12:00 AM
Oct 07, 2013
 |  BioCentury  |  Finance

3Q Stock Wrap-Up: Make it a double

All biotech tiers up in 3Q13; large caps up 46% on the year

For the second time this year, all market cap segments closed the quarter in the black. Large caps valued at $5 billion and above gained ground for the fifth consecutive quarter. They added 12%, and are up 46% year to date.

Large caps were led by Pharmacyclics Inc., which gained 74% in 3Q13 to $138.26.

In early July, the stock rose after the company submitted an NDA to FDA for ibrutinib to treat hematological cancers. In August, the agency granted the Bruton's tyrosine kinase (Btk) inhibitor Priority Review with a Feb. 28 PDUFA date.

The stock also was spurred by a late September analyst note in which Deutsche Bank began coverage with a buy rating and a $170 target.

There were only three decliners in the group, the fewest since 3Q12. The losers were Japanese diagnostic company Sysmex Corp., Teva Pharmaceutical Industries Ltd. and Vertex Pharmaceuticals Inc. All three fell less than 6% in 3Q13.

Celldex Therapeutics Inc. led the $1-$4.9 billion group, posting a 127% gain for the quarter to $35.43. The company got a bump at the beginning of the quarter when it started a Phase I trial of CDX-1135 for membranoproliferative glomerulonephritis.

The majority of the upside came late in the quarter after a Leerink Swann analyst increased his price target to $45 from $28.

NPS Pharmaceuticals Inc. was up 111% in 3Q13, second among the mid-caps. In August, the company reported 2Q13 net Gattex teduglutide sales of $4.8 million, beating the Street's $2.5 million estimate for the short bowel syndrome (SBS) drug. The company also introduced 2013 Gattex sales guidance of $25-$30 million.

In its first full quarter of trading, ReproCell Inc. tumbled 41%, making it the poorest performer among mid-caps. The Japanese stem cell company went public in late June and ended 3Q13 at a 32% discount to its IPO price.

By contrast, a weighted index of Japanese biotechs was up 27% for the quarter.

The top performers in the $200-$999 million group were specialty pharmas Insys Therapeutics Inc. and Orexo AB. In August, Insys reported diluted EPS of $0.26, handily beating the Street's $0.12 estimate.

Insys, which gained 153% during the quarter, markets its Subsys fentanyl sublingual spray in the U.S to treat breakthrough cancer pain in opioid-tolerant patients.

Orexo closed up 124% on two approvals. Early in the quarter, FDA approved the Swedish biotech's Zubsolv buprenorphine/naloxone for maintenance treatment of opioid dependence. Orexo launched the drug in September.

Also in September, Japan approved breakthrough pain drug Abstral fentanyl from partner Kyowa Hakko Kirin Co. Ltd.

GTx Inc. was the laggard in the $200-$999 million segment, closing down 69%. The company tumbled after its enobosarm failed in a pair of Phase III trials to prevent and treat muscle wasting in patients with non-small cell lung cancer (NSCLC) receiving chemotherapy.

Microcaps ended the quarter up 7%. The top gainers were BioCryst Pharmaceuticals Inc., Plethora Solutions Holdings plc and Summit Corp. plc, all of which rose at least 330%.

In July, BioCryst announced positive Phase I data for hereditary angioedema (HAE) compound BCX4161 in healthy volunteers. Later in the quarter, FDA lifted a clinical hold on the oral compound and BioCryst raised $17.6 million in a follow-on.

Most of Plethora's move came in September. EMA's CHMP issued a positive opinion recommending approval of an MAA for Lidocaine Prilocaine Plethora, a topical analgesic spray to treat primary premature ejaculation in men. Plethora has rights from the Sciele Inc. subsidiary of Shionogi & Co. Ltd.

Summit gained in August when it received a U.S. patent protecting SMT C1100, which is in development to treat Duchenne muscular dystrophy (DMD), and moved up again in September after presenting positive Phase I and preclinical data for SMT 19969 to treat Clostridium difficile infection (CDI).

SMT C1100 is a small molecule utrophin up-regulator and SMT 19969 is a heterocyclic small molecule oral antibiotic.

On the flip side, KV Pharmaceutical Co. fell 98% in 3Q13. The company, which markets preterm birth drug Makena hydroxyprogesterone caproate, emerged from Chapter 11 bankruptcy last month.

Companies and Institutions Mentioned

BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX), Durham, N.C.

Celldex Therapeutics Inc. (NASDAQ:CLDX), Needham, Mass.

GTx Inc. (NASDAQ:GTXI), Memphis, Tenn.

Insys Therapeutics Inc. (NASDAQ:INSY), Phoenix, Ariz.

KV Pharmaceutical Co. (OTCQB:KVPHQ), St. Louis, Mo.

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151), Tokyo, Japan

NPS Pharmaceuticals Inc., Bedminster, N.J.

Orexo AB (SSE:ORX), Uppsala, Sweden

Pharmacyclics Inc. (NASDAQ:PCYC), Sunnyvale, Calif.

Plethora Solutions Holdings plc (LSE:PLE), London, U.K.

ReproCell Inc. (JASDAQ:4978), Yokohama, Japan

Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507), Osaka, Japan

Summit Corp. plc (LSE:SUMM), Abingdon, U.K.

Sysmex Corp. (Tokyo:6869), Kobe, Japan

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Cambridge, Mass.


3Q approvals and 3Q setbacks
Company Approval
Actelion Ltd. (SIX:ATLN) FDA approves Valchlor mechlorethamine to treat stage IA and IB mycosis fungoides, a type of cutaneous T cell lymphoma (CTCL)
Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) EC approves Lojuxta lomitapide to treat homozygous familial hypercholesterolemia (hoFH)
Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) Japan approves Soliris eculizumab to treat atypical hemolytic uremic syndrome (aHUS)
Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) EC approves Iclusig ponatinib to treat chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)
Astellas Pharma Inc. (Tokyo:4503) FDA approves Astagraf XL tacrolimus extended-release capsules to prevent organ rejection in adult kidney transplant recipients
Bavarian Nordic A/S (CSE:BAVA) EC approves Imvanex smallpox vaccine for active immunization against smallpox disease for the general adult population, including those with...

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