Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
In a (Mostly) Record Year for Biopharma Stocks, These Public Companies Made the Most for Investors
Until the threat of price curbs started driving investors away in September, biotech stocks enjoyed a blissful 2015 marked by record high share prices and a ballooning number of initial public offerings. But the market swoon that sent shares falling late last year didn’t completely wipe out gains for stocks—at least according to the results of two key exchange-traded funds.
The iShares NASDAQ Biotechnology Exchange-Traded Fund finished 2015 at $338.33, up 11.5%—better than nothing, though not as good as the 31% gain recorded for the year as of July 20, when the fund reached its all-year high of $398.00.
Also reaching its 2015 peak on July 20 was the First Trust New York Stock Exchange Arca Biotechnology Index Fund, which finished that day at $131.19, up 29% for the year. But at the close of trading on December 31, the NYSE fund managed a finish of only $113.02, posting a gain of just under 11% for the year. Again, it could have been worse, but it could have been much better, too.
Eking out smaller gains were two other biotech funds, PowerShares Dynamic Pharmaceuticals Exchange-Traded Fund (reaching $69.97, up 5%) and iShares US Pharmaceuticals (reaching $161.69, up 6.8%).
Below is a list of the top 10 best stock performers of 2015. Each item in the list presents a top stock performer’s basic information: company name; stock exchange; trading symbol; closing prices as of December 31, 2015 and December 31, 2014; percentage rise or fall in the closing prices; and brief summary of the factors accounting for company’s good fortune.
As was the case last year, 2015’s top performers were up-and-coming companies, small- to mid-capitalization (“small cap” to “mid cap”) stocks that jumped in value as a result of marketing approvals, positive clinical trials results, or other news announcements and/or speculation about possible acquisition.
Not included on this list are companies that went public during 2014 and, as a result, generated less than a year’s share-price data. Also not listed are companies that appeared to show even larger price gains, but only as a result of reverse stock splits.
December 31, 2015: $2.21
December 31, 2014: $0.79
% Change: 179.7%
The company enjoyed a doubling of its share price between March 2 and March 30, following the announcement of its Epigenomic Regulator Program, and successful completion of a Phase I clinical trial with the program's lead product candidate DUR-928. The results of that trial caused shares to jump another 43% between May 18 and June 5, when the price reached its all-year high of $3.23. The results were, namely, favorable safety data from a multi-dose trial of DUR-928, a potential treatment for metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). DUR-928 may also be a treatment for acute kidney injury (AKI) and other types of acute organ injury, the company added. DUR-928 advanced to a single-ascending-dose Phase Ib trial in patients with NASH in January of this year.
#9. Anthera Pharmaceuticals
December 31, 2015: $4.64
December 31, 2014: $1.58
% Change: 193.7%
Shares of company stock more than doubled between May 22 and June 18, reaching $9.59 at the end of this period, two days after the company said that it had met its enrollment target for the CHABLIS-SC1 Phase III clinical trial evaluating blisibimod for the treatment of lupus. The company regained full global rights to the compound in September after its development partner in Japan, Zenyaku, terminated a collaboration to co-develop the drug there. Rather than sell off shares, investors sent them 21% higher, to $9.60, between the day of the termination announcement September 14 and September 18. Another 49% increase took place between July 9 and July 27, when shares reached their all-year high of $11.11. The surge coincided with a public offering of stock that raised net cash proceeds of approximately $26.9 million, the company disclosed in its third-quarter Form 10-Q regulatory filing. The company’s first significant stock gain of 2015 was a 25% bump, to $3.25, on February 10, the day the company trumpeted a successful completion of an interim analysis of CHABLIS-SC1.
#8. Intra-Cellular Therapies
December 31, 2015: $53.79
December 31, 2014: $17.65
% Change: 204.8%
September 16 proved to be a red-letter day for the company, after it released results from the first Phase III study of lead compound ITI-007 for schizophrenia. Those results showed statistically significant improvement in patients' Positive and Negative Syndrome Scale (PANSS) total score at the 60 mg dose, compared to placebo, with motoric, metabolic, and cardiovascular characteristics similar to placebo. Shares nearly doubled, zooming 87% to $48.79 the day of the announcement, followed by another 20% the next day, to its high for the year of $58.62. Less than two weeks later, on September 28, the company completed a $345 million offering of common stock, generating net proceeds of approximately $327.4 million. Despite a selloff by investors, the company grew its total cash to more than $510 million—then launched a Phase III study of ITI-007 in bipolar depression on December 23, helping send shares 7% higher five days later, to $56.39 on December 28.
#7. Recro Pharma
December 31, 2015: $9.00
December 31, 2014: $2.86
% Change: 214.7%
Share prices more than quadrupled between March 2 and April 15, reaching $14.04. The surge coincided with Recro acquiring from Alkermes worldwide rights to intravenous/intramuscular meloxicam, a Phase III-ready, long-acting COX-2 NSAID for moderate to severe acute pain; a contract manufacturing facility in Gainesville, GA; and royalty and formulation revenue associated with the facility. Recro shelled out $50 million up front and agreed to provide Alkermes up to $125 million in milestone payments under that deal, which was announced March 9 and completed April 13. Shares of the company enjoyed two higher peaks in 2015. The price ballooned 18% between July 14 and July 21, reaching $17, four days after the company announced positive efficacy results in the Phase II clinical trial of Dex-IN, an intranasal formulation of dexmedetomidine, for acute pain in adult patients undergoing bunionectomy surgery. And from September 1 to 18, shares climbed 33%, peaking at the all-year high of $17.11, with the only clinical news during the period being data presentations at PAINWeek®, the National Conference on Pain for Frontline Practitioners, from two studies for N1539, an intravenous formulation of NanoCrystal Colloidal Dispersion® meloxicam for managing acute moderate to severe pain.
December 31, 2015: $68.11
December 31, 2014: $20.76
% Change: 228.1%
Once the early-stage R&D arm of Elan before being spun off in 2012, the company three years later made a name for itself with investors. Shares surged 32%, to $38.66, on March 20, the day after the company released positive Phase I results for PRX002, a Parkinson’s disease treatment being co-developed with Roche—which will provide Prothena up to $555 million in milestone payments on top of the $45 million up-front payment provided when the collaboration began in 2013. PRX002 represents a potential advance over current treatments for Parkinson’s that manage only early motor symptoms. Between October 13 and November 27, shares rocketed 74%, to $75.31, following an accelerated clinical development timeline for NEOD001. The company began a global Phase IIb trial in previously treated patients with amyloid light-chain (AL) amyloidosis and persistent cardiac dysfunction, while completing enrollment in an expansion cohort of a Phase I/II trial of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction. Data is expected in the second quarter of 2016.
#5. Sophiris Bio
December 31, 2015: $1.78
December 31, 2014: $0.54
% Change: 229.6%
The company’s Wall Street success stemmed not from a series of upbeat announcements but from a pair of clinical developments that included positive clinical trial result for its single drug candidate. On November 10, the company said that PRX302 (topsalysin) had met its endpoint in the Phase III PLUS-1 trial, which assessed its effect on lower urinary tract symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate. PRX302 showed statistically significant improvement in total International Prostate Symptom Score (IPSS) from baseline over 12 months compared to a vehicle-only control group. Investors warmed to the good news as shares more than tripled, skyrocketing 237% to $2.90 before rising another 10%, to $3.20, on November 11. Before then, the company enjoyed a 21% jump in share price, to $1.08, on May 27, the day after it was disclosed the first patient was enrolled in a Phase IIa proof-of-concept trial of PRX302 for localized low- to intermediate-risk prostate cancer.
#4. Anacor Pharmaceuticals
December 31, 2015: $112.97
December 31, 2014: $32.25
% Change: 250.3%
July was a sizzling hot month for the company. It wasn’t the weather, but a strong pair of Phase III trial results for crisaborole, a treatment for mild to moderate eczema. The PDE-4-inhibiting topical ointment met its primary and secondary endpoints in the pivotal studies, prompting the company to plan a first-half 2016 NDA filing with the FDA—and sending the share price 56% higher, to $131.93, on July 13; shares kept climbing, reaching $152.25 on August 4. Investors also warmed to the company because of growing revenue for Kerydin® (tavaborole), a toenail fungus treatment marketed by Novartis’ Sandoz unit following FDA approval in 2014. During the third quarter, the company racked up $21.1 million in total Kerydin revenue, up 18.8% over Q2 2015; shares rose 33%, to $122.09, between October 22 and the release of Q3 results on November 3.
December 31, 2015: $5.64
December 31, 2014: $1.44
% Change: 291.7%
The company placed at number 3 on GEN’s List of Wall Street Losers of 2014, after axing about 70% of its workforce (160 jobs) following a Phase III trial failure for Cometriq® (cabozantinib) in metastatic castration-resistant prostate cancer. But in 2015, the company was a Wall Street winner, thanks in part to share prices spiking upward 50%, reaching $5.88 on July 20 following positive Phase III results for a reformulated Cometriq in advanced renal cell carcinoma, showing it reduced the risk of disease progression or death by 42% compared to Afinitor (everolimus). The company submitted an NDA for Cometriq to the FDA on December 23. The company hopes to repeat the success it enjoyed in November, when the FDA and the European Commission both approved Cotellic™ (cobimetinib) in combination with Genentech’s Zelboraf® (vemurafenib) for advanced melanoma. Genentech parent Roche will share profits from Cotellic with the company—whose shares jumped 19% between August 24 and 27, reaching $6.08 the day Cotellic won its first approval, in Switzerland.
#2. Eagle Pharmaceuticals
December 31, 2015: $88.67
December 31, 2014: $15.50
% Change: 472.1%
The Eagle has landed … near the top of this list, thanks to several positive announcements. The most notable of them was Teva Pharmaceutical Industries agreeing in February to exclusively license the company’s Bendeka™ (formerly EP-3102; bendamustine hydrochloride), a rapid infusion product indicated for chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma. Teva shelled out $30 million up front and up to $90 million in milestone payments, and has agreed to pay a 20% royalty on net sales following FDA approval—plus additional royalties tied to achieving future milestones. Shares zoomed 41%, to $36.75, on February 18, the day after the Teva announcement. On December 8, shares zoomed 22%, to $100.21, after Eagle said it won FDA approval for Bendeka, earning it a $15 million milestone payment from Teva.
#1. Nymox Pharmaceutical
December 31, 2015: $3.28
December 31, 2014: $0.40
% Change: 720.0%
What a difference a year makes. The biggest of the Wall Street Losers of 2014 turned into the second-biggest Wall Street Winner on Phase III results for the same drug candidate, NX-1207 (fexapotide triflutate), that had been looking less than sterling just a year earlier. In 2014, shares fell 82% after a pair of pivotal studies failed to meet their primary endpoint of statistically significant efficacy compared with placebo. But on July 27, shares doubled to $2.54 following positive long-term results from the same studies, NX02-0017 and NX02-0018, which had been initiated in 2009. The benign prostatic hyperplasia (BPH) treatment showed superior statistically significant benefit compared to placebo 3-1/2 years following injection. Two other Phase III studies (NX02-0020 and NX02-0022) showed significant reduction of BPH surgery within 24 months of treatment. Shares also jumped 21%, to $3.51, on October 29, the day Nymox reported positive 18-month follow-up results for NX-1207 in low-grade localized prostate cancer, and kept climbing another 9%, to $3.83, on November 3.