Leerink Presents: Your 2017 Biopharma Catalyst Tracker

Celgene — Multiple Readout In 2017

On Celgene Corporation CELG, the firm noted that it has multiple readouts across I&I and oncology in 2017. However, most of the events are back-end loaded, the firm said.

By year-end 2017, the company has many key events, including submission of ozanimod NDA in multiple sclerosis, results of separate late-stage studies on Revlimid in newly diagnosed and R/R FL, Otezla in Behcet's disease and Abraxane in Adjuvant pancreatic cancer. In the second half, the company is expecting Enasidenib in IDH2 + AML.

Alexion — Positioned For Important News In 2017

Leerink believes Alexion Pharmaceuticals, Inc. ALXN is well positioned for important news in 2017. FDA PDUFA date for Soliris is set for some time in the third quarter and the first Phase III trial results for ALXN 1210 are expected by the end of 2017.

Regeneron Has Critical Events

According to Leerink, critical events for Regeneron Pharmaceuticals Inc REGN, include Dupixent approval, label and price. The Dupixent PDUFA date is set for March 29, 2017. The firm expects Kevzara approval in the second quarter. The catalysts scheduled for the second half include Odyssey outcomes, Dupixent asthma pivotals, nesvacumab phase II.

Vertex To Benefit From Disclosures, Risk Reduction

Leerink expects Vertex Pharmaceuticals Incorporated VRTX to benefit from significant disclosures and risk reduction from its second and third generation Cystic Fibrosis multi-drug combination. The results of the first two pivotal trials for Vx661 are due in the first and second quarter.

Leerink said the company is scheduled to disclose several small trials in the second half of 2017, which could establish clinical proof of principle for its high impact triple combination of CFTR correctors and potentiator.

Big Pharma Catalysts

Analyst Seamus Fernandez said catalysts for big pharma on immuno-oncology in 1L lung cancer include:

• PDUFA date for Merck & Co., Inc.MRK's Keytruda + chemo doublet — May 10.
• Eli Lilly and Co LLY MONARCH-2 study of its CDK4/6 inhibitor, abemaciclib, for 2L ER+/HER2- breast cancer — Mid Year.
• Full data from AstraZeneca plc (ADR) AZN's SOLO-2 trial (Lynparza) at SGO — March 14.
• Progression free survival results from AstraZeneca's MYSTIC trial in mid-2017.
• PDUFA date for TESARO Inc TSRO niraparib — June 30.
• Results from Clovis Oncology Inc CLVS's ARIEL3 trial (Rubraca) — mid-2017.

Top Small And Mid-Cap Catalysts For The First Half

Intra-Cellular Therapies Inc ITCI is expected to meet with the FDA in 1Q17 to discuss ITI-007 for schizophrenia treatment and communicate its regulatory strategy after the meeting.

Specialty Pharma Catalysts

For specialty pharma companies, catalysts are balanced between data readouts and legal events. Leerink noted a total of 16 high-impact catalysts in the first half of 2017, evenly split with data catalysts and legal/regulatory events.

• Leerink is convinced of positive outcomes on Forward Pharma A/S FWP patent interference ruling by the end of March.
• The firm also expects Jazz Pharmaceuticals plc - Ordinary Shares JAZZ to reach a Xyrem patent settlement with lead challenger Hikma Pharmaceuticals Plc (ADR) HKMPY, yielding +11 percent upside ahead of a May patent trial date.
• Leerink is bearish on Mylan N.V. MYL ability to secure a generic Advair approval on first cycle review, which could be a negative for the stock.
• The firm also expressed conviction around Shire PLC (ADR) SHPG's SHP643 reporting positive Phase 3 data for HAE prophylaxis based on validated mechanism and strong supportive data.
• The firm is also bullish on Ardelyx Inc ARDX's tenapanor reporting favorable Phase 3 top line for constipation by mid-2017, leading to meaningful upside to the stock.
• Mallinckrodt PLC MNK's INOMax patent trial with Praxair.
• Pacira Pharmaceuticals Inc PCRX's Exparel Phase 3 data — "We believe the we/Street already give the company credit for the indication, creating asymmetric risk/reward into data."
• Endo International plc - Ordinary Shares ENDP's Opana ER — an upcoming FDA AdCom could result in the FDA removing the product from the market.

Ratings

• Alexion — Outperform.
• Astrazeneca — Outperform.
• Celegene — Market Perform.
• Eli Lilly — Outperform.
• Endo International — Market Perform.
• Intra-Cellular Therapies — Outperform.
• Jazz Pharma — Outperform.
• Mallinckrodt — Outperform.
• Merck — Market Perform.
• Mylan — Outperform.
• Pacira Pharma — Market Perform.
• Regeneron — Outperform.
• Tesaro — Market Perform.
• Vertex — Outperform.

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