Puma in­vestors fret, as Ner­l­ynx Q1 sales fall un­com­fort­ably short of Wall Street es­ti­mates

“We are not pleased with our first-quar­ter Ner­l­ynx rev­enues,” Puma Biotech­nol­o­gy chief Alan Auer­bach said in a post-earn­ings con­fer­ence call on Thurs­day, cit­ing a spate of dis­con­cert­ing fac­tors, in­clud­ing pa­tient dis­con­tin­u­a­tions. In­vestors con­curred with his as­sess­ment, as the stock $PBYI cratered. The dis­dain con­tin­ued ear­ly Fri­day, as shares fell near­ly 37% to $18.96 be­fore the bell.

Alan Auer­bach

The drug, which was in-li­censed by Puma from Pfiz­er $PFE, was ap­proved by the FDA in Ju­ly 2017, to pre­vent breast can­cer re­lapse, fol­low­ing ther­a­py in pa­tients with HER2-pos­i­tive can­cer. The treat­ment is known to have a poor tol­er­a­bil­i­ty pro­file, pre­dom­i­nant­ly re­lat­ing to di­ar­rhea. The Los An­ge­les-based com­pa­ny post­ed Q1 Ner­l­ynx sales of $45.6 mil­lion — a 25% de­cline quar­ter-over-quar­ter — and well be­low Street con­sen­sus ex­pec­ta­tions of about $67 mil­lion.

“The dis­con­tin­u­a­tions oc­cur more fre­quent­ly in the first month. While most physi­cians pre­scribe an an­ti-di­ar­rheal med­ica­tion with Ner­l­ynx, our re­search shows that some pa­tients may not fill the an­ti-di­ar­rheal pre­scrip­tion. There were al­so some physi­cians not pre­scrib­ing any an­ti-di­ar­rheal pro­phy­lax­is med­ica­tions at all, which we be­lieve was due to the lack of aware­ness of the da­ta from our con­trol tri­al us­ing pro­phy­lac­tic an­ti-di­ar­rheal drugs,” Puma CCO Steven Lo said on the call.

Steven Lo

Oth­er rea­sons for the sales miss were at­trib­uted to: pa­tient dis­con­tin­u­a­tions ow­ing to the pro­gres­sion of the dis­ease, or loss of in­sur­ance; an ab­nor­mal­ly high va­can­cy rate in the sales force, with 18 of 80 sales ter­ri­to­ries en­dur­ing turnover dur­ing the quar­ter; and pa­tients com­plet­ing one year of treat­ment on Ner­l­ynx as in­di­cat­ed on the la­bel.

“The neg­a­tive im­pact from treat­ment dis­con­tin­u­a­tions di­rect­ly re­lat­ed to Ner­l­ynx’s chal­leng­ing tol­er­a­bil­i­ty pro­file, which has seem­ing­ly had a re­laps­ing/re­mit­ting im­pact on quar­ter­ly com­mer­cial re­sults, was ex­plic­it­ly de­scribed as worse than ex­pect­ed – in­creas­ing­ly se­quen­tial­ly…Def­i­nite­ly more dis­con­cert­ing, how­ev­er, was the rev­e­la­tion that at cer­tain pe­ri­ods dur­ing the quar­ter, the com­pa­ny’s “high­er than av­er­age va­can­cy rate in (their) sales force” with 18 of 80, or 22% of sales ter­ri­to­ries ‘not hav­ing a sales rep at some point in the quar­ter.’ While seats have ap­par­ent­ly been most­ly re-filled…this sce­nario rais­es con­cerns re­gard­ing the sus­tain­abil­i­ty of the ap­par­ent re­bound seen in April (2Q to date). How­ev­er, the sub­dued tone with which com­men­tary was de­liv­ered, makes it chal­leng­ing to muster con­fi­dence that com­mer­cial dy­nam­ics can achieve even low­ered full-year 2019 Ner­l­ynx sales guid­ance,” Cowen an­a­lysts wrote in a note.

SVB Leerink an­a­lysts low­ered their 2019 US rev­enue es­ti­mates to $221 mil­lion from $265 mil­lion and tem­pered their peak US sales ex­pec­ta­tions to about $369 mil­lion from $400 mil­lion.

Af­ter suc­cess­ful­ly lob­by­ing Eu­ro­pean reg­u­la­tors to have a change of heart and ap­prove Ner­l­ynx last year, Puma palmed off the treat­ment to Pierre Fab­re — its sixth mar­ket­ing part­ner —with the Unit­ed States and Japan as the on­ly re­main­ing un­en­cum­bered ma­jor mar­kets.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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