The Biotech Corner: Valeant Pharmaceuticals Intl Inc (VRX), Regeneron Pharmaceuticals Inc (REGN), and Mylan NV (MYL)

The biotech world is buzzing after a criminal charge-laden press release has circled the name of Valeant Pharmaceuticals Intl Inc (NYSE:VRX), Regeneron Pharmaceuticals Inc (NASDAQ:REGN) prepares to continue its clinical Phase 3 trial following a second interim analysis, while Mylan NV (NASDAQ:MYL) released its earnings report last week.

Analysts from Canaccord and BTIG are sidelined in their perspectives on VRX and REGN, yet when it comes to MYL, a top Wall Street analyst at Mizuho maintains a bullish perspective, albeit with a price target cut. Let’s delve deeper:

Valeant Does Not Have a Yellow Brick Road Ahead

Yesterday, November 17th, the U.S. Department of Justice issued a press release detailing criminal charges filed against former Valeant executive Gary Tanner as well as against former CEO of Philidor Rx Services Andrew Davenport.

The DOJ alleges that Tanner improperly utilized his role in power as an executive at the troubled biotech giant to collude with Davenport in helping negotiate VRX’s purchase option of Philidor, which led to $40 million to find its way back to Davenport and $10 million paid in kickbacks to Tanner.

Additionally, the suit claims Tanner further manipulated his power at the firm to increase the total of products sold through Philidor, thereby amplifying VRX’s need to rely on the specialty pharmacy. Furthermore, it is alleged Tanner defied endeavors to have receivables collected.

In reaction to yet another negative press release in a line of criminal charges that have plagued the giant, Canaccord analyst Neil Maruoka reiterates a Hold rating on shares of VRX with a $17 price target, which represents just under a 5% downside from current levels.

Ultimately, “In our view, this news should not have any major impact on Valeant and we note that these charges do not relate to financial statement fraud, or with the company intentionally inflating revenues (as many speculated in the past when the Philidor story first broke). Further, in its statement, the DoJ made no mention of former CEO Michael Pearson, or former CFO Howard Schiller; however, the FBI indicated that the investigation is still ongoing. We believe this type of negative headline risk is just one of a number of potential issues to keep a close eye on in the near-term,” Maruoka contends.

Moving forward, Valeant is left confronting many challenges ahead, as it recently has indicated “several disappointing operational updates,” from persisting pricing pressure, a declining year-over-year unit volume growth in its dermatology segment, an FDA Warning Letter arising from the agency’s inspection of VRX’s manufacturing facility in Rochester, NY, and a delay of three-months for the PDUFA date for pipeline psoriasis drug brodalumab.

As usual, we recommend taking analyst notes with a grain of salt. According to TipRanks, Neil Maruoka is ranked #4,140 out of 4,229 analysts. Maruoka has a 12% success rate and faces a loss of 43.5% in his annual returns. When suggesting VRX, Maruoka loses 38.9% in average profits on the stock.

TipRanks analytics exhibit VRX as a Hold. Out of 12 analysts polled by TipRanks, 2 are bullish on Valeant stock, 8 remain sidelined, and 2 are bearish on the stock. With a return potential of 30%, the stock’s consensus target price stands at $23.45.screen-shot-11-18-16-at-05-25-pm

Regeneron Investors Likely to Remain Tentative and Under Watch by the Street

Yesterday morning, Regeneron and Sanofi announced that their collaborative Phase 3 ODYSSEY OUTCOMES study will continue to follow a pre-specified interim analysis of the data.

This comes as a bit of a surprise to BTIG analyst Dane Leone who on the heels of the announcement reiterates a Neutral rating on REGN without listing a price target.

Leone notes, “We were not expecting an early stop to the trial, but in tandem with limited differentiation of cardiovascular events within the Repatha trial, investors may remain cautious regarding the potential for success. Differentiation of cardiovascular outcomes remains a key potential driver for adoption of PCSK9 therapy relative to high dose statins, and will continue to be watched closely by the Street.”

However, “The interim analysis most likely did not achieve overwhelming efficacy, but the determination of study continuation does not necessarily imply that CV events within the Praluent arm are not statistically lower than the control,” Leone believes.

Additionally, Amgen has achieved a primary outcome for Repatha, designed to help lower LDL (low-density lipoprotein) cholesterol, the kind that puts your heart most at risk, indicating a positive trend in reducing major cardiovascular events.

The analyst maintains sales projections for Praluent, approved as an injection treatment to lower cholesterol, and believes the market is split 50/50 between Praluent and Repatha, with Praluent’s revenue anticipated to reach $1.3 billion by the year 2020. From Leone’s perspective, these drugs are “generally undifferentiated.”

“If the OUTOMES trial data does hit statistical significance upon completion, 2020 sales could ramp faster along the adoption curve, making our current estimates for 2020 seem a bit conservative,” Leone concludes.

According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, five-star analyst Dane Leone is ranked #107 out of 4,229 analysts. Leone has a 74% success rate and gains 12.5% in his yearly returns. When recommending REGN, Leone earns 0.0% in average profits on the stock.

TipRanks analytics demonstrate REGN as a Hold. Based on 15 analysts polled in the last 3 months, 4 rate a Buy on REGN, 10 maintain a Hold, while 1 issues a Sell. The 12-month price target stands at $458.69, marking a nearly 14% upside from where the stock is currently trading.screen-shot-11-18-16-at-05-27-pm

Mylan Still in a Solid Position Despite Earnings Season Challenges

Mizuho top analyst Irina Rivkind Koffler notes that “generic stocks have struggled through the earnings season.” But where does Mylan fare in the midst of the uphill climb? From Koffler’s perspective, “we continue to view MYL as one of the best positioned” despite shares that “weakened after a 3Q:16 miss and muted outlook for 2017-2018” and reiterates a Buy on MYL while trimming the price target from $49 to $47, which represents just under a 28% increase from where the stock is currently trading. The slight pull-back on price target stems from the firm’s dip in revenue growth projections. However, Koffler points to a partial offset from better operating margins.

The firm’s management team anticipates a growth into the “low teens” from its bottom line from 2017 through 2018, with the analyst adding, “but not it’s top line,” coupled with reliance on additional “tuck-in” deals to reach an EPS target of $6.00. The Street projects over 15% in top line growth for 2017, and Koffler believes management may have expectations for the firm to reach the top of its guidance range of $11.5 billion for 2016. Moreover, management expressed intentions to look into a substantial restructuring program to help bolster further operating expense “efficiencies.”

Koffler explains, “We still think Mylan is better positioned than its peers, with several 2017 catalysts and a 1Q:17 Investor Day that could provide momentum.”

Though the $331 million that came from Meda, the firm’s Swedish cash-and-stock purchase underperformed the analyst’s expectations, she notes that nonetheless, “Mylan’s U.S. generics business did not deteriorate to the same degree as some of its competitors.”

Additionally, the analyst has cut EpiPen estimates after management “backed away” from its sales projection of $1.1 billion on back of inventory destocking and generic launch, now modeling $827 million in 2016 sales and a  forecast of $822 million in 2017.

Overall, “We still believe that Mylan will be able to capture a significant portion of the market with its generic and also to expand overall market growth. Mgmt indicated it plans to continue investing in access and awareness,” Koffler surmises.

According to TipRanks, top five-star analyst Irina Rivkind Koffler has achieved a high ranking of #63 out of 4,229 analysts. Koffler upholds a 51% success rate and garners 17.8% in her annual returns. When rating MYL, Koffler yields 3.6% in average profits on the stock.

TipRanks analytics indicate MYL as a Buy. Out of 14 analysts polled by TipRanks, 10 are bullish on Mylan stock and 4 remain sidelined. With a return potential of nearly 45%, the stock’s consensus target price stands at $53.42. screen-shot-11-18-16-at-06-12-pm

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