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.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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