March 9, 2017: UBS initiates Vertex Pharmaceuticals Inc with a Buy rating and a price target of $106. UBS is launching coverage of US Biotechnology with a positive outlook buoyed by (1) a better line-up of drug launches for 2017 (Biogen’s Spinraza for SMA; Regeneron’s Dupixent for atopic dermatitis, and Incyte’s Olumiant for rheumatoid arthritis), (2) a rich calendar of high-profile catalysts around key pivotal datasets, and (3) numerous early stage datasets for drugs not yet in most Street models.
January 25, 2017: Vertex Pharmaceuticals Inc reports Q4 EPS of $0.35 versus the $0.26 estimate. Revenue also beat coming in at $458.7 million versus the $449 million estimate.
Vertex CEO Jeffrey Leiden said, “2016 was a very important year for Vertex. It was marked by significant CF revenue growth from approximately $980 million in 2015 to approximately $1.7 billion in 2016. Additionally, our progress toward treating more people with CF continued in 2016 with the approval of ORKAMBI for children ages six to eleven in the U.S., the advancement of two next-generation correctors into Phase 2 development, and identifying two additional next-generation correctors for Phase 1 development. As we enter 2017, we anticipate continued revenue and earnings growth and additional important progress toward our long-term goal of treating all people with CF.”
January 11, 2017: Vertex Pharmaceuticals announced that it has entered into a licensing agreement with Merck KGaA, Darmstadt, Germany for the worldwide development and commercialization of four promising research and development programs that represent novel approaches to the treatment of cancer. As part of the agreement, Merck KGaA, Darmstadt, Germany will license two clinical-stage programs targeting DNA damage and repair, along with two additional novel pre-clinical programs. Vertex will receive an upfront payment of $230 million, in addition to royalties on future net sales. Merck KGaA, Darmstadt, Germany will assume full responsibility for the development and commercialization of all the programs.
The two clinical-stage programs represent first-in-class approaches to inhibit the DNA repair pathways that are fundamental to the survival and proliferation of certain cancers:
– An ataxia telangiectasia and Rad3 related (ATR) protein kinase inhibitor program comprised of two compounds, VX-970 and VX-803. VX-970 is being investigated broadly through 10 ongoing Phase 1 and Phase 2 trials across a variety of tumors and patient subtypes expected to be responsive to ATR inhibition based on biomarker data. Preliminary VX-970 clinical data were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2016 American Association for Cancer Research (AACR) Annual Meeting. VX-803 is an orally dosed ATR inhibitor currently in Phase 1 trials evaluating escalating doses of VX-803 alone and in combination with chemotherapy.
– A DNA-dependent protein kinase (DNA-PK) inhibitor program including the clinical candidate VX-984. A Phase 1 trial is now evaluating escalating doses of VX-984 alone and in combination with pegylated liposomal doxorubicin in subjects with advanced solid tumors. Merck KGaA, Darmstadt, Germany will combine these assets with its existing DNA-PK assets into a single development program.
The pre-clinical programs include one immuno-oncology program against an attractive target with first-in-class potential, and a program against a completely novel target. For both of these programs, Vertex research has demonstrated efficacy in relevant pre-clinical models, including demonstration of combination potential with immune checkpoint inhibition for the immuno-oncology program. Merck KGaA, Darmstadt, Germany will continue to characterize the Vertex compounds in these programs with the goal of taking them forward into the clinic.
The strength of the oncology R&D program at Merck KGaA, Darmstadt, Germany, including a leading presence in immunotherapy and DNA damage and repair, demonstrates how the company is re-imagining the way cancer can be treated.
The collaboration, and the related $230 million upfront payment, is subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
January 8, 2017: Vertex Pharmaceuticals guides FY16 revenue of $1.68 billion versus $1.7 billion estimate. Quarterly earnings growth YOY is set to come in at more than 59%.
Vertex Pharmaceuticals entered 2017 with approximately $1.43 billion in cash, cash equivalents and marketable securities. As of December 31, 2016, Vertex had $300 million outstanding from a credit agreement.
Vertex Pharmaceuticals said, “In 2016, the number of people with cystic fibrosis treated with ORKAMBI and KALYDECO increased significantly and we advanced our broad pipeline of medicines in development for CF, said Dr. Leiden. Entering 2017, we expect to continue to increase the number of people treated with our medicines and to generate important data from multiple medicines across our CF pipeline. Our progress has positioned us well to reach our long-term goal of treating all patients with CF with medicines that treat the underlying cause of the disease.”
December 21, 2016: Credit Suisse reiterates an Outperform rating on Vertex Pharmaceuticals and set a price target of $100. Long term Credit Suisse thinks Vertex remains the dominant player in cystic fibrosis (CF). They view the GLPG1837 data released yesterday as interesting but early and think Kalydeco has set a high bar for efficacy. Galapagos reported Phase 2 data in patients from their potentiator, GLPG1837. In the study, 25 Kalydeco patients underwent a one week washout and were then dose escalated on GLPG1837 for three weeks. After the three weeks of treatment, ppFEV1, a key clinical metric in CF, returned to the Kalydeco pre-washout levels, suggesting clinical activity. There was also a dose dependent impact on sweat chloride, another important marker of activity in CF. One patient dropped out of the study due to an increase in non-cardiac creatine phosphokinase. Firm is curious to learn more around this patient case and if any other creatine phosphokinase elevations are seen in further studies. Per comments the call, the company does not know exactly what happened with this case. Kalydeco has a well-established safety record and they think a potential competitor to Kalydeco would need a solid safety profile as well.
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Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.