Friday, May 31, 2013

Financings of the Fortnight Battles the Bull Run

Since when did biotech’s epicenter move to Pamplona? The bull run has lasted quite a while now, after having gotten an extra goose, if you don’t mind mixing barnyard metaphors, around the time hepatitis C treatment developer Pharmasset became the $11 billion target of Gilead Sciences in November 2011.

Once they scraped their jaws off the floor, analysts decided the deal wasn’t really so shocking despite the price tag. We’ll soon find out how well it pays off for Gilead. The HIV leader has put the main compound it acquired in that deal, sofosbuvir, through a battery of Phase III tests and applied for a marketing license.     

One could argue that the acquisition has already paid dividends not just to Gilead but to nearly every other biotech company with a pulse. Since the deal was announced in November 2011 the two major biotech indices from NASDAQ (NBI) and the NYSE (BTK) are up 97% and 93%, respectively. That's vastly outstripped the tech-heavy  NASDAQ Index, which is up a tidy 35%. You could slice and dice the good times in other ways, too: In the last five years, the NBI is up 138% and the BTK 170%, compared to 37% for the Nasdaq writ large.

Or, microcosmically, you could point to this morning's Epizyme activity. The epigenetics company, which our In Vivo colleagues profiled a year ago, sold IPO shares at $15 each, raising $77 million, and the stock began trading this morning at $20. (As of this writing it's up to $21.02.) That's a lot of enthusiasm for a company in a cutting-edge area of biomedical R&D with just a few months of a Phase I trial as the sum of its clinical experience (and the drug in that trial, to boot, is partnered to Celgene).  

The majority of the gains have come in the past year and a half. Whichever cut of the steak you prefer, it’s been an unusually long run for the sector, which tends to see run-ups for six months, perhaps a year, then lose much of the ground it has gained. Much of the fervor is driven by large-cap biotechs: Since November 2011, Biogen Idec, Vertex Pharmaceuticals, Celgene, Gilead Sciences, and Amgen have all outperformed the biotech indices (Gilead by a ton, the rest by a few percentage points). As ISI Group analyst Mark Schoenebaum pointed out recently,  the NBI has soared (and even surpassed in March the high water mark that the genomics bubble left in March 2000), all while the median price-to-earnings ratio of large cap biotech has deflated like a forgotten balloon for years.

Many mid-cap biotechs are making hay, too. Onyx Pharmaceuticals is up 125%, Isis Pharmaceuticals 156%, Clovis 166%, Alnylam Pharmaceuticals 249% -- yeah, Alnylam, whose partners abandoned its RNAi platform a few years ago, and which made a sharp right turn as a slimmed-down clinical-stage company in 2010 – and speaking of rising from the ashes, Medivation, they of Dimebon infamy, are up 451%, all since November 2011.

There are others, and the list of billion-dollar market caps is getting a little heavy. We’re not saying that Sarepta Therapeutics, which has been grinding away at a novel approach to treating Duchenne’s muscular dystrophy for several years after shifts in focus, top management, and company name, is the life sciences equivalent to; or that Acadia Pharmaceuticals, a 20-year-old firm working toward approval of its Parkinson’s psychosis treatment, is this year’s Webvan. But talk of a bubble is, well, bubbling up, and one wonders if it will pop in the summer heat. It’s conventional wisdom that the down time after the annual American Society for Clinical Oncology (ASCO) conference, gearing up right now in Chicago, is also profit-taking time.

Until now, though, it’s been a seller’s market. To date, biotech follow-on sales have raised $4 billion this year. That’s nearly two-thirds of last year’s $6.5 billion total in just under five months, according to Elsevier’s Strategic Transactions database.

Put another way, there have been 18 follow-on sales of $75 million or more so far in 2013. That nearly equals last year’s total of 21. And it’s not just the high flyers raising barrels-full. As we describe below in our round-up, Ironwood Pharmaceuticals ginned up a cool $136 million by selling 10.5 million shares. Shares of the constipation-relief developer have appreciated only modestly while the male bovines have cavorted. Starting at the November 2011 "goose" mark, Ironwood has only risen 7%. Or, if you prefer a somewhat less arbitrary start date, Ironwood is up 23% since its February 2010 IPO, while the Nasdaq has risen 63% and the biotech indices have more than doubled.

So with the likes of Ironwood raising more than $200 million in equity and another $175 million in debt since the market’s gone nuts, we’re going to speculate that companies below the large-cap range are having little problem getting the cash they need. (In Ironwood’s case, it’s to help with the launch of their first commercial product, Linzess, aka linaclotide, which the FDA approved last August.)

According to Strategic Transactions, since November 2011 biotechs with market caps of $1 billion or more have raised $3.89 billion over 24 sales, an average of $162 million. Companies with market caps between $500 million and $1 billion have raised $2.59 billion over 26 sales, an average just under $100 million. And sub-$500 million cap companies have raised $4.67 billion over 142 sales, an average of $34 million.

It all reinforces the urgency for private firms to get through the IPO window, because the grass really is greener on the other side of the fence. And for now, there's plenty of pasture to graze. The upcoming Start-Up will have fewer bovine puns and more on the current IPO landscape – who’s getting to exits might surprise you -- so stay tuned. And before you exit, make sure you profit from the rest of our column. Sharpen your horns, it’s time for…

Ophthotech: The legacy of Eyetech continues. Its successor Ophthotech has raised $175 million to fund a huge Phase III trial for its wet age-related macular degeneration (AMD) candidate, Fovista. Announced May 29, the transaction comprises a $50 million Series C round for the privately held biotech, plus $125 million from long-time investor Novo AS in exchange for royalty rights to Fovista. The financing is the latest in a web of transactions involving the now-defunct Eyetech, Novo AS and other players in the ophthalmology space, including venture firm SV Life Sciences. New York-based Ophthotech was created and is led by Eyetech co-founders David Guyer and Samir Patel. Following the sale of Eyetech to OSI Pharmaceuticals, Guyer was a principal at SV Life Sciences, which focuses much of its investment on eye care companies. The Series C investors were Novo AS and Ophthotech’s other prior investors: SV, Clarus Ventures and HBM BioVentures. The same four participated in Ophthotech’s $30 million Series B round in 2009, and Novo, SV and HBM were the investors in the biotech’s $36 million Series A in 2007. But Novo AS also is ponying up $125 million against future royalties on the sale of Fovista, an anti-platelet-derived growth factor (PDGF) drug slated to start a 1,900-patient, 200-site Phase III study during the third quarter. The company declined to provide specifics on the royalty agreement, such as percentage of sales or whether the royalties would be capped by dollar amount or a certain date. – Joseph Haas

Effector Therapeutics: Effector closed a $45 million Series A round of funding, announced May 20, with commitments from seven venture firms including three tied to Big Pharma. The backers are GlaxoSmithKline’s venture firm SR One, Novartis Venture Funds, and Astellas Venture Management, as well as Abingworth, Osage University Partners, U.S. Venture Partners and Mission Bay Capital. The company plans to develop and commercialize new drugs based on discoveries at the University of California, San Francisco, concerning the process of translation, or protein synthesis. Effector believes it can create compounds that affect multiple oncogenes simultaneously, halting a key mechanism that leads to tumor growth. The company will target so-called “effector mechanisms” selectively, aiming for an upstream process that can activate more than one cancer gene at the same time. San Diego-based Effector believes that newly-discovered methods of disrupting certain malfunctioning effector mechanisms can sever a key lifeline upon which cancer cells depend. For CEO Steve Worland, Effector is a chance to build a new company from the ground up. He was CEO of publicly traded hepatitis C specialist Anadys until its sale to Roche for $230 million in October 2011.  Worland told our Pink Sheet colleagues that his involvement with Effector’s VCs “was like being an entrepreneur-in-residence at three or four firms simultaneously” as he built the syndicate. The corporate investors’ parent firms received no special rights, options, or ties to the programs Effector has underway. According to U.S. Venture Partners’ Larry Lasky, the four firms with board seats – USVP, Abingworth, SR One, and Novartis -- were the “main investors,” while the other firms contributed smaller amounts. – Paul Bonanos

Karyopharm Therapeutics
: After raising more than $30 million in its initial financing, oncology biotech Karyopharm is adding to its cash runway with a $48 million Series B. The Natick, Mass. company will use the new funds to push its lead cancer asset forward in multiple indications. Karyopharm, which was founded in 2008, has been financed largely by a private investor until now. In November 2010, the biotech attracted the attention of deep-pocketed Chione, an investment vehicle that is backed by Polish oil and gas baron Slava Smolokowski, who has also put some of his considerable fortune into Broadway. With Smolokowski’s backing, Karyopharm raised $20 million in its initial round and then added another $10 million during a follow-up offering in 2011. Chione once again has contributed to the most recent round of financing and been joined by a group of private investors, as well as one venture capital firm. Delphi Ventures now has joined the company’s investment syndicate in the latest round of financing and Deepa Pakianathan will join its board to represent Delphi’s interests. Karyopharm also has received $1 million in funding from the Multiple Myeloma Research Foundation and the founders brought in $1 million from other angel investors prior to the Series A. CEO Michael Kauffman said the company largely has avoided including venture capital investors due to the constraints that often come with VC money – particularly more rigid timelines. He said the leeway afforded by private investors was a better fit for the company. – P.B.

Ironwood Pharmaceuticals: The developer of constipation treatment Linzess (linaclotide) netted nearly $130 million in a secondary sale of 10.5 million shares of its Class A common shares at $13 a piece, a 6% discount to the previous day’s closing price. The firm could boost its proceeds if underwriters led by JP Morgan and BofA Merrill Lynch sell an additional 1.575 million shares, cash that will help the company build the recent launch of Linzess, which FDA approved in August 2012 and the EU in November 2012.  Ironwood shares US marketing duties with Forest Laboratories, a deal that was inked in 2007, and Laboratorios Almirall has exclusive European rights. It’s also brought on AstraZeneca to help sell Linzess in China and Astellas Pharma in Japan and other Asian countries. Using both debt and equity sales, the firm has raised nearly $400 million since the start of 2012. The secondary share sale is for Class A stock, notable because Ironwood long ago instituted a dual-class share structure to ensure that pre-IPO shareholders have a disproportionately large say in potential change-of-control scenarios. Holders of Class B stock get 10 votes per share in such matters. Class A holders get 1 vote per share. Starting in 2019, the dual-class structure could disappear if Class B shares total less than 25% of all outstanding Ironwood shares. According to the firm’s regulatory filings, the recent stock sales put the Class A share count at 92.9 million and Class B at 26.4 million.  – Alex Lash

All The Rest: Cardeas Pharma raised $34M in Series B to fund work on inhaled antibiotics for hospital-acquired infections… Jennerex Biotherapeutics closed on $21.6M to support lead oncolytic immunotherapy Pexa-Vec…Trinity College spin-off Trino Therapeutics raised an €9M Series ATheraCoat, focused on bladder infections, completed a $7M round led by Pontifax…neurodegenerative disease drug developer Oligomerix raised $2.6M in a Series B…concurrent with an $850k grant from Austria’s Research Promotion Agency FFG, antisense company ugichem raised €1.4M…Sofinnova led an undisclosed Series A for First Aid Shot Therapy (FAST), which is developing OTC single-serve liquid products…autoimmune and viral disease firm Kineta received funding from Hydra, an LP formed by retired oil traders…BTG completed a £106M private placement to help pay for acquisitions of interventional device companies Ekos and Nordion’s Targeted Therapies…for a total of $4.6M, Aeterna Zentaris may sell MLV & Co. up to 2.5M shares  in an "at-the-market issuance"…in a convertible preferred stock and warrants offering, Guided Therapeutics raised $2.6M…Rare disease-focused NPS Pharmaceuticals closed on an $87M secondary offeringStemline Therapeutics, which is investigating oncology therapeutics that target cancer stem cells and tumor bulk, publicly raised $60M…in a follow-on, Cyclacel Pharma grossed $20.5M to fund completion of the Phase III SEAMLESS trial for AML candidate sapacitabine…male and female sexual health company Apricus Biosciences closed a $17.1M FOPO…in the second-highest grossing IPO so far in 2012 behind Quintiles, Portola went public raising $140M... Israeli firm Alcobra completed a $25M US IPORegado set terms for their IPOs…PTC Therapeutics, Prosensa, and Evoke Pharma all joined the IPO queue and filed S-1s...Speranza Therapeutics raised $90M in funding and concurrently spun off from Elan to continue work on Phase II ELND005 for CNS indications… ElsaLys Biotech spun off from Transgene with a €2.1M Series A to support development of antibodies for cancer and infectious…Pfizer raised $4B in a five-tranche notes sale…to fund several acquisitions, Elan completed an $800M debt offeringImmuPharma received a £50M loan from Darwin Strategic to support Phase III studies of lupus candidate Lupuzor…and VentureHealth set up an equity crowdfunding portal to improve clinical outcomes. -- Amanda Micklus

Many thanks to Stacy Lawrence for help with this week's column. 

Photo courtesy of Flickr user Stephan Andrej Shambora

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