BioShares Biotechnology Clinical Trials (BBC): $20.55, -$0.11, +11.6% YTD

BioShares Biotechnology Products (BBP): $36.72, -$0.31, +12.1% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures and the dollar were trading lower after the new U.S. finance chief poured a little cold water on the "Trumpflation trade". Treasury Secretary Steven Mnuchin said that any steps that U.S. President Donald Trump’s administration takes on policy would probably have only a limited impact this year. European bourses fell as investors assessed earnings updates from some of the major companies, including Saipem and RBS, while a sudden fall in copper and other commodity prices weighed on Asian stock markets. Gold rose to its highest level in over three months and oil prices slipped as increased U.S. crude inventories continued to fuel oversupply concerns.

 

 

MARKET HIGHLIGHTS

 

Heron Therapeutics announced the inclusion of SUSTOL® (granisetron) extended-release injection as part of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis Version 1.2017.  The NCCN has given SUSTOL a Category 1 recommendation, the highest level category of evidence and consensus, for use in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving HEC or MEC regimens. Importantly, the guidelines identify SUSTOL as a “preferred” agent for preventing CINV following MEC. Further, the guidelines highlight the unique, extended-release formulation of SUSTOL.

 

Heron Therapeutics reported fourth quarter and full year 2016 financial results.  As of December 31, 2016, the Company had cash, cash equivalents and short-term investments of $51.1 million. In January 2017, the Company completed an underwritten public offering of 14.1 million shares of our common stock for net proceeds of $163.7 million. As of December 31, 2016, the Company had pro-forma cash, cash equivalents and short-term investments, adjusting for the January 2017 public offering, was $214.8 million. This compares to $131.2 million in cash, cash equivalents and short-term investments as of December 31, 2015.  The Company’s net loss for the quarter and year ended December 31, 2016 was $48.0 million and $173.1 million, or $1.22 per share and $4.56 per share, respectively, compared to a net loss of $31.2 million and $97.6 million, or $0.87 per share and $2.95 per share, respectively, for the same periods in 2015.

 

Bioblast Pharma announced financial results for the fourth quarter ended December 31, 2016.  For the quarter ended December 31, 2016, net loss attributable to holders of ordinary shares was ($3.1) million, or ($0.19) per basic and diluted share, as compared to a net loss of ($4.8) million, or ($0.34) per share, for the same period in 2015.  Cash, cash equivalents and short-term bank deposits as of December 31, 2016 were $9.9 million, compared to $12.9 million as of September 30, 2016, primarily reflecting the Company’s fourth quarter operating expenditures.

 

OncoSec Medical will host a Key Opinion Leader event to highlight new clinical data that will be featured as an oral and poster presentation at the upcoming 2017 ASCO-SITC Immuno-Oncology Symposium and the Company’s melanoma development plan. The KOL event will be held in-person and via live webcast on Tuesday, February 28 at 12:00 PM EST at the Lotte New York Palace Hotel in New York City.

 

La Jolla Pharmaceutical Company reported fourth quarter and full year 2016 financial results.  As of December 31, 2016, La Jolla had $65.7 million in cash and cash equivalents, compared to $126.5 million as of December 31, 2015. Based on current operating plans and projections, La Jolla believes that its current cash and cash equivalents are sufficient to fund operations into 2018.  La Jolla’s net loss for the three and twelve months ended December 31, 2016 was $24.9 million and $78.2 million, or $1.44 per share and $4.54 per share, respectively, compared to a net loss of $11.8 million and $41.9 million, or $0.69 per share and $2.68 per share, respectively, for the same periods in 2015.

 

Achaogen announced the promotions of Blake Wise to President and Chief Operating Officer, Lee Swem, Ph.D., to Senior Vice President and Chief Scientific Officer and Zeryn Sarpangal to Senior Vice President of Corporate and People Strategy.

 

Cempra announced positive topline results from a Phase III study of oral fusidic acid in 716 patients with acute bacterial skin and skin structure infections (ABSSSI). Fusidic acid was well tolerated in the study and achieved the primary endpoint, demonstrating non-inferiority (NI) (10% NI margin) of oral fusidic acid compared to oral linezolid for early clinical response (ECR) in the intent to treat (ITT) patient population.

 

China Biologic reported 4Q16 GAAP EPS of $0.69, which compares to $0.59 for the same period a year ago. The company beat the GAAP EPS mean estimate of $0.66. Total revenue for 4Q16 was $77.6 million, which compares to $68.3 million for the same period a year ago. This compares to a mean estimate of $76.6 million.

 

After yesterday’s close, Ligand Pharmaceuticals reported 4Q16 non-GAAP EPS of $1.25, which compares to $0.69 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $1.19. Total revenue for 4Q16 was $38.2 million, which compares to $21.2 million for the same period a year ago. This compares to a mean estimate of $40.3 million. Following Ligand’s earnings, Deutsche Bank analyst Gregg Gilbert decreased his price target to $100 from $105.

 

After yesterday’s close, BioMarin Pharmaceuticals reported 4Q16 GAAP EPS loss of $0.53, which compares to $0.39 for the same period a year ago. The company missed the GAAP EPS mean estimate loss of $0.38. Total revenue for 4Q16 was $300.1 million, which compares to $227.9 million for the same period a year ago. This compares to a mean estimate of $296.0 million. Following Biomarin’s earnings, Goldman analyst Salveen Richter increased her price target to $129 from $126; BMO analyst Ian Somaiya decreased his price target to $112 from $115; Credit Suisse analyst Kennen MacKay increased his price target to $112 to $107; Raymond James analyst Christopher Raymond decreased his price target to $102 from $108; Leerink analyst Joseph Schwartz decreased his price target $122 from $125; JP Morgan analyst Cory Kasimov decreased his price target to $123 from $127.

 

Intellipharmaceutics International announced that the Company received final approval from the FDA for the Company’s ANDA for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths. The Company’s newly approved product is a generic equivalent for the corresponding strengths of the branded product Glucophage XR sold in the United States by Bristol-Myers Squibb.

 

Celgene International Sàrl, a wholly-owned subsidiary of Celgene, announced that the European Commission (EC) has approved REVLIMID (lenalidomide) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT). REVLIMID is the first and only licensed maintenance treatment available to these patients.

 

Auris Medical Holding announced that the FDA has granted Fast Track designation for AM-111 in the treatment of acute sensorineural (inner ear) hearing loss (ASNHL).

 

Nivalis Therapeutics announced topline results from the Company’s Phase II trial evaluating the efficacy and safety of cavosonstat at a dose of 400 mg in adult patients with CF who had one copy of the F508del-CFTR mutation and a second gating mutation, and were being treated with Kalydeco (ivacaftor). There were no dose limiting toxicities and cavosonstat was well tolerated in the trial. Cavosonstat, when added to Kalydeco therapy, did not demonstrate benefit in absolute change in percent predicted FEV(1, )the trial’s primary endpoint, or in sweat chloride reduction at 8 weeks.

 

Novartis announced the CHMP of the EMA adopted a positive opinion recommending approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600 mutation. If approved, Tafinlar + Mekinist will be the first targeted treatment available for patients with BRAF V600-positive NSCLC. Of the estimated 1.8 million new cases of lung cancer diagnosed worldwide each year, 1-3%, may be driven by the BRAF mutation.

 

Celgene announced that President and Chief Operating Officer (COO) Jacqualyn Fouse, Ph.D., has decided to retire from Celgene effective June 30, 2017. She will continue to serve as President and COO until April 1, and through June 30, she will serve as a strategic advisor to the management team. Jackie will not stand for reelection to the Celgene Board of Directors at the upcoming Annual Meeting in June. The Company also announced the promotion of Scott Smith to President and COO, effective April 1, 2017, and the promotion of Terrie Curran to President, Global Inflammation & Immunology Franchise, effective April 1, 2017.

 

Galapagos announced dosing of the first healthy volunteer with a combination of novel corrector GLPG2222 and novel potentiator GLPG2451 for cystic fibrosis in a Phase I study. After completion of the dosing of GLPG2451 as a monotherapy, in the new cohorts the safety, tolerability and PK of 14 days co-administration of GLPG2451 and GLPG2222 is being evaluated. The randomized, double-blind, placebo controlled, single center study is being conducted in at least 40 healthy volunteers in Belgium.

 

Genmab announced that the CHMP of the EMA has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX (daratumumab) in the European Union. The recommendation is for the use of DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The variation to the Marketing Authorization for this indication was submitted to the EMA in August 2016. In August 2012, Genmab granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

 

Shire announced that the CHMP of the EMA has adopted a positive opinion recommending the granting of Conditional Marketing Authorization for Natpar (rhPTH[1-84]), a recombinant human protein with the full length 84-amino-acid sequence of endogenous parathyroid hormone (PTH), as an adjunctive treatment for adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.

 

Boehringer Ingelheim Pharmaceuticals announced results from a real-world analysis showing that Pradaxa (dabigatran etexilate mesylate) was associated with an improvement in safety and efficacy outcomes compared to warfarin in patients with non-valvular atrial fibrillation (NVAF). The results were presented at the International Stroke Conference.

 

Merck announced that the CHMP has granted a positive opinion for the new Pergoveris Pen.

 

ANI Pharmaceuticals announced that it has acquired Inderal XL from Cranford Pharmaceuticals and InnoPran XL  from Holmdel Pharmaceuticals LP.  The acquired assets include the NDA and trademark for InnoPran XL including a license to an Orange Book listed patent, and a distribution license and trademark for Inderal XL as well as finished goods inventory of both products.  Inderal XL and InnoPran XL are currently available in 80mg and 120mg sustained release capsules and are indicated for hypertension.  Inderal XL and InnoPran XL generated combined sales of $23.3 million in calendar year 2016, according to IMS Health.  The acquisitions were funded through a combination of cash and debt.

 

Provectus Biopharmaceuticals provided additional information regarding the deadline to participate in its previously announced rights offering of up to 19 million units, consisting of shares of common stock and Series C Convertible Preferred Stock to existing stockholders and holders of listed warrants.

 

 

ANALYST RECOMMENDATIONS

 

Cowen analyst Tyler Van Buren initiated coverage of Aerie Pharmaceuticals with an “outperform” rating and a $70 price target, citing Aerie will be a prime consolidation candidate following the likely positive Mercury 2 results in Q2.

 

JP Morgan analyst Anupam Rama initiated coverage of Clearside Biomedical with an “overweight” rating and $19 price target, citing proof-of-concept for Clearside’s microinjected Zuprata to safely deliver the corticosteroid triamcinolone acetonide into the suprachoroidal space (SCS) has been established in multiple indications.

 

Oppenheimer analyst Jay Olson upgraded Portola Pharmaceuticals to “outperform” from “perform” and increased his price target to $40 from $28, citing model adjustments in the wake of the FDA mid-cycle feedback stating no Ad Com would be required for betrixaban as of now.

 

Maxim analyst Lauren Chung initiated coverage of MYnd Analytics with a “buy” rating and $18 price target, citing MYnd Analytics is a solution provider with proprietary software algorithms that interpret EEG results (individual neurophysiology) for physicians to use to choose the right medications for their patients.

 

Morgan Stanley analyst David Risinger decreased his price target of Teva to $36 from $38, citing the uncertain timing of Copaxone erosion will continue to weigh on the multiple.

 

Following Novocure’s earnings, Deutsche Bank analyst Gregg Gilbert decreased his price target to $10 from $15.