With Eylea (aflibercept) for wet age-related macular degeneration (AMD) ringing up global sales of $1.32 billion in the second quarter, handily above the $1.26 billion consensus estimate, Regeneron Pharmaceuticals Inc. fielded questions from analysts about the phase II effort testing the compound in AMD when combined with REGN2176-3, or rinucumab, a PDGF receptor-beta antibody.
CEO Leonard Schleifer pointed out during a conference call with investors that, "since this is a single injection of the two antibodies by the physician, we don't have to have [to show] a gigantic benefit. We just have to have something that's clearly beneficial. The hurdle for us to move forward isn't that great, because there's no additional burden on patients having to take an additional injection."
The two-stage study will run three separate arms of Eylea, Eylea plus low-dose rinucumab and Eylea plus high-dose rinucumab, and will measure improvements in visual acuity. Competitor Ophthotech Corp., of New York, is working on a combination therapeutic strategy to treat the disease. It has completed patient recruitment for its second phase III trial of Fovista (pegpleranib) in combination with Lucentis (ranibizumab, Roche AG) for wet AMD. The company said it expects to announce initial, top-line data from both phase III trials of Fovista in combination with Lucentis in the fourth quarter of this year. (See BioWorld Today, May 29, 2013.)
Tarrytown, N.Y.-based Regeneron reported total revenue 2 percent below consensus, with uptake of the PCSK9 inhibitor Praluent (alirocumab) for high cholesterol selling $24 million, just behind the same-class drug sold by competitor Amgen Inc., of Thousand Oaks, Calif.: Repatha (evolocumab), which sold $27 million during the period, though Leerink analyst Geoffrey Porges noted in a research report that, with the district court judge still to rule on Amgen's motion for a permanent injunction against Regeneron and Sanofi, Praluent's U.S. progress may be moot. Revenue for Regeneron totaled $1.21 billion, below the consensus guess of $1.24 billion. Income from the collaboration with Paris-based Sanofi SA lagged as well, reaching $163 million, 30 percent below the $233 million that Wall Street expected. Eylea chalked global sales of $1.32 billion, higher than the $1.26 billion consensus, Management reaffirmed financial guidance for the year for Eylea net U.S. revenue of about 20 percent to 25 percent over 2015. (See BioWorld Today, March 17, 2016.)
Piper Jaffray analyst Edward Tenthoff observed that "Praluent, sarilumab and dupilumab launch costs are hurting the Sanofi collaborative line and management increased both proprietary R&D and SG&A guidance." His firm expects approval of sarilumab in rheumatoid arthritis by the Oct. 30 PDUFA date and dupilumab in atopic dermatitis in the first half of next year. "We now estimate non-GAAP diluted earnings per share of $9.16 this year and $14.50 in 2017," he wrote in a research report, holding his neutral rating on the shares and raising the price target to $447 from $443.
Robert Terifay, Regeneron's vice president of commercial operations, said during the call that about 1.6 million patients in the U.S. with moderate to severe atopic dermatitis are uncontrolled on topical therapies. "A very small proportion of those patients have received other therapies, immunosuppressant agents, generally not biologics, but things like cyclosporine and methotrexate," he said. "The challenge with those therapies is you can't use them long term. They've got some toxicities that really interfere with the patient's long-term use of the therapy and, thus, their symptoms will come back, their itch will come back, and their quality of life will decrease. So there is a huge opportunity for dupilumab in these uncontrolled moderate to severe patients. There's a pent-up demand among patients and physicians to get the patients on therapy and to improve their lives."
Shares of Regeneron (NASDAQ:REGN) closed Thursday at $433.40, down $7.97
In other earnings news:
Alimera Sciences Inc., of Atlanta, disclosed that consolidated net revenue increased by $3.8 million, or 66 percent, to about $9.6 million, compared to net revenue of about $5.8 million for the same quarter last year. "This beat has shifted investors' focus from whether Alimera will avoid bankruptcy to what Iluvien's peak potential is," wrote Cowen and Co. analyst Boris Peaker in a research report. "While one good quarter does not guarantee future success, we believe the path to cash-flow break-even will remain investors' key focus." The company sells Iluvien (fluocinolone acetonide) for diabetic macular edema. Shares of Alimera (NASDAQ:ALIM) closed Thursday at $1.76, down 24 cents.
Amarin Corp. plc, of Dublin, reported revenue growth, recognizing $32.8 million in net product revenue from Vascepa (icosapent ethyl) to reduce triglyceride levels, compared to $17.7 million in the same quarter of last year, an increase of 85 percent. The company increased normalized prescriptions, based on data from Symphony Health Solutions and IMS Health, by 55 percent and 58 percent, respectively, compared to the period last year, reflecting the 10th consecutive quarter of greater than 50 percent growth in normalized prescriptions over the corresponding quarter in the prior year. The company also said it amended the cardiovascular outcomes trial REDUCE-IT special protocol assessment agreement (SPA) to include a second interim efficacy analysis at approximately 80 percent of targeted primary events and additional pre-specified secondary and tertiary endpoints while confirming FDA support for the key elements of the SPA agreement that were not amended. Shares of Amarin (NASDAQ:AMRN) closed Thursday at $3.28, down 4 cents.
Exelixis Inc., of South San Francisco, reported net revenues of $36.3 million, compared to $8 million for the comparable period in 2015. Included is $31.6 million of net product revenue compared to $8 million for the 2015 period, reflecting the impact of the commercial launch of Cabometyx (cabozantinib) for kidney cancer in late April 2016, as well as an increase in revenues from Cometriq. Net product revenues for Cabometyx and Cometriq (cabozantinib) for medullary thyroid cancer were $17.6 million and $14 million, respectively. Shares of Exelixis (NASDAQ:EXEL) gained $1.68, or 17.9 percent, to close Thursday at $11.07.
Intercept Pharmaceuticals Inc., of New York, reported a net loss of $77.3 million. GAAP operating expense was $83.6 million, and non-GAAP adjusted operating expense1 for the quarter was $78.5 million, which excludes noncash stock-based compensation expense of $4.3 million and depreciation expense of $900,000. The company recognized $75,000 of net sales of the primary biliary cholangitis drug Ocaliva (obeticholic acid), launched in June. Progress with Ocaliva was in line with expectations, the company said. Shares of Intercept (NASDAQ:ICPT) fell $9.38 Thursday to close at $163.21.
Progenics Pharmaceuticals Inc., of New York, reported a net loss of $5.6 million, or 8 cents per diluted share, compared to a net loss of $11.7 million, or 17 cents per diluted share in the 2015 period. Progenics ended the quarter with cash and cash equivalents of $60.1 million, a decrease of $5.5 million in the quarter. Revenue totaled $8.5 million, up from $1.9 million in 2015, reflecting royalty income from Relistor (methylnaltrexone bromide) for opioid-induced constipation of $2.4 million, compared to $1.8 million in the 2015 period, based on net sales reported to Progenics by Valeant Pharmaceuticals International Inc., of Laval, Quebec. The increase was primarily attributable to up-front and milestone revenue of $5 million under the license agreement with Bayer AG, of Leverkusen, Germany. Shares of Progenics (NASDAQ:PGNX) closed Thursday at $5.93, up 8 cents.