & Co. and HSBC to provide up to $450 million of term loans to finance the transaction.
Revenues are expected to grow in fiscal 2012 and is expected to reach double-digit growth rates in fiscal 2013 and beyond. Pro forma Adjusted EBITDA margins in fiscal 2012 are projected at 15% to 20%, pro forma Adjusted EBITDA is put at $70 million to $90 million, and pro forma adjusted EBITDA margins should expand to 30% to 35% in fiscal year 2013 and beyond. Also noted was that it has identified about $20 million of annual synergies in U.S. operations that can be fully realized by fiscal 2013.
JON C. OGG
Biotech earnings are seeing mixed reactions after the news so far. Biogen Idec Inc. (NASDAQ: BIIB) has some very positive momentum behind it that may be changing how investors view the company. The company was noted as a win by Zacks Investment Research this morning with references to Elan Corp. (NYSE: ELN) and Novartis (NYSE: NVS). What is perhaps most interesting about Biogen Idec is that the stock is hitting 52-week highs today and the new 52-week trading range is $41.75 to $61.57. If you go back further, Biogen is actually trading at a high not seen since the big slide in mid-2008. Some investors and traders may now be hoping that today’s move represents a full breakout from a very long trading range.
Zacks noted Biogen Idec as “Biogen Beats by a Wide Margin” and is as follows:
Biogen Idec Inc. (NASDAQ: BIIB) reported third-quarter earnings per share of $1.33, well above the Zacks Consensus Estimate of $1.20 and the year-earlier figure of $1.09. Excluding the impact of stock-based compensation expense, third quarter 2010 earnings came in at $1.35 per share. Performance was boosted by higher revenues and lower share count. Revenues increased 5% to $1.18 billion, with Tysabri and Rituxan being the primary growth drivers. Revenues were slightly above the Zacks Consensus Estimate of $1.16 billion.
Revenue by Major Products
Third quarter Tysabri revenues came in at $221 million, up 7% from the prior period. Global in-market net sales of Tysabri, which is partnered with Elan Corp. (NYSE: ELN), came in at $307 million (up 9%) in the third quarter of 2010. Tysabri global sales consisted of US sales of $151 million and ROW (Rest of the World) sales of $156 million.
Biogen estimates that as of the end of Sept. 2010, about 55,100 patients were on commercial and clinical Tysabri therapy worldwide. This represents an increase from the 52,700 patients reported by the company in the second quarter of 2010.
With Tysabri being an important growth driver for Biogen, we remain concerned that an increase in the number of progressive multifocal leukoencephalopathy (PML) cases associated with its use could lead to a slowdown in Tysabri sales going forward. We note that new patient additions during the third quarter remained flat sequentially at 2,400.
Biogen is currently conducting studies (STRATIFY 1 and STRATIFY 2) to confirm that patients who test negative on the JC virus assay could use Tysabri with lower concerns regarding the development of PML. Biogen reported that Elan presented data supporting the utility of using a JC virus assay. The companies intend to apply for label changes in both the US and the EU by the first quarter of 2011.
Meanwhile, Biogen’s lead multiple sclerosis (MS) product Avonex posted second quarter sales of $644 million (up 11%).
We note that, going forward, both Avonex and Tysabri will face additional competition in the form of Novartis’ (NYSE: NVS) Gilenya which was launched in early Oct. Results from a study comparing Gilenya with Avonex showed that Gilenya reduced relapse rates by 52% at one year compared with Avonex. Being an oral therapy, Gilenya could find quick acceptance as currently available therapies require injection or infusion.
Meanwhile, we were disappointed to see Rituxan revenues decline 9% to $258 million in the third quarter. Biogen and partner Roche have been working on driving Rituxan growth by expanding the label for additional indications. Moreover, Biogen has been working on improving unit and market share performance of the product through greater sales efforts, improving customer segmentation and highlighting the data on the product.
This morning we have seen an unusual number of analyst upgrades and downgrades in the drug and biotech space that comprises BioHealth. These are the top analyst upgrades, downgrades, and initiations in the BioHealth sector this Thursday morning:
- BioMarin (NASDAQ: BMRN) Raised to Outperform at Credit Suisse.
- Cubist Pharmaceuticals (NASDAQ: CBST) Raised to Perform at Oppenheimer.
- Cytokinetics (NASDAQ: CYTK) Cut to Hold at Needham.
- Elan Corp. plc (NYSE: ELN) Cut to Neutral at UBS.
- Pharmaceutical Product Development (NASDAQ: PPDI) Cut to Market Perform at Wells Fargo.
- Repligen (NASDAQ: RGEN) Cut to Sector Perform at RBC Capital.
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JON C. OGG
Biogen Idec Inc. (NASDAQ: BIIB) is feeling the pain of regulatory review this morning. And Elan Corp. plc (NYSE: ELN) is feeling it even worse. The reason these are under pressure this Friday is because a European panel has begun a review of Biogen’s controversial yet effect multiple sclerosis drug TYSABRI. The review is over higher rates of PML brain infections (progressive multifocal leukoencephalopathy) than had been disclosed.
The European Medicines Agency’s Committee for Medicinal Products for Human Use showed some 23 PML cases since the launch of TYSABRI. Previous data showed that there were 13 cases since TYSABRI came back on the market in 2006 after the company voluntarily removed it to study the PML data. The European panel will discuss additional measures, if needed, to ensure a safe use of the drug and how to measure risks.
Biogen Idec is already in U.S. talks with the FDA over the TYSABRI label. Most recent data showed more than 46,000 people were taking TYSABRI, and over 13,000 patients had been taking TYSABRI for more than two years and were classified under long-term use.
It is impossible to pre-judge this situation, but personal discussions have given a personal belief here that the reason people keep taking TYSABRI is because many think it is the best MS drug on the market. As far as a 1 in a thousand risk, that is a very low incident ratio compared to other drugs that treat other diseases and many are willing to take that risk.
Biogen Idec is down 5.7% at $44.50 and Elan is down almost 17% at $5.35. Acorda Therapeutics, Inc. (NASDAQ: ACOR) has been noted this week as having an MS drug candidate pending under priority review date and that has been extended out to January 2010 by the FDA.
JON C. OGG
OCTOBER 23, 2009
BioHealth Earnings Floodgates Opening (BSX, BIIB, GILD, ISRG, PFE, DGX, SYK, AMGN, ELN, LLY, GENZ, STJ, BMY, MRK, SGP, ZMH)
Next week is going to be the mother of all earnings reports for the BioHealth community. We have included the key device companies as well in this calendar with the routine top drug and biotech companies. As a reminder, these estimates may change between now and when some of the players report earnings. In the screens for earnings we have the estimates included listed as the Thomson Reuters consensus figures.
MONDAY OCTOBER 19
- Boston Scientific Corporation (NYSE: BSX) $0.14 EPS on $2.04 billion in revenues
TUESDAY OCTOBER 20
- Biogen Idec Inc. (NASDAQ: BIIB) $1.04 EPS on $1.11 billion in revenues
- Gilead Sciences Inc. (NASDAQ: GILD) $0.67 EPS on $1.76 billion in revenues
- Intuitive Surgical, Inc. (NASDAQ: ISRG) $1.46 EPS and $256.44 million in revenues
- Pfizer Inc. (NYSE: PFE) $0.48 EPS and $11.4 billion in revenues
- Quest Diagnostics Inc. (NYSE: DGX) $0.96 EPS and $1.89 billion in revenues
- Stryker Corp. (NYSE: SYK) $0.69 EPS and $$1.62 billion in revenues
WEDNESDAY, OCTOBER 21
- Amgen Inc. (NASDAQ: AMGN) $1.27 EPS and $3.79 billion in revenues
- Elan Corporation, plc (NYSE: ELN) -$0.13 EPS on $285.18 million in revenues
- Eli Lilly & Co. (NYSE: LLY) $1.01 EPS and $5.4 billion in revenues
- Genzyme Corporation (NASDAQ: GENZ) $0.44 EPS and $1.11 billion in revenues
- St. Jude Medical, Inc. (NYSE: STJ) $0.58 EPS and $1.16 billion in revenues
THURSDAY, OCTOBER 22
- Bristol-Myers Squibb (NYSE: BMY) $0.51 EPS and $5.5 billion in revenues
- Merck & Co., Inc. (NYSE: MRK) $0.83 EPS and $6 billion in revenues
- Schering-Plough Corporation (NYSE: SGP) $0.39 EPS and $4.45 billion in revenues
- Zimmer Holdings Inc. (NYSE: ZMH) $0.86 EPS and $953.6 million in revenues
JON C. OGG
OCTOBER 16, 2009
Biogen Idec (NASDAQ: BIIB) has been having issues with its MS franchise TYSABRI for what is becoming a multi-year event. It already has a blockbuster with its AVONEX for RMS. But the stock is enjoying a second day of gains today after its “other” Multiple Sclerosis treatment has received an FDA Fast Track Designation. The announcement was made on Wednesday that its PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) received the designation.
Our take has long been that TYSABRI has been given a bit of a bad wrap because of the PML cases. It isn’t that this is not an issue. Having spoken with multiple TYSABRI users and family members of theirs over the years, it is our opinion that most users feel that TYSABRI is worth the risk as the PML cases are so isolated. But it would be foolish to not acknowledge that this has significantly lowered the number of TYSABRI ‘clients.’
After looking through the data, it seems that there is a chance that this PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis could end up being a significant game changer for the company. With a risk, of course. Elan Corp. plc (NYSE: ELN) is the TYSABRI partner, and while recent developments may help Elan it has spent its time in and out of being considered a “troubled stock” for longer than memory would serve.
Today we are seeing pretty thin coverage from analysts regarding biotech, drug, and healthcare stocks. These are the few we are seeing with over 90 minutes to to go before the market opens:
- Elan (ELN) Raised to Equal-weight at Lehman.
- Health Net (HNT) Cut to Hold at Citigroup.
- Novartis (NVS) Cut to Neutral at JPMorgan.
Jon C. Ogg
August 6, 2008
Today was the long awaited Alzheimer’s drug data presented from Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE). The companies presented detailed results from their 18-month Phase II study of bapineuzumab in patients with mild to moderate Alzheimer’s disease.
The study was on 234 randomized with findings reported on 229 patients, and efficacy was measured from a baseline of 78 weeks. The data looked very positive on the surface with safety and efficacy results supporting the design of an ongoing global Phase III program.
Some data is mixed and shares were hit as a result. It showed statistically significant and clinically meaningful effects were observed in multiple endpoints in ApoE4 non-carriers. The company also noted that pre-specified efficacy analysis did not reach significance in the total population.
Favorable directional changes were seen in some endpoints in ApoE4 carriers, warranting further study. The post-hoc anlysis showed statistically significant and clinically meaningful benefits in important subgroups.
You can read about the full results here. There were measurements of less or slower brain shrinkage combined with better memory test results observed in the study, and if our data is correct that would be superior to any existing treatments and is probably above other study reports to date.
The problem is the pre-specified efficacy analysis as well as a few deaths in the trial (which were noted as “unbelieved to be from the drug” despite no deaths in teh placebo group.
This data was shown at the Alzheimer’s Association’s International Conference on Alzheimer’s Disease 2008 in Chicago, Illinois.
Shares are getting slapped down in after-hours. Wyeth stock is down 8.5% at $41.25 and Elan stock is down 15% at $28.49 in after-hours trading. Both stocks had been higher initially ahead of the data. This looks more and more like mixed data, and unfortunately it looks like Alzheimer’s patients have a long way to go before even any meaningful help will arrive.
Jon C. Ogg
July 29, 2008 (5:45 PM EST)