Genzyme http://www.so-l.ru/tags/show/genzyme Sun, 29 Mar 2020 23:52:08 +0300 <![CDATA[BioMarin Pharmaceutical (BMRN) Down 3.1% Since Earnings Report: Can It Rebound?]]> It has been about a month since the last earnings report for BioMarin Pharmaceutical Inc. BMRN. Shares have lost about 3.14 % in that time frame.

Will the recent negative trend continue leading up to its next earnings release, or is BMRN due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers.

BioMarin Fourth-Quarter Loss Wider, Sales Beat

BioMarin reported wider-than-expected loss in the fourth quarter of 2017 but beat estimates for sales.

Fourth-quarter loss of 30 cents per share was wider than the Zacks Consensus Estimate of a loss of 24 cents. However, the loss included a gain of $125 million on sale of the Priority Review Voucher (PRV) in December 2017. BioMarin was awarded the PRV when it was granted FDA approval for Brineura.

Excluding this one-time gain, provision for income taxes of $106 million and a contingent consideration expense, adjusted loss per share was 36 cents in the fourth quarter.

Total revenues came in at $358.3 million, up 19% from the year-ago quarter driven by higher product revenues. Revenues also topped the Zacks Consensus Estimate of $346 million.

Quarterly Details

Product revenues were $353.5 million in the quarter, up 19% year over year, supported by continued strong demand for BioMarin’s marketed products. Royalty and other revenues were $4.8 million in the fourth quarter, compared with $1.9 million in the year-ago quarter.

Kuvan revenues rose 19% to $107.4 million, reflecting patient growth in North America and solid uptake internationally. The number of patients on Kuvan therapy in the United States increased 7% in 2017.

Naglazyme sales rose 25% year over year to $93.8 million.

Vimizim contributed $114 million to total revenues, up 22% year over year and 26.2% sequentially. The drug continued to witness steady patient growth as the number of patients on Vimizim therapy increased 20% in 2017.

Naglazyme and Vimzim revenues vary on a quarterly basis, primarily due to the timing of central government orders from some countries, mainly Brazil.

A slowdown in federal purchasing orders in Brazil had hurt Naglazyme and Vimizim product revenues in the third quarter. However, BioMarin witnessed an uptick in Brazilian orders in the fourth quarter for both Naglazyme and Vimzim, which drove sales higher.

The company mentioned on the call that it is cautiously optimistic that sales in Brazil will be steady in 2018 but uneven buying patterns may be observed quarter to quarter.

BioMarin received Aldurazyme royalties – totalling $28.3 million (down 19%) – from Sanofi’s Genzyme in the quarter.

Brineura generated sales of $5.2 million in the fourth quarter compared with $3.1 million in the third quarter.

On the call, the company said that at 2017 end, 40 patients across 22 sites and 7 countries were receiving Brineura. Management expects to increase the number of sites to 40 by mid-2018

Management noted that the focus on the initial stages of launch is on disease awareness and early diagnosis The company mentioned that new site readiness can take longer than expected, which suggests slower revenue ramp up.

Regarding pegvaliase launch, management suggested that the initial sales ramp-up would be slow due to education on disease awareness and lower doses per patient in the induction titration phase.  Also, the company mentioned that it expects to price pegvaliase at a modest premium to Kuvan (net annual treatment cost of about $150,000).

Research and development (R&D) expenses declined 3.2% while selling, general and administrative (SG&A) expenses increased 14.6% in the quarter.

At the end of the 2017, BioMarin had $1.8 billion in cash, cash equivalents and investments compared with $1.4 billion at the end of the third quarter.

2017 Results

Full-year 2017 sales of $1.31 slightly beat the Zacks Consensus Estimate of $1.30 billion. Revenues were within the guidance of $1.29 −$1.32 billion. Sales rose 18% year over year.

Total revenues included a one-time upfront payment of $31.5 million received from Sarepta Therapeutics.

Reported loss of 67 cents per share was wider than the Zacks Consensus Estimate of a loss of 63 cents.

2018 Outlook

BioMarin expects total revenues in the range of $1.47 −$1.53 billion in 2018. This represents year-over-year growth of 15% to 19%, excluding the one-time Sarepta upfront payment.

The company mentioned on the call that though the guidance assumes the launch of pegvaliase in the United States in the second half of 2018, the range can still be met if pegvaliase launch is delayed.

Vimizim sales are expected in the range of $460–$500 million. Kuvan sales are projected in the range of $440–$480 million, an increase of about 13% from 2017. Naglazyme sales are projected in the range of $325−$355 million. Brineura sales are expected in the range of $35–$55 million.

Expenses related to R&D are expected within $645-$685 million while SG&A expenses are projected in the range of $575-$615 million.

The company expects adjusted net income in the range of $100 - $140 million, a 62% year-over-year improvement from the midpoint.

How Have Estimates Been Moving Since Then?

In the past month, investors have witnessed a downward trend in fresh estimates. There has been one revision higher for the current quarter compared to four lower.

VGM Scores

At this time, BMRN has an average Growth Score of C, though it is lagging a lot on the momentum front with an F. The stock was also allocated a grade of F on the value side, putting it in the lowest quintile for this investment strategy.

Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.

The company's stock is suitable solely for growth based on our styles scores.

Outlook

Estimates have been broadly trending downward for the stock and the magnitude of these revisions indicates a downward shift. Notably, BMRN has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.


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http://www.so-l.ru/news/y/2018_03_26_biomarin_pharmaceutical_bmrn_down_3_1 Mon, 26 Mar 2018 08:22:00 +0300
<![CDATA[Alnylam to advance lumasiran into late-stage development after Sanofi Genzyme backs away]]> http://www.so-l.ru/news/y/2018_03_12_alnylam_to_advance_lumasiran_into_late_s Mon, 12 Mar 2018 16:24:21 +0300 <![CDATA[Alnylam Pharmaceuticals (ALNY) Up 1.6% Since Earnings Report: Can It Continue?]]> It has been about a month since the last earnings report for Alnylam Pharmaceuticals, Inc. ALNY. Shares have added about 1.6% in that time frame.

Will the recent positive trend continue leading up to its next earnings release, or is ALNY due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers.

Alnylam's Q4 Earnings and Revenues Top Estimates

Alnylam incurred a loss of $1.20 per share in the fourth quarter of 2017, narrower than the Zacks Consensus Estimate of a loss of $1.38. However, the figure was wider than the year-ago loss of $1.08.

Quarterly revenues improved 116.6% to $37.9 million, which beat the Zacks Consensus Estimate of $26.9 million. The top line in the quarter included $13.4 million earned under the company's collaboration agreement with Sanofi’s subsidiary, Genzyme as well as $20.1 million from the company’s alliance with The Medicines Company and $4.4 million from other sources.

Quarter in Detail

Adjusted research and development (R&D) expenses increased 8.3% from the year-ago period to $102.9 million. Adjusted general and administrative (G&A) expenses more than doubled to $55.2 million.

2018 Guidance

Alnylam provided guidance for 2018. The company expects to end the year with approximately $1 billion in cash, cash equivalents and fixed income marketable. Adjusted R&D expenses are expected in the range of $400 million to $440 million while adjusted selling, general and administrative expenses are expected in the range of $280 million to $320 million.

Pipeline Updates

Alnylam reported positive phase III study results from the APOLLO study evaluating patisiran, an investigational RNAi therapeutic for the treatment of patients with hereditary ATTR (hATTR) amyloidosis with polyneuropathy. Based on these results, the company submitted a new drug application (“NDA”) for patisiran and a Marketing Authorization Application (“MAA”) during the quarter. Notably, it expects to receive approval by mid-2018.

Moreover, the company and its partner, The Medicines Company, commenced three phase III studies – ORION -9, -10, and -11 – on inclisiran, an investigational RNAi therapeutic targeting PCSK9 in development for the treatment of hypercholesterolemia in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).

During the quarter, the FDA lifted the temporary hold from phase III studies, evaluating fitusiran in patients with hemophilia An and B with or without inhibitors.

Alnylam announced restructuring of its rare disease alliance with Sanofi, following which the company gained global rights to patisiran and ALN-TTRsc02, while Sanofi obtained global rights to fitusiran.

How Have Estimates Been Moving Since Then?

In the past month, investors have witnessed a downward trend in fresh estimates. There have been two revisions lower for the current quarter. In the past month, the consensus estimate has shifted by 15.2% due to these changes.

Alnylam Pharmaceuticals, Inc. Price and Consensus

VGM Scores

At this time, ALNY has a poor Growth Score of F, however its Momentum is doing a lot better with an A. However, the stock was allocated a grade of D on the value side, putting it in the bottom 40% for this investment strategy.

Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.

The company's stock is suitable soley for momentum based on our styles scores.

Outlook

Estimates have been broadly trending downward for the stock and the magnitude of these revisions indicates a downward shift. It's no surprise ALNY has a Zacks Rank #4 (Sell). We expect a below average return from the stock in the next few months.


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http://www.so-l.ru/news/y/2018_03_12_alnylam_pharmaceuticals_alny_up_1_6_s Mon, 12 Mar 2018 12:40:00 +0300
<![CDATA[Henri Termeer’s legacy is a vibrant biotech sector]]> http://www.so-l.ru/news/y/2018_02_28_henri_termeer_s_legacy_is_a_vibrant_biot Wed, 28 Feb 2018 07:00:27 +0300 <![CDATA[BioMarin (BMRN) Q4 Loss Wider Than Expected, Sales Beat]]> BioMarin Pharmaceutical Inc. BMRN reported wider-than-expected loss in the fourth quarter of 2017 but beat estimates for sales.

Fourth-quarter loss of 30 cents per share was wider than the Zacks Consensus Estimate of a loss of 24 cents. However, the loss included a gain of $125 million on sale of the Priority Review Voucher (PRV) in December 2017. BioMarin was awarded the PRV when it was granted FDA approval for Brineura.

Excluding this one-time gain, provision for income taxes of $106 million and a contingent consideration expense, adjusted loss per share was 37 cents in the fourth quarter.

Total revenues came in at $358.3 million, up 19% from the year-ago quarter driven by higher product revenues. Revenues also topped the Zacks Consensus Estimate of $346 million.

In the past year, BioMarin’s shares have underperformed the industry. While BioMarin’s shares are down 4%, the industry has witnessed a decrease of 2.5%.

 

Quarterly Details

Product revenues were $353.5 million in the quarter, up 19% year over year, supported by continued strong demand for BioMarin’s marketed products. Royalty and other revenues were $4.8 million in the fourth quarter, compared with $1.9 million in the year-ago quarter.

Kuvan revenues rose 19% to $107.4 million, reflecting patient growth in North America and solid uptake internationally. The number of patients on Kuvan therapy in the United States increased 7% in 2017.

Naglazyme sales rose 25% year over year to $93.8 million.

Vimizim contributed $114 million to total revenues, up 22% year over year and 26.2% sequentially. The drug continued to witness steady patient growth as the number of patients on Vimizim therapy increased 20% in 2017.

Naglazyme and Vimzim revenues vary on a quarterly basis, primarily due to the timing of central government orders from some countries, mainly Brazil.

A slowdown in federal purchasing orders in Brazil had hurt Naglazyme and Vimizim product revenues in the third quarter. However, BioMarin witnessed an uptick in Brazilian orders in the fourth quarter for both Naglazyme and Vimzim, which drove sales higher.

BioMarin received Aldurazyme royalties – totaling $57.5 million (up 5%) – from Sanofi’s SNY Genzyme in the quarter.

The newest drug in BioMarin’s portfolio, Brineura, generated sales of $5.2 million in the fourth quarter compared with $3.1 million in the third quarter. Brineura received approval for the treatment of children with CLN2 disease – a form of Batten disease – both in the United States and the EU in the first half of 2017. Its commercial launch is underway in the United Statesand EU.

On the call, the company said the initial Brineura launch is rolling out as anticipated. However, the company mentioned that new site readiness can take longer than expected due to the complexity of planning for surgery and infusions within hospitals.

Research and development (R&D) expenses declined 3.2% while selling, general and administrative (SG&A) expenses increased 14.6% in the quarter.

At the end of the 2017, BioMarin had $1.8billion in cash, cash equivalents and investments versus $1.4 billion at the end of the third quarter.

2017 Results

Full-year 2017 sales of $1.31 slightly beat the Zacks Consensus Estimate of $1.30 billion. Revenues were within the guidance of $1.29 −$1.32 billion. Sales rose 18% year over year.

Total revenues included aone-time upfront payment of $31.5 million received from Sarepta Therapeutics, Inc. SRPT. In July last year, BioMarin entered into a license and settlement agreement with Sarepta resolving the exon-skipping patent litigation.

Reported loss of 67 cents per share was wider than the Zacks Consensus Estimate of a loss of 63 cents.

Pipeline Update

Regarding pegvaliase, which has been developed to treat phenylketonuria (PKU), the company plans to submit a marketing application in Europe in the first quarter of 2018. In the United States, pegvaliase biologics license application (BLA) is currently under priority review with the FDA expected to give its decision May this year.

Meanwhile, BioMarin has launched two separate phase III studies on valoctocogene roxaparvovec, its investigational gene therapy for severe hemophilia A. While one of these (GENEr8–1 study) was initiated last December, the other one (GENEr8–2) will start early this year.

Meanwhile, the global phase III program on another candidate, vosoritide for the treatment of children (ages 5-14) with achondroplasia (the most common form of dwarfism) continues to enrol as planned with study completion expected by mid-year.

2018 Outlook

BioMarin expects total revenues in the range of $1.47 −$1.53 billion in 2018. This represents year-over-year growth of 15% to 19%, excluding the one-time Sarepta upfront payment. The Zacks Consensus Estimate is pegged at $1.48 billion.

The company mentioned on the call that though the guidance assumes the launch of pegvaliase in the United States in the second half of 2018, the range can still be achieved without pegvaliase.

Vimizim sales are expected in the range of $460–$500 million. Kuvan sales are projected in the range of $440–$480 million, an increase of about 13% from 2017. Naglazyme sales are projected in the range of $325−$355 million. Brineura sales are expected in the range of $35–$55 million

Expenses related to R&D are expected within $645-$685 million while SG&A expenses are projected in the range of $575-$615 million.

The company expects adjusted net income in the range of $100 - $140 million.

BioMarin carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Regeneron Pharmaceuticals, Inc. REGN with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have risen over 8.7% for 2018 and 5.4% for 2019 over the last 30 days. The company delivered an average four-quarter positive surprise of 9.15%.

BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise

 

BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise | BioMarin Pharmaceutical Inc. Quote

 

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http://www.so-l.ru/news/y/2018_02_23_biomarin_bmrn_q4_loss_wider_than_expec Fri, 23 Feb 2018 17:12:00 +0300
<![CDATA[Alnylam's (ALNY) Q4 Earnings and Revenues Top Estimates]]> Alnylam Pharmaceuticals, Inc. ALNY incurred a loss of $1.20 per share in the fourth quarter of 2017, narrower than the Zacks Consensus Estimate of a loss of $1.38. However, the figure was wider than the year-ago loss of $1.08.

Quarterly revenues improved 116.6% to $37.9 million, which beat the Zacks Consensus Estimate of $26.9 million. The top line in the quarter included $13.4 million earned under the company's collaboration agreement with Sanofi’s SNY subsidiary, Genzyme as well as $20.1 million from the company’s alliance with The Medicines Company MDCO and $4.4 million from other sources.

Quarter in Detail

Adjusted research and development (R&D) expenses increased 8.3% from the year-ago period to $102.9 million. Adjusted general and administrative (G&A) expenses more than doubled to $55.2 million.

2018 Guidance

Alnylam provided guidance for 2018. The company expects to end the year with approximately $1 billion in cash, cash equivalents and fixed income marketable. Adjusted R&D expenses are expected in the range of $400 million to $440 million while adjusted selling, general and administrative expenses are expected in the range of $280 million to $320 million.

Pipeline Updates

Alnylam reported positive phase III study results from the APOLLO study evaluating patisiran, an investigational RNAi therapeutic for the treatment of patients with hereditary ATTR (hATTR) amyloidosis with polyneuropathy. Based on these results, the company submitted a new drug application (“NDA”) for patisiran and a Marketing Authorization Application (“MAA”) during the quarter. Notably, it expects to receive approval by mid-2018.

Moreover, the company and its partner, The Medicines Company, commenced three phase III studies – ORION -9, -10, and -11 – on inclisiran, an investigational RNAi therapeutic targeting PCSK9 in development for the treatment of hypercholesterolemia in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).

During the quarter, the FDA lifted the temporary hold from phase III studies, evaluating fitusiran in patients with hemophilia A and B with or without inhibitors.

Alnylam announced restructuring of its rare disease alliance with Sanofi, following which the company gained global rights to patisiran and ALN-TTRsc02, while Sanofi obtained global rights to fitusiran.

Our Take

Alnylam beat estimates on both counts in the fourth quarter. With several pipeline related events lined up and potential approval for patisiran, we expect investor focus to remain on  the related updates.

Shares rose over 1.4% in after-hours trading in response to the strong quarterly results. In the past year, Alnylam’s share price has increased a massive 158.7%, against a 3.3% decline for the industry.

Zacks Rank & Stock to Consider

Alnylam carries a Zacks Rank #3 (Hold). A better-ranked health care stock in the same space is Exelixis, Inc. EXEL, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Exelixis’ earnings per share estimates have moved up from 73 cents to 77 cents for 2018 over the last 30 days. The company pulled off positive earnings surprises in each of the trailing four quarters, with an average beat of 572.92%. The share price of the company has increased 22.6% in the past year.

Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

 

Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise | Alnylam Pharmaceuticals, Inc. Quote

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http://www.so-l.ru/news/y/2018_02_09_alnylam_s_alny_q4_earnings_and_revenue Fri, 09 Feb 2018 17:54:00 +0300
<![CDATA[Sanofi (SNY) Q4 Earnings Lag on Weak Diabetes/Vaccines Sales]]> Sanofi SNY reported fourth-quarter 2017 earnings of 63 cents per American depositary share, which missed the Zacks Consensus Estimate of 69 cents. Earnings declined 15.2% on a reported basis. At constant currency rates (CER), earnings declined 8.8%.

Fourth-quarter net sales declined 2% on a reported basis to almost $10.26 billion (€8.69 billion). Sales also missed the Zacks Consensus Estimate of $10.38 billion. Unfavorable exchange rate movements hurt sales by 6.1%. At CER, sales rose 4.1% year over year.          

In January 2017, the French drug maker swapped its Merial Animal Health businesses with Boehringer Ingelheim’s Consumer Healthcare (CHC) business. Reflecting this exchange and full consolidation of Sanofi’s European vaccines operations, sales declined 1.6% at constant structure (CS) and CER basis.

Sales declined 6.2% at CER in the United States. However, sales rose 6.3% in Emerging Markets, 15.8% in Europe and 8.3% in the Rest of the World (Japan, South Korea, Canada, Australia, New Zealand and Puerto Rico).

All growth rates mentioned below are on a year-on-year basis and at CER.

Segmental Performance

Pharmaceuticals sales (including emerging markets) declined 2.8% to €7.3 billion. However, at CS and CER, Pharmaceuticals sales rose 4%.

Sanofi reports through five Global Business Units (GBUs) – Sanofi Genzyme (Specialty Care), Diabetes & Cardiovascular, General Medicines & Emerging Markets, Consumer Healthcare and Sanofi Pasteur (Vaccines).

Sanofi Genzyme/Specialty Care GBU sales (including emerging markets) increased 16.5% to €1.71 billion, driven by contribution from new immunology drugs – Dupixent and Kevzara - and higher sales of multiple sclerosis (MS) and rare disease drugs.

Sales of MS drugs Aubagio rose 13.6% to €389 million while sales of Lemtrada went up 0.9% to €112 million.

Meanwhile, sales of rare disease drugs like Myozyme/Lumizyme improved 11.5% to €205 million while Fabrazyme sales were €180 million, up 6%. Cerdelga sales came in at €33 million, up 20.7% while Cerezyme sales rose 7.1% to €183 million.

Oncology sales rose 3.5% to €361 million. Jevtana sales were up 14.1% to €99 million while Thymoglobulin recorded sales of €72, flat year over year. Taxotere sales were also flat at €40 million. Eloxatine sales were up 14.6% to €44 million.

Sanofi and Regeneron Pharmaceuticals, Inc.’s REGN rheumatoid arthritis (RA) drug Kevzara (sarilumab) was launched in the United States in June 2017 and in United Kingdom, Netherlands and Germany in Europe in the second half.  Kevzara recorded sales of €8 million in the quarter compared with €2 million in the previous quarter.

Meanwhile, Dupixent/dupilumab for treating atopic dermatitis was launched in the United States in March and approved in the EU in September 2017. In December, Sanofi launched Dupixent in Germany. Dupixent generated sales of €118 million in the fourth quarter compared with €75 million in the previous quarter. Kevzara and Dupixent generated total immunology sales of €126 million in the fourth quarter, much higher than €77 million in the previous quarter.

Diabetes and Cardiovascular GBU (including emerging markets) declined 14.2% to €1.66 billion. The Diabetes franchise (including emerging markets) declined 15.6% to €1.53 billion due to lower sales of key drug Lantus.

Sales of diabetes drugs in the United States declined 29.5% to €730 million due to a tough U.S. payer environment and difficult year-over-year comparisons. Sales of diabetes drugs in Emerging Markets were up 8.2% while in Europe it rose 1.3%.

Lantus sales declined 20.9% to €1.08 billion in the quarter. Lantus sales declined 31.4% in the United States due to lower average net price and exclusion from the CVS and United Health formulary plans while in Europe sales declined 7.5% due to biosimilar competition and patient switching to Toujeo.

Toujeo generated sales of €216 million in the reported quarter, which, though down 4.2% on a year-over-year basis due to difficult year-ago comparisons, rose 9% sequentially.

Soliqua, a once-daily titratable fixed-ratio combination of Lantus and Lyxumia, was launched in the United States in January 2017 and in some European countries (trade name – Suliqua) in 2017. Soliqua/Suliqua generated sales of €9 million in the quarter compared with €8 million in the previous quarter.

In the cardiovascular franchise, Sanofi’s anti PCSK9 therapy, Praluent garnered worldwide sales of €53 million in the reported quarter, compared with €42 million in the previous quarter.

General Medicines & Emerging Markets GBU sales came in at €3.35 billion, down 2.3%. Sales of Established products were €2.3 billion, down 5.5% as strong performance in emerging markets was offset by lower sales in Europe and generic competition for Plavix in Japan and Renvela/Renagel in the United States.

Sales of Generics declined 2.1% to €435 million due to lower sales in Europe and Emerging Markets.

Consumer Healthcare GBU sales were €1.2 billion, up 51.8%. Sales were up 2.5%, excluding acquisition of Boehringer Ingelheim’s Consumer Healthcare business, driven by higher sales in Europe and United States, which offset slight decline in Emerging Markets.

Fourth-quarter consolidated Sanofi Pasteur (Vaccines) sales increased 8.7% to €1.39 billion. Vaccines sales reflect the termination of the Sanofi Pasteur MSD joint venture with Merck MRK in Europe from December 2016.

In the Vaccines segment, lower sales in Emerging Markets and United States offset sales growth in Europe. In Emerging Markets, vaccines sales declined due to the phasing effect of Hexaxim pediatric vaccine sales and the buyback of unused doses of Sanofi’s dengue vaccine, Dengvaxia following the unfavorable label update announced in November.

Sanofi is facing issues with Dengvaxia due to safety concerns. In November, Sanofi had revealed that in people who had never been infected by the dengue virus, vaccination with Dengvaxia, upon a subsequent dengue infection, might increase the risk of severe disease. 

In response, in December 2017, the Philippines FDA asked the company to suspend the sale/distribution/marketing of Dengvaxia and withdraw it from the market pending compliance with the directives of the agency.

In the United States, lower sales of pediatric and booster vaccines resulted in a decline.

Costs Rise

Selling general and administrative expenses (SG&A) increased 9.6% at CER in the quarter, reflecting launch costs of Dupixent and Kevzara and additional costs in China. R&D expenses were up 6.3% at CER, reflecting higher pipeline development costs in oncology (isatixumab, PD-1) and sotagliflozin.

Full Year 2017 Results

Full-year 2017 earnings of $3.13 per American depositary share also missed the Zacks Consensus Estimate of $3.34 per share. Earnings declined 2.5% on a reported basis. At CER, earnings declined 0.2%, which was almost in line with Sanofi’s expectation of it remaining more or less flat on a CER basis

Net sales rose 3.6% on a reported basis and 5.6% at CER to almost $39.6 billion (€35.06 billion). Sales, however, missed the Zacks Consensus Estimate of $42.3 billion.

2018 Outlook

Sanofi expects 2018 business earnings to grow between 2% and 5% at CER. It anticipates a negative currency impact in the range of 3%-4% on business earnings in 2018. However, the guidance includes the impact of the recently announced pending acquisitions of Belgian   nanobodies maker, Ablynx and a small biotech focused on making therapies for hemophilia, Bioverativ Inc. BIVV. The acquisitions should strengthen Sanofi’s position in the rare blood disorders market.

Our Take

Sanofi’s fourth-quarter 2017 results were below expectations as it missed estimates for both earnings and sales.

Higher sales of multiple sclerosis and rare disease drugs, significant contribution from Dupixent and a strong performance in Europe was offset by continued weakness in the Diabetes franchise and lower vaccine sales in Emerging Markets and United States. Shares of Sanofi were down more than 2% in pre-market trading.

In the past year, Sanofi’s shares have returned 2.2%, underperforming the 14.4% increase for the industry.

However, Sanofi’s 2018 outlook looks upbeat as it expects to return to growth this year on the back of the Bioverativ and Ablynx deals, a strong pipeline and lower tax rates under the new tax laws.

Sanofi carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sanofi Price, Consensus and EPS Surprise

 

Sanofi Price, Consensus and EPS Surprise | Sanofi Quote

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http://www.so-l.ru/news/y/2018_02_07_sanofi_sny_q4_earnings_lag_on_weak_dia Wed, 07 Feb 2018 18:43:00 +0300
<![CDATA[Alnylam's (ALNY) Q3 Earnings, Revenues Miss Estimates]]> Alnylam Pharmaceuticals, Inc. ALNY incurred a loss of $1.34 per share in the third quarter of 2017, wider than the Zacks Consensus Estimate of a loss of $1.23. The figure was also wider than the year-ago loss of $1.21.

Quarterly revenues improved 25.2% to 17.1 million. However, the same missed the Zacks Consensus Estimate of $37 million. The top line in the quarter included $14.6 million earned under the company's collaboration agreement with Sanofi’s SNY subsidiary, Genzyme as well as $2.3 million from the company’s alliance with The Medicines Company MDCO and $0.2 million from other sources.

So far this year, Alnylam’s stock has increased 245.8% compared with the industry’s growth of  3.3%.

Quarter in Detail

Research and development expenses declined 2.7% from the year-ago period to $95.3 million. However, general and administrative expenses more than doubled to $47.6 million.

Guidance

Alnylam remains on track to end 2017 with greater than $1 billion in cash, cash equivalents and fixed income marketable securities including $150 million in restricted investments.

Pipeline Updates

Alnylam reported positive phase III study results from the APOLLO study evaluating patisiran an investigational RNAi therapeutic for the treatment of patients with hereditary ATTR (hATTR) amyloidosis with polyneuropathy. Based on these results, the company plans to submit a new drug application (NDA) for patisiran by the end of 2017 and a Marketing Authorization Application (MAA) thereafter. Notably, it expects to receive approval by mid 2018.

Alnylam initiated the ENVISION phase III program for givosiran in acute hepatic porphyrias as well.

Moreover, the company and its partner, The Medicines Company, commenced the ORION-11 phase III study of inclisiran, an investigational RNAi therapeutic targeting PCSK9 in development for the treatment of hypercholesterolemia, in patients with atherosclerotic cardiovascular disease (ASCVD).

Again, the company initiated the ATLAS phase III study to evaluate the safety and efficacy of fitusiran in patients with hemophilia A and B with or without inhibitors.

Meanwhile, Alnylam suspended dosing in all ongoing studies of fitusiran temporarily. This was due to a fatal thrombotic serious adverse event that occurred in a patient with hemophilia A without inhibitors who was receiving fitusiran in the phase II OLE study. It plans to resume dosing in all studies as soon as possible, potentially by the end of 2017.

Our Take

Alnylam’s reported wider-than-expected loss and sales miss in the third quarter. With several pipeline-related events lined up for the upcoming quarters, we expect investor’s focus to remain on further updates by the company.

Zacks Rank & Key Pick

Alnylam carries a Zacks Rank #3 (Hold). A better-ranked health care stock in the same space is Ligand Pharmaceuticals Inc. LGND sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have moved up $3.68 to $3.70 for 2018 over the last 30 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 6.19%. The share price of the company has increased 44% year to date.

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http://www.so-l.ru/news/y/2017_11_08_alnylam_s_alny_q3_earnings_revenues_m Wed, 08 Nov 2017 19:47:00 +0300
<![CDATA[Sanofi (SNY) Q3 Earnings In Line, Sales Lag, Diabetes Weak]]> Sanofi SNY reported third-quarter 2017 earnings of $1.00 per American depositary share, which were in line with the Zacks Consensus Estimate. Earnings declined 4.5% on a reported basis. However at constant currency rates (CER), earnings rose 1.1%.

Third-quarter net sales rose 0.3% on a reported basis and 4.7% at CER to almost $10.59 billion (€8.05 billion). Sales, however, missed the Zacks Consensus Estimate of $10.93 billion. Unfavorable exchange rate movements hurt sales by 4.4%.

In January 2017, the French drug maker swapped its Merial Animal Health businesses with Boehringer Ingelheim’s Consumer Healthcare (CHC) business. Reflecting this exchange and full consolidation of Sanofi’s European vaccines operations, sales declined 0.2% at constant structure (CS) and CER.

Sales declined 2.4% at CER in the United States. However, sales rose 11.4% in Emerging Markets, 8.2% in Europe and 9.1% in the Rest of the World (Japan, South Korea, Canada, Australia, New Zealand, Puerto Rico).

All growth rates mentioned below are on a year-on-year basis and at CER.

Segmental Performance

Pharmaceuticals sales (including emerging markets) increased 3.2% to €7.14 billion. However, at CS and CER, Pharmaceuticals sales declined 1.2% as double-digit growth of multiple sclerosis drugs and vaccines franchises and robust growth in emerging markets was offset by a decline in diabetes, established products and generics sales.

Sanofi reports through five Global Business Units (GBUs) – Sanofi Genzyme (Specialty Care), Diabetes & Cardiovascular, General Medicines & Emerging Markets, Consumer Healthcare and Sanofi Pasteur (Vaccines).

Sanofi Genzyme/Specialty Care GBU sales (including emerging markets) increased 12.5% to €1.63 billion, driven by strong U.S. launch of Dupixent and higher sales of multiple sclerosis (MS) drugs.

Sales of MS drugs Aubagio rose 19.2% to €382 million while sales of Lemtrada went up 5.4% to €113 million. However, sales of both these drugs declined sequentially in the quarter.

Meanwhile, sales of rare disease drugs like Myozyme/Lumizyme improved 5.9% to €191 million while Fabrazyme sales were €175 million, up 4.5%. Cerdelga sales came in at €31 million, up 14.3% while Cerezyme sales rose 1.6% to €178 million.

Oncology sales rose 5% to €363 million driven mainly by higher sales of Jevtana and Thymoglobulin. Jevtana sales were up 6.8% to €90 million while Thymoglobulin recorded sales of €71, up 5.7%. Taxotere sales rose 2.2% to €42 million. Eloxatine sales were up 11.6% to €45 million.

Sanofi and Regeneron Pharmaceuticals, Inc.’s REGN rheumatoid arthritis (RA) drug Kevzara (sarilumab) was launched in the United States in June and in Netherlands and Germany in Europe in the third quarter.  Kevzara recorded sales of €2 million in the third quarter compared with €1 million in the previous quarter.

Meanwhile, Dupixent/dupilumab for treating atopic dermatitis was launched in the United States in March. Dupixent generated sales of €75 million in the third quarter compared with €26 million in the previous quarter. Management is pleased with the drug’s uptake and said that in the United States, the drug has been prescribed by over 7,100 physicians. Meanwhile, Dupixent was approved in the EU in September and is expected to be launched in Germany by the end of this year. Kevzara and Dupixent generated total immunology sales of €77 million in the third quarter.

Diabetes and Cardiovascular GBU (including emerging markets) declined 9.1% to €1.68 billion. The Diabetes franchise (including emerging markets) declined 10% to €1.55 billion due to lower sales of key drug Lantus.

Sales of diabetes drugs in the United States declined 22.4% to €725 million due to a tough U.S. payer environment. Sales of diabetes drugs in Emerging Markets were up 17.3% while in Europe it declined 3.1%.

Lantus sales declined 15.5% to €1.12 billion in the quarter. Lantus sales declined 25.4% in the United States due to lower average net price and exclusion from the CVS and United Health formulary plans while Europe sales declined 14% due to biosimilar competition and patient switching to Toujeo.

Toujeo generated sales of €198 million in the reported quarter, which, though up 23.4% on a year-over-year basis, declined 5.7% sequentially.

Soliqua, a once-daily titratable fixed-ratio combination of Lantus and Lyxumia, was launched in the United States in January and in Netherlands (trade name – Suliqua) recently. Soliqua/Suliqua generated sales of €8 million in the quarter compared with €5 million in the previous quarter.

Management warned that U.S. diabetes franchise sales will decline at an accelerated rate in the fourth quarter due to CVS/United Health formulary exclusion plans and difficult comparisons with the last year. Considering recent market trends, Sanofi now expects its global Diabetes sales to decline in the range of 6–8% CAGR over the 2015–2018 timeframe. Previously, Sanofi had guided sales decline in the range of 4% to 8%.

In the cardiovascular franchise, Sanofi’s anti PCSK9 therapy, Praluent garnered worldwide sales of €42 million in the reported quarter, flat sequentially. Incidentally, Amgen AMGN, which reported last week, also did not report a very significant sequential improvement in sales of its PCSK9 inhibitor, Repatha. Uptake of these drugs has not been very encouraging so far due to pricing and re-imbursement issues/payer restrictions.

General Medicines & Emerging Markets GBU sales came in at €3.31 billion, down 2.7%. Sales of Established products were €2.26 billion, down 6.5% as strong performance in emerging markets was offset by lower sales in Europe and generic competition for Plavix in Japan and Renvela/Renagel in the United States.

Sales of Generics declined 0.9% to €433 million due to lower sales in Europe. Consumer Healthcare GBU sales were €1.13 billion, up 48.5%. However, sales were up only 1% excluding acquisition of Boehringer Ingelheim’s Consumer Healthcare business due to increased competition in developed markets.

Third-quarter consolidated Sanofi Pasteur (Vaccines) sales increased 11% to €1.92 billion due to the strong performance of pediatric combinations and booster vaccine, Menactra. Vaccines sales reflect the termination of the Sanofi Pasteur MSD joint-venture with Merck MRK in Europe from December 2016.

Costs Rise

Selling general and administrative expenses (SG&A) increased 5.9% at CER in the quarter, reflecting launch costs of Dupixent and Kevzara. R&D expenses were up 12.9% at CER, reflecting higher pipeline development costs in oncology (isatixumab, PD-1) and sotagliflozin.

2017 Outlook

Sanofi maintained its previously issued financial outlook.

Sanofi expects 2017 business earnings to be broadly flat at CER. It anticipates a negative currency impact in the range of 1%-2% on business earnings in 2017. This compares unfavorably with the prior expectations of a positive currency impact of 1%.

Our Take

Sanofi’s third-quarter 2017 results mixed as it reported in-line earnings and missed sales expectations. Strong performances of multiple sclerosis and vaccines franchises, successful launch of Dupixent and robust emerging market sales could not make up for the weak performance in the diabetes and cardiovascular unit. Shares of Sanofi  were down slightly more than 1% in pre-market trading.

So far this year, Sanofi’s share price has risen 14.9%, slightly worse than a 15.1% increase for the industry.

However, despite greater-than-previously expected headwinds from currency, the company maintained its earnings forecast, which was encouraging.

We are encouraged by the strong performance of MS drugs like Aubagio and Lemtrada. We are also optimistic on sales prospects of Dupixent, which could prove to be an important growth driver for the company.

However, headwinds include a bleak outlook for the Diabetes franchise, generic competition for many drugs and slower-than-expected uptake of new products like Praluent.

Sanofi Price, Consensus and EPS Surprise

 

Sanofi Price, Consensus and EPS Surprise | Sanofi Quote

Sanofi currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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http://www.so-l.ru/news/y/2017_11_02_sanofi_sny_q3_earnings_in_line_sales Thu, 02 Nov 2017 16:34:00 +0300
<![CDATA[Voyager down 7% on Genzyme exit from Parkinson's gene therapy program]]> http://www.so-l.ru/news/y/2017_10_31_voyager_down_7_on_genzyme_exit_from_par Tue, 31 Oct 2017 22:41:09 +0300 <![CDATA[BioMarin (BMRN) Q3 Loss Narrows, Profit Guidance Raised]]> BioMarin Pharmaceutical Inc. BMRN reported narrower-than-expected loss in the third quarter of 2017 but missed estimates for sales. The biotech also raised its previously issued adjusted net income guidance for 2017.

So far this year, BioMarin’s shares have underperformed the industry. While BioMarin’s shares are down 0.4%, the industry has witnessed an increase of 3.7%.

Loss Narrower than Expected

Third-quarter loss of 7 cents per share was narrower than the Zacks Consensus Estimate of a loss of 13 cents as well as the year-ago loss of 22 cents. A one-time upfront payment received from Sarepta Therapeutics, Inc. SRPT primarily led to the narrower loss in the quarter. In July, BioMarin entered into a license and settlement agreement with Sarepta resolving the exon-skipping patent litigation. Excluding this one-time upfront payment of $31.5 million and a contingent consideration gain, adjusted loss per share was 27 cents in the third quarter.

Sales Miss

Total revenue came in at $334.1 million, up 19% from the year-ago quarter. Revenues, however, missed the Zacks Consensus Estimate of $348 million.

Quarterly Details

Product revenues were $298.8 million in the quarter, up 7% year over year.

Kuvan revenues rose 16% to $105.8 million, reflecting patient growth in North America and continued growth in the ex-North American territories acquired in 2016. The number of patients on Kuvan therapy in the United States increased 9% in the third quarter.

Naglazyme sales declined 7% year over year to $72.1 million.

Vimizim contributed $90.3 million to total revenue, up 12% year over year. However, Vimizim sales declined 12.5% sequentially.

Naglazyme and Vimzim revenues vary on a quarterly basis, primarily due to the timing of central government orders from some countries, mainly Brazil.

Earlier this month, at its R&D day, BioMarin had said that a slowdown in federal purchasing orders in Brazil have hurt Naglazyme and Vimizim product revenues in the third quarter.

Moreover, at that time, BioMarin had said that if the slowdown continues in the fourth quarter, it will only be able to meet the lower end of the total product revenue guidance ($1.25 billion and $1.3 billion, not including milestone payment from Sarepta). However, in the earnings release, BioMarin said that since the R&D day, the Brazilian Ministry of Health has initiated a purchasing process and it expects 2017 revenues to be within the guidance.

BioMarin received Aldurazyme royalties – totaling $22.4 million (down 5%) – from Sanofi’s SNY Genzyme in the quarter.

Brineura received approval for the treatment of children with CLN2 disease – a form of Batten disease – both in the United States and the EU in the second quarter. The newest drug in BioMarin’s portfolio generated sales of $3.1 million in the third quarter compared to $0.3 million in the second quarter. The company said the worldwide launch of Brineura was in-line with expectations and it achieved sales in the United States and in the European countries of Germany, France, Italy and Argentina.

Research and development (R&D) expenses declined 4.2% owning to lower spending on the Brineura program and the discontinuance of the Kyndrisa program last year. Selling, general and administrative (SG&A) expenses increased 9.8% primarily due to increased expenses related to the acquisition of international Kuvan rights, costs associated with the Brineura launch and higher stock compensation expenses.

Pipeline Update

Regarding pegvaliase, which has been developed to treat phenylketonuria (PKU), the company plans to submit a marketing application in Europe in the first quarter of 2018, slightly delayed from the end of 2017 as guided previously. In the United States, pegvaliase Biologics License Application (BLA) is currently under priority review. Last month, BioMarin announced that the FDA is not looking to hold an advisory panel meeting for the company’s BLA for pegvaliase. Earlier this month, the company said the FDA is expected to give its decision in the first half of 2018.

Meanwhile, two phase III studies (one in high dose (6e13 vg/kg) and one in mid dose (4e13 vg/kg)) on its hemophilia A candidate valoctocogene roxaparvovec (formerly BMN 270) are expected to be initiated before the end of the year. Concurrent with the earnings release, BioMarin announced that the FDA has granted Breakthrough Therapy Designation to valoctocogene roxaparvovec based on positive data from phase I/II study.

Earlier this month, BioMarin also announced that it has selected BMN 290, a small molecule drug, as its next development candidate. BMN 290 will be evaluated for the treatment of Friedreich's Ataxia (FA), a rare autosomal recessive disorder for which no disease modifying therapies are currently approved. An Investigational New Drug (IND) application to begin phase I studies is expected to be submitted in the second half of next year.

2017 Outlook

The company tightened its previously issued 2017 sales guidance. However, it raised its adjusted earnings guidance while lowering its expectations for operating costs.

BioMarin expects total revenue in the range of $1.29 −$1.32 billion (including milestone payment from Sarepta) compared with $1.285 −$1.335 billion previously.  This represents year-over-year growth of 15.5% to 18.2%.

Vimizim sales are expected in the range of $400–$420 million (previously $400–$430 million). Kuvan sales are projected in the range of $400–$420 million (previously $380−$410 million). Naglazyme sales are projected in the range of $310−$330 million (previously $300−$330 million).

Expenses related to R&D are expected within $600-$620 million, down from $610-$640 million while SG&A expenses are projected in the range of $530-$550 million, compared with $530-$560 million previously.

The bottom line, on an adjusted basis, is expected to turn positive in 2017. The company raised its 2017 adjusted net income guidance from $30 - $70 million to $60 - $80 million. Meanwhile, management is committed to profitability improvements over the longer term.

At the call, BioMarin also said it expects its present marketed products plus pegvaliase to drive the top line at a 15% compounded rate through 2020 while costs will rise at a lower level.

BioMarin carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Amgen, Inc. AMGN with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Amgen’s earnings estimates have risen over 1% in 2017 and 0.7% in 2018 over the last 30 days. The company delivered an average four-quarter positive surprise of 5.25%. Shares have risen 20.7% so far this year.

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http://www.so-l.ru/news/y/2017_10_27_biomarin_bmrn_q3_loss_narrows_profit Fri, 27 Oct 2017 18:30:00 +0300
<![CDATA[Keryx Focuses on Kidney Drug Auryxia Despite Generic Threat]]> We issued an updated research report on Keryx Biopharmaceuticals, Inc. KERX on Sep 26, 2017.

Notably, the company’s only marketed product, Auryxia (ferric citrate) is approved in the United States for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

In the second quarter of 2017, net sales of Auryxia in the United States were $14.1 million, up 71% following strong prescription growth. In fact, a total of 21,100 prescriptions were written in the reported quarter, up 61% year over year. Also, Auryxia was added to Medicare Part D drug list at two of the largest Medicare Part D insurance providers, which will give the drug unrestricted access to approximately 95% of phosphate binder patients.

Currently, Keryx is working on expanding Auryxia's label to include the treatment of iron deficiency anemia (IDA) in adults with stage III–V non-dialysis dependent (NDD) CKD. In March 2017, the FDA accepted the company’s supplemental New Drug Application (sNDA) for Auryxia for review and gave a Prescription Drug User Fee Act (PDUFA) target action date of Nov 6, 2017. A potential approval is expected to significantly boost sales of Auryxia.

Meanwhile, the company is looking for potential partners to commercialize the drug in the EU. Ferric citrate (the compound name for Auryxia for additional indications) has been considered as a new active substance by the European Commission. This provides it with 10 years of data and marketing exclusivity in the region.

However, Auryxia faces stiff competition in the United States from existing players. Apart from over-the-counter drugs like some calcium carbonate and metal-based products including aluminum and magnesium, Sanofi’s SNY specialty medicines arm, Genzyme Renagel and Renvela, Shire plc’s SHPG Fosrenol, and Fresenius Medical Care’s FMS PhosLo and Velphoro are already available in the market.

Since Auryxia is in early stages of commercialization, we believe the company may face a tough time gaining share.

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http://www.so-l.ru/news/y/2017_09_29_keryx_focuses_on_kidney_drug_auryxia_des Fri, 29 Sep 2017 16:13:00 +0300
<![CDATA[Sanofi Rides on Genzyme & Vaccines Unit, Diabetes Sales Weak]]> We issued an updated research on Sanofi, Inc. SNY on Sep 26.

Sanofi performed quite well in the first half of 2017. Earnings rose4.9% on a reported basis in the first half of 2017 and 2.7% at constant currency rates (CER) on a year-over-year basis.

First halfnet sales rose 8.7% on a reported basis and 5.5% at CER.  In January 2017, Sanofi swapped its Merial Animal Health businesses with Boehringer Ingelheim’s Consumer Healthcare (CHC) business. Reflecting this exchange and full consolidation of Sanofi’s European vaccines operations, sales rose 2% at constant structure and CER. We remind investors that Sanofi terminated its Sanofi Pasteur MSD joint venture with Merck & Co., Inc. MRK in Europe in December last year.

A strong performance by Genzyme’s Specialty Care (Genzyme) and Vaccines units is making up for accelerated decline in the diabetes franchise to support the top line.

In fact, at the second quarter conference call, Sanofi raised its previously issued profit outlook backed by a better-than-expected performance in the first half and cost discipline. However, a tough U.S. payer environment hurt sales in theDiabetesunit.

Continued strong performance of the Genzyme unit, especially the multiple sclerosis drugs, Aubagio and Lemtrada, and rare disease drugs like Myozyme/Lumizymeand Fabrazyme is a positive. The Vaccines unit is also expected to perform well. Sales (including emerging markets) rose 14.3% at CER in the Genzyme unit and 24.5% at CER in the Vaccines unit in the first half of 2017.

Meanwhile, Sanofi is quite optimistic about the sales prospects of its newly launched drug Dupixent for treating atopic dermatitis. The drug, which was launched in the United States in March 2017, generated sales of €26 million in the second quarter, backed by strong demand. Management was pleased with the drug’s uptake. We are optimistic on sales prospects of Dupixent, which could prove to be an important growth driver for the company. Other than Dupixent, other new drugs like Kevzara, launched in the U.S. in June 2017,and Soliqua, a once-daily titratable fixed-ratio combination of Lantus and Lyxumia, launched in the United States in January 2017,should also bring in higher sales in the back half of the year.

However, management expects U.S. diabetes franchise sales to decline faster in the second half due to the impact of formulary exclusion at CVS Health Corporation CVS and UnitedHealth Group and difficult comparisons from last year. U.S. diabetes sales declined 19.1% in the first half of 2017.

Sanofi’s Diabetes franchise is under significant pressure with key product, Lantus, facing increasing competitive pressure at the payor level and biosimilar competition in several European markets and Japan.

In the cardiovascular franchise, it also remains to be seen if sales trends of Sanofi’s anti PCSK9 therapy, Praluent improve in the second half. Uptake of PCSK9 inhibitors like Praluent and Amgen, Inc.’s AMGN Repatha have been slower than expected due to significant payer utilization management restrictions in the United States and limited market access in Europe. Praluent’s uptake could remain limited until guidelines supporting broader use of the treatment are issued and phase III cardiovascular outcome study data are out.

Also generic competition will continue to hurt sales of many key drugs in Sanofi’s portfolio including its blockbuster drug, Plavix.

Despite these challenges, we believe that new drug approvals, a solid pipeline and aggressive savings will pave the way for growth at Sanofi.

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http://www.so-l.ru/news/y/2017_09_28_sanofi_rides_on_genzyme_vaccines_unit Thu, 28 Sep 2017 16:23:00 +0300
<![CDATA[Alnylam (ALNY) Stock Down Despite Positive Hemophilia Data]]> Alnylam Pharmaceuticals, Inc. ALNY and Sanofi’s SNY specialty care global business unit, Genzyme, announced encouraging results from the ongoing phase II open-label extension (OLE) study. The evaluation was on fitusiran for the treatment of patients with hemophilia A and B, with or without inhibitors.

Fitusiran is an investigational RNA interference (RNAi) therapeutic being developed for the treatment of hemophilia A and B and rare bleeding disorders (RBD).

In the phase II study, the patients were treated for up to 20 months. In fact, the safety and tolerability profile of fitusiran was maintained in the study. Moreover, the once-monthly subcutaneous (SC) administration of fitusiran led to an 80% lowering of antithrombin (AT) with corresponding increases in thrombin generation. Also, in an exploratory post-hoc analysis of bleeding events, a median annualized bleeding rate (ABR) of one was achieved for all patients compared to zero for the subset of patients with inhibitors.

Notably, the phase II study showed that most of AE were mild/moderate in severity, with most common AE's consisting of transient, mild injection site reactions. However, there was one discontinuation in study due to AE, an asymptomatic alanine aminotransferase elevation in a patient with HCV infection. Meanwhile, shares of the company gained almost 6% on Monday, after the announcement of the data. This could probably be because of the investors; reaction to the one discontinuation in the study.

So far this year, shares of the company have outperformed the Zacks classified Medical - Biomedical and Genetics industry. While, the stock surged 111.6%, the industry registered an addition of 6.6%.

We remind the investors that Alnylam and Sanofi also commenced phase III ATLAS study for fitusiran, last week. Additionally, it mentioned that the initiation of the ATLAS study was based on the positive data from the OLE study.

In fact, another pharmaceutical company, Shire plc SHPG, announced that it has filed an investigational new drug (IND) application with the FDA too. This was done in order to seek approval for its recombinant factor VIII (FVIII) gene therapy candidate, SHP654, to treat patients with Hemophilia A.
Notably, this gene therapy developed by the company treats hemophilia A by selectively targeting the liver.

Moving ahead, the phase III ATLAS study will assess the safety and efficacy of fitusiran in three separate trials, including patients with hemophilia A and B with or without inhibitors and patients receiving prophylactic therapy. Top-line data from the ATLAS trials are expected in mid-to-late 2019.

Alnylam Pharmaceuticals, Inc. Price and Consensus

Zacks Rank & Stocks to Consider

Alnylam currently carries a Zacks Rank #3 (Hold). A better-ranked health care stock in the same space is Enzo Biochem, Inc. ENZ, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Enzo Biochem’s loss per share estimates narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018, over the last 30 days. The company delivered positive earnings surprises in all  the trailing four quarters, with an average beat of 55.83%. The share price of the company has increased 60.1% year to date.

More Stock News: 8 Companies Verge on Apple-Like Run          

Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs. A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>


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Alnylam Pharmaceuticals, Inc. (ALNY): Free Stock Analysis Report
 
Shire PLC (SHPG): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research]]>
http://www.so-l.ru/news/y/2017_07_11_alnylam_alny_stock_down_despite_positi Tue, 11 Jul 2017 23:19:00 +0300
<![CDATA[BioMarin (BMRN) Down 8% Since Earnings Report: Can It Rebound?]]> A month has gone by since the last earnings report for BioMarin Pharmaceutical Inc. BMRN. Shares have lost nearly 8% in that time frame, underperforming the market.

Will the recent negative trend continue leading up to the stock's next earnings release, or is it due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.

BioMarin Posts Earnings in Q1, Sales Rise Y/Y

BioMarin reported earnings of $0.03 per share in the first quarter of 2017 (including stock-based compensation expense), significantly better than the year-ago loss of $0.36 and the Zacks Consensus Estimate of a loss of $0.30 per share. Strong product sales and lower R&D costs pulled up profits in the quarter.

Total revenue came in at $304 million in the quarter, up 28% from the year-ago quarter. The top line was aided by strong net product sales. Revenues also beat the Zacks Consensus Estimate of $292 million by 3.9%. Fx did not have any significant effect in sales in the quarter

Quarterly Details

Vimizim contributed $106 million to total revenue, up 45% year over year and 13% sequentially attributable to the 31% growth in new patients on Vimizim therapy.

The company expects continued growth in 2017 as the franchise continues to benefit from robust underlying patient demand.

Kuvan revenues rose 19% to $92 million, reflecting patient growth in North America and the completion of the transition of the ex-North American territories acquired in 2016. The number of patients on Kuvan therapy in North America increased by 8% in the first quarter.

Naglazyme sales rose 25% year over year to $81 million benefitting from forward purchases from the Middle East markets and booking an order from Brazil in the first quarter of 2017 compared to the absence of the same in the first quarter of 2016. The drug continued to witness steady patient growth with the number of commercial patients increasing 9% in the quarter.

Naglazyme and Vimzim revenues vary on a quarterly basis, primarily due to the timing of central government orders from Latin America.

Though the company booked orders for each of Vimizim and Naglazyme in Q1 from Brazil, it still warned about inconsistent order patterns likely to persist from Brazil in 2017.

BioMarin received Aldurazyme royalties – totaling $19 million (up 19%) – from Sanofi’s Genzyme in the quarter.

Research and development (R&D) expenses declined 8.6% to $127.0 million (excluding stock-based compensation expense) owning to the discontinuance of the Kyndrisa and reveglucosidase alfa programs last year. Selling, general and administrative (SG&A) expenses increased 15.5% to $97.0 million (excluding stock-based compensation expense).

At the end of the first quarter, BioMarin had $1.2 billion in cash, cash equivalents and investments.

2017 Outlook

The company re-affirmed its previously issued 2017 sales and earnings guidance.

BioMarin expects a total revenue in the range of $1.25 −$1.30 billion, representing double-digit revenue growth. The revenue guidance assumes the launch of Brineura in 2017.

Vimizim sales are expected in the range of $400–$430 million while Kuvan sales are projected in the range of $380−$410 million, representing an increase of about 14% over 2016 at the mid-point. Naglazyme sales are projected in the range of $300−$330 million.

R&D expenses are expected within $620–$650 million while SG&A expenses are projected in the range of $520–$550 million.

Due to the ramp up of BMN 270 and vosoritide programs and the Brineura launch and pegvaliase pre-commercialization activities, the company expects R&D and SG&A spending to increase in the later quarters of the year which will result in lower profits. At the call, the company mentioned that it expects to bring a new product candidate into clinical development in 2017.

Adjusted earnings are expected to turn positive. The company expects an adjusted net income of $30 - $70 million in 2017. Meanwhile, management is committed to continued profitability improvements over the longer term.

How Have Estimates Been Moving Since Then?

Analysts were quiet during the last one month period as none of them issued any earnings estimate revisions.

VGM Scores

At this time, BioMarin's stock has a subpar Growth score of 'D' on both growth and the momentum front. Charting a somewhat similar path, the stock was allocated a grade of 'F' on the value side, putting it in the lowest quintile for this investment strategy.

Overall, the stock has an aggregate VGM Score of 'F'. If you aren't focused on one strategy, this score is the one you should be interested in.

Our style scores indicate investors will probably be better served looking elsewhere.

Outlook

The stock has a Zacks Rank #3 (Hold). We are expecting an inline return from the stock in the next few months.


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To read this article on Zacks.com click here.
 
Zacks Investment Research]]>
http://www.so-l.ru/news/y/2017_06_08_biomarin_bmrn_down_8_since_earnings_r Thu, 08 Jun 2017 16:47:00 +0300
<![CDATA[Why Is Alnylam (ALNY) Up 31.2% Since the Last Earnings Report?]]> A month has gone by since the last earnings report for Alnylam Pharmaceuticals, Inc. ALNY. Shares have added about 31.2% in that time frame, outperforming the market.

Will the recent positive trend continue leading up to the stock's next earnings release, or is it due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.

Alnylam Q1 Loss Wider than Expected, Revenues Up year over year

Alnylam reported a loss of $1.25 per share in the first quarter of 2017, wider than the Zacks Consensus Estimate of a loss of $1.22 and the year-ago loss of $1.21.

Quarterly revenues rose 160.3% to $19.0 million. However, revenues missed the Zacks Consensus Estimate of $28.0 million. Revenues in the quarter included $12.3 million earned under the company's collaboration agreement with Sanofi’s subsidiary, Genzyme, as well as $6.4 million from the company’s alliance with The Medicines Company, and $0.3 million from other sources.

Quarter in Detail

Research and development (R&D) expenses fell 9.7% from the year-ago period to $87 million primarily due to lower expenses related to lower stock-based compensation expenses and external services expenses related to pre-clinical activities.

General and administrative (G&A) expenses increased 82.5% to $38.5 million. The increase was primarily due to higher compensation as headcount was increased to support growth. Further, expenses also increased fto prepare for  potential launch of patisiran.

Guidance

Alnylam expects its cash, cash equivalents and marketable securities (including restricted investments) to be greater than $700 million at the end of the year.

Pipeline

Alnylam has been making progress as far as the development of its candidates is concerned. The company reported positive clinical results with fitusiran for haemophilia in Feb 2017. In Mar 2017, the European Medicines Agency (EMA) granted givosiran (ALN-AS1) PRIME Designation for accelerated assessment for the treatment of porphyria based on positive data from a phase I study.

Additionally, the company along with The Medicines Company also reported positive final clinical data from Orion-1 phase II study on inclisiran for hypercholesterolemia. Inclisiran significantly reduced LDL-C and sustained over time. Subsequent to the quarter, in Apr 2017, The Medicines Company announced an agreement with the FDA on plans for phase III study on inclisiran. The primary endpoint will be change in LDL-C from baseline.

The company expects 2017 to be a pivotal year with its first phase III data read out – APOLLO for its late-stage pipeline candidate patisiran by mid-2017 and expects to submit applications for regulatory approvals in the U.S. and Europe at year-end.

How Have Estimates Been Moving Since Then?

Following the release, investors have witnessed an upward trend in fresh estimates. There have been two revisions higher for the current quarter.

Alnylam Pharmaceuticals, Inc. Price and Consensus

 

VGM Scores

At this time, the stock has a poor Growth Score of 'F', however its momentum is doing a lot better with a 'C'. The stock was allocated a grade of 'F' on the value side, putting it in the lowest quintile for this investment strategy.

Overall, the stock has an aggregate VGM Score of 'F'. If you aren't focused on one strategy, this score is the one you should be interested in.

Our style scores indicate that the stock is solely suitable for momentum investors.

Outlook

Estimates have been trending upward for the stock. The magnitude of these revisions also looks promising. Notably, the stock has a Zacks Rank #3 (Hold). We are expecting an inline return from the stock in the next few months.


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To read this article on Zacks.com click here.
 
Zacks Investment Research]]>
http://www.so-l.ru/news/y/2017_06_08_why_is_alnylam_alny_up_31_2_since_the Thu, 08 Jun 2017 10:31:00 +0300
<![CDATA[Sanofi (SNY) Stock Continues to Gain on Key Drug Approvals]]> After declining in 2016, share price of French pharma giant Sanofi SNY has picked up in 2017.

This Zacks Rank #2 (Buy) stock has risen 21.1% this year so far, outperforming the return of the Zacks classified Large-Cap Pharma industry of 8.8%. Let us analyze the reasons for the share price increase

Back-to-Back Product Approvals: Many important pipeline drugs were approved/launched this year, which can boost sales in the next few years. Dupixent (dupilumab) was approved in March this year for the treatment of atopic dermatitis in the U.S. and is now available to adult patients in the U.S. The drug is under review in the EU for the same indication. We are optimistic on sales prospects of Dupixent, which could prove to be an important growth driver for the company. Dupixent is also being evaluated for the treatment of asthma and nasal polyposis in phase III studies and is being positioned by the company as a “pipeline in a product”.

Meanwhile, rheumatoid arthritis (RA) drug Kevzara was also approved in the U.S. in May this year and in Canada in February. Soliqua, a once-daily titratable fixed-ratio combination of Lantus and Lyxumia, was launched in the U.S. in Jan 2017 and is expected to be launched in Europe later this year.

Also, last week, Sanofi announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion, recommending marketing approval to Sanofi’s biosimilar version of Eli Lilly & Company’s LLY Humalog (insulin lispro).

Strong Q1 Results: Sanofi also began the year on a strong note as its first-quarter 2017 sales and profits increased year over year backed by strong Specialty Care (Genzyme) and Vaccines sales. While sales slightly missed estimates, earnings beat the same.

Four of Sanofi’s five key business units recorded growth while headwinds existed in the form of a loss of contribution from the Animal Health segment and a higher tax rate. The company’s multiple sclerosis (MS) franchise is doing well, generating annual sales of €2 billion. Vaccines benefited from strong pediatric combination sales.

Estimates Rise: The strong quarterly results and the back-to-back product approvals led to an uptick in estimates. Sanofi’s earnings estimates for 2017 went up 3.2% while that for 2018 moved up 1.2% in the past seven days. Sanofi’s earnings performance has also been pretty impressive, with the company reporting positive surprises consistently. The average earnings beat over the last four quarters is 5.10%.

Strong Fundamentals: Sanofi possesses a diversified product portfolio. It has a presence in several therapeutic areas including cardiovascular diseases, diabetes, oncology, and central nervous system disorders, among others.

Sanofi has several new products in its portfolio and candidates in its pipeline that can contribute to growth in 2017 and beyond. Products like Aubagio and Lemtrada(multiple sclerosis) have been doing well and the trend is likely to continue.

Meanwhile, Sanofi’s focus on streamlining its business and pursuing business development deals is encouraging. Sanofi has collaboration agreements/partnership deals with companies like Regeneron Pharmaceuticals, Inc. REGN, Alnylam and AstraZeneca plc AZN among others. It also possesses a strong vaccines portfolio, which has been consistently doing well. Promising pipeline candidates include sotagliflozin (SGLT-1 and SGLT-2 inhibitor for diabetes) and is atuximab (multiple myeloma).

Conclusion

Sanofi faces its share of challenges such as generic competition for many drugs including its blockbuster drug, Plavix and slower-than-expected uptake of new products like Praluent. Also, the outlook for its Diabetes franchise is bleak.

However, we believe that new drug approvals, a solid pipeline and aggressive savings will pave the way for growth this year.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

More Stock News: 8 Companies Verge on Apple-Like

Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.

A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
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Astrazeneca PLC (AZN): Free Stock Analysis Report
 
Eli Lilly and Company (LLY): Free Stock Analysis Report
 
Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
 
To read this article on Zacks.com click here.]]>
http://www.so-l.ru/news/y/2017_05_30_sanofi_sny_stock_continues_to_gain_on Tue, 30 May 2017 16:01:00 +0300
<![CDATA[ProQR founder and former Genzyme chief Termeer dies unexpectedly]]> http://www.so-l.ru/news/y/2017_05_15_proqr_founder_and_former_genzyme_chief_t Mon, 15 May 2017 14:48:40 +0300 <![CDATA[Alnylam (ALNY) Q1 Loss Wider than Expected, Revenues Up Y/Y]]> Alnylam Pharmaceuticals, Inc. ALNY reported a loss of $1.25 per share in the first quarter of 2017, wider than the Zacks Consensus Estimate of a loss of $1.22 and the year-ago loss of $1.21.

Quarterly revenues rose 160.3% to $19.0 million. However, revenues missed the Zacks Consensus Estimate of $28.0 million. Revenues in the quarter included $12.3 million earned under the company's collaboration agreement with Sanofi’s SNY subsidiary, Genzyme, as well as $6.4 million from the company’s alliance with The Medicines Company MDCO, and $0.3 million from other sources.

Alnylam’s share price has increased 47% year to date, while the Zacks classified Medical - Biomedical and Genetics industry gained 3.9%.

Quarter in Detail

Research and development (R&D) expenses fell 9.7% from the year-ago period to $87 million primarily due to higher expenses related to lower stock-based compensation expenses and external services expenses related to pre-clinical activities.

Likewise, general and administrative (G&A) expenses increased 82.5% to $38.5 million. The increase was primarily due to higher compensation as headcount was increased to support growth. Further, expenses also increased for the potential launch of patisiran during the quarter.

Guidance

Alnylam expects its cash, cash equivalents and marketable securities (including restricted investments) to be greater than $700 million at the end of the year.

Pipeline

Alnylam has been making progress as far as the development of its candidates is concerned. The company reported positive clinical results with fitusiran for haemophilia in Feb 2017. In Mar 2017, the European Medicines Agency (EMA) granted givosiran (ALN-AS1) PRIME Designation for accelerated assessment for the treatment of porphyria based on positive data from a phase I study.

Additionally, the company along with The Medicines Company also reported positive final clinical data from Orion-1 phase II study on inclisiran for hypercholesterolemia. Inclisiran significantly reduced LDL-C and sustained over time. Subsequent to the quarter, in Apr 2017, The Medicines Company announced an agreement with the FDA on plans for phase III study on inclisiran. The primary endpoint will be change in LDL-C from baseline.

The company expects 2017 to be a pivotal year with its first phase III data read out – APOLLO for its late-stage pipeline candidate patisiran by mid-2017 and expects to submit applications for regulatory approvals in the U.S. and Europe at year-end.

Our Take

Alnylam’s first-quarter results were disappointing with the company reporting a wider-than-expected loss and revenues missing estimates. With several pipeline-related events lined up for the upcoming quarters, we expect investor focus to remain on further updates by the company.

Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise | Alnylam Pharmaceuticals, Inc. Quote

Zacks Rank & Key Picks

Alnylam carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Enzo Biochem, Inc. ENZ, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Enz Biochem’s loss estimates for 2017 narrowed 25% over the past 60 days. The company recorded a positive earnings surprise in the past four quarters, with the average being 39.17%. Its share price is up 27.1% so far this year.

Zacks' 2017 IPO Watch List

Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.

One has driven from 0 to a $68 billion valuation in 8 years. Four others are a little less obvious but already show jaw-dropping growth. Download this IPO Watch List today for free >>


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Alnylam Pharmaceuticals, Inc. (ALNY): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research]]>
http://www.so-l.ru/news/y/2017_05_08_alnylam_alny_q1_loss_wider_than_expect Mon, 08 May 2017 20:59:00 +0300
<![CDATA[Keryx (KERX) Q1 Loss Wider than Expected, Revenues Beat]]> Keryx Biopharmaceuticals Inc. KERX reported first-quarter 2017 loss of 21 cents per share, narrower than the year-ago loss of 39 cents. However, the loss was wider than the Zacks Consensus Estimate of a loss of 18 cents per share.

 

Revenues came in at $11.82 million in the quarter, exceeding the Zacks Consensus Estimate of $10.14 million. Further, revenues improved almost 109% from the prior-year figure of $5.8 million.

Keryx’s share price rose 6.5% following its first-quarter earnings release. In fact, so far this year, the company’s price has increased 5.3%, while the Zacks classified Medical - Biomedical and Genetics industry has witnessed a gain of 4.7% in the same time frame.

Quarter in Details

Net sales of Auryxia in the U.S. were $10.5 million, up 87.5%, following strong prescription growth. A total of 15,800 prescriptions were written in this quarter, up 72% year over year. Also, Auryxia was added to Medicare Part D drug list of two of the largest Medicare Part D insurance providers, which will give the drug unrestricted access to approximately 95% of phosphate binder patients.

Keryx is working on expanding Auryxia's label to include the treatment of iron-deficiency anemia (IDA) in adults with stage III–V NDD CKD. In Mar 2017, the FDA accepted the company’s supplemental New Drug Application (sNDA) for Auryxia for review and gave a Prescription Drug User Fee Act (PDUFA) target action date of Nov 6, 2017.

License revenues came in at $1.3 million, up 8.33% year over year. Keryx earns license revenues from royalties on net sales of Riona (Japan trade name for Auryxia) from its Japanese partners,

Research and development expenses declined 10.5% year over year to $6.8 million, primarily due to a decrease in development work at the company’s contract manufacturers following the approval of a second drug product contract manufacturer. Further, it was affected by a decline in clinical costs following the completion of phase III clinical trial of Auryxia in early 2016.

Selling, general and administrative expenses were $23.1 million, up 11% due to expansion of sales force to support commercialization of Auryxia and costs related to potential launch of Auryxia in IDA.

2017 Outlook

Auryxia sales are expected in the range of $56 to $60 million for the full year. The outlook does not include any sales of Auryxia if it gets approved for the IDA indication

Our Take

Auryxia faces stiff competition in the U.S. from existing players. Apart from over-the-counter drugs like some calcium carbonate and metal-based products including aluminum and magnesium, Sanofi’s SNY specialty medicines arm, Genzyme’s Renagel and Renvela, Shire plc’s SHPG Fosrenol, and Fresenius Medical Care’s FMS PhosLo and Velphoro are already available in the market. Since Auryxia is in early stages of commercialization, the company may face a tough time gaining share.

The company intends to focus on the growth of Auryxia in the U.S. dialysis market. The company’s label expansion efforts on Auryxia in the iron-deficiency anemia (IDA) indication are encouraging, given that the IDA market holds great potential.

Zacks Rank

Keryx currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

More Stock News: 8 Companies Verge on Apple-Like Run

Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.

A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Sanofi (SNY): Free Stock Analysis Report
 
Fresenius Medical Care Corporation (FMS): Free Stock Analysis Report
 
Keryx Biopharmaceuticals, Inc. (KERX): Free Stock Analysis Report
 
Shire PLC (SHPG): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research]]>
http://www.so-l.ru/news/y/2017_05_05_keryx_kerx_q1_loss_wider_than_expected Fri, 05 May 2017 17:37:00 +0300
<![CDATA[BioMarin (BMRN) Posts Earnings in Q1, Sales Top, Stock Up]]> BioMarin Pharmaceutical Inc. BMRN reported earnings of 3 cents per share in the first quarter of 2017 (including stock-based compensation expense), significantly better than the year-ago loss of 36 cents and the Zacks Consensus Estimate of a loss of 30 cents per share. Higher gross margins from net product sales and lower R&D costs pulled up profits in the quarter.

Total revenue came in at $304 million in the quarter, up 28% from the year-ago quarter. The top line was aided by strong net product sales. Revenues also beat the Zacks Consensus Estimate of $292 million by 3.9%

Shares of BioMarin were up more than 2% in after-market hours on Thursday in response to the strong financial results. In fact, so far this year, BioMarin’s shares are up 18.1%, which compares favorably with an increase of 4.7% registered by the Zacks classified Biomed/Genetics industry during this period.

Quarterly Details

Vimizim contributed $106 million to total revenue, up 45% year over year and 13% sequentially attributable to 31% growth in new patients on Vimizim therapy.

The company expects continued growth in 2017 as the franchise continues to benefit from robust underlying patient demand.

Kuvan revenues rose 19% to $92 million, reflecting patient growth in North America and the addition of new patients in the international markets.

Naglazyme sales rose 25% year over year to $81 million. Naglazyme revenues vary on a quarterly basis, primarily due to the timing of central government orders from Latin America. Nevertheless, the drug continued to witness steady patient growth with the number of commercial patients increasing 9% in the quarter.

BioMarin received Aldurazyme royalties – totaling $19 million (up 19%) – from Sanofi’s SNY Genzyme in the quarter.

Research and development (R&D) expenses declined 8.6% to $127.0 million (excluding stock-based compensation expense) owning to the discontinuance of the Kyndrisa and reveglucosidase alfa programs last year. Selling, general and administrative (SG&A) expenses increased 15.5% to $97.0 million (excluding stock-based compensation expense).

Other Updates

Last month, BioMarin announced that it has received approval from the FDA for Brineura for the treatment of children with CLN2 disease, which is a form of Batten disease. With this approval, Brineura is now the first approved treatment for children with CLN2. The company has begun the commercial launch of Brineura in the U.S.

Brineura is also under review in the EU, where a decision should be out by the second quarter of 2017. Last month, BioMarin received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of Brineura in EU.

Last month, BioMarin entered into a settlement agreement with Par Pharmaceutical, subsidiary of Endo International plc ENDP related to a patent infringement lawsuit for Kuvan (tablets and powder). With this agreement, Kuvan should not face generic competition from Par until Oct 1, 2020. The company had earlier entered into a settlement agreement with Dr. Reddy's Laboratories Limited RDY for Kuvan tablets in Sep 2015. The settlement agreement removes an overhang on the shares.

BioMarin has a robust pipeline with several data readouts lined up for the coming quarters. The most important candidate in its pipeline is vosoritide, which is currently in a phase III study for the treatment of children with achondroplasia, the most common form of dwarfism. This will be followed by an open-label extension study with the lower dose (15 µg/kg/day). In addition, BioMarin is planning a separate phase II study to evaluate the effect of vosoritide in infants and toddlers.

The company plans to submit a regulatory application to the FDA for another important pipeline candidate, pegvaliase for the treatment of phenylketonuria in the second quarter of 2017.

2017 Outlook Re-Affirmed

The company re-affirmed its previously issued 2017 sales and earnings guidance.

BioMarin expects total revenue in the range of $1.25 −$1.30 billion, representing double-digit revenue growth. The revenue guidance assumes the launch of Brineura in 2017. Vimizim sales are expected in the range of $400–$430 million while Kuvan sales are projected in the range of $380−$410 million, representing an increase of about 14% over 2016 at the mid-point. Naglazyme sales are projected in the range of $300−$330 million.

R&D expenses are expected within $620–$650 million while SG&A expenses are projected in the range of $520–$550 million.

Adjusted earnings are expected to turn positive. The company expects adjusted net income of $30 - $70 million in 2017. Meanwhile, management committed to continued profitability improvements over the longer term.

BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise

 

BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise | BioMarin Pharmaceutical Inc. Quote

BioMarin sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

More Stock News: 8 Companies Verge on Apple-Like Run

Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007?

Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.

A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>


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http://www.so-l.ru/news/y/2017_05_05_biomarin_bmrn_posts_earnings_in_q1_sa Fri, 05 May 2017 17:30:00 +0300