Saturday, October 27, 2012

Vertex To Release Q3 2012 Hep C Revenue Data Monday

FINAL UPDATE | 11.01.12:

Vertex reports that (as I predicted) 75 percent of all new Hep C current-gen patients — some $254 million worth in Q3 2012, alone — are receiveing Incivek, over Victrelis (New Merck/legacy Schering-Plough). However, it seems many of the less severely afflicted Hep C positive patients are waiting — deferring any treatment — for the arrival of the all-oral next-gen Hep C “cures” now in Phase II/III clinical trials.

UPDATED: Call now moved to November 1, 2012, due to Sandy.

Next up, on Thursday Monday evening, Vertex Pharmaceuticals reports its third quarter revenue from telaprevir, branded as Incivek. I expect at least a 75-25 advantage in market share, for Vertex, over the rival Merck (actually, legacy Schering-Plough) drug, boceprevir.

But we shall see. You may tune in here:
. . . .As a result of the effects of Hurricane Sandy and the related closure of the financial markets, Vertex Pharmaceuticals Incorporated today announced that it has rescheduled its third quarter 2012 earnings press release and conference call, which were originally scheduled for today, Monday, October 29. Vertex will now announce its third quarter 2012 financial results on Thursday, November 1, 2012 after the financial markets close. The company will host a conference call at 5:00 p.m. EDT on Thursday. . . .

. . .Oct 29, 2012 | 5:00 PM ET
Vertex Pharmaceuticals Incorporated Third Quarter 2012 Financial Results Conference Call.  . . .
We will report on it, then. As ever, be careful out there.

Friday, October 26, 2012

Merck Q3: $0.95 Non-GAAP EPS; 5% Sales Down-Bubble From Currencies

All in all, a pretty solid quarter from the No. 2 publicly-traded pharma company in the world -- given that this is the first quarter in which Singulair® began falling off the patent cliff.

Although scarcely material, it is interesting that Victrelis® (boceprevir) -- the legacy Schering-Plough Hep C drug -- recorded just under $150 million in sales for Q3 2012. That reflects a pretty strong launch year, but the more important comparison will be against Vertex's Q3 results, for Incivek® (telaprevir) -- generally regarded as the more-efficacious of the two presently available major next-gen Hep C regimens. I still expect that split to be above 75-25, in favor of Vertex.

Again, hats off to Whitehouse Station -- this is very nice performance, in a turbulent transition over the patent cliff for several of Merck's long-standing, and largest franchises. One other important year-end metric will be revealed when we learn how much currency hedge loss the company has recorded for the year, in January 2013. The alternative metric will be the simple year over year sales decrease driven by the relatively strong US dollar in inernational markets.

Even so, Merck is naturally hedged to a fair extent, by holding manufacturing and research and distribution assets in local markets -- thus enjoying a counter-effect to the otherwise straight decline in USD exchanges, as these assets in local currency increase in value roughly an equal proportion. From the SEC Form 8-K, filed this morning:
“. . . .Our strong global sales this quarter offset the impact of the SINGULAIR patent expiry in the U.S.,” said Kenneth C. Frazier, chairman and chief executive officer of Merck.  “We will continue to drive value for our customers and shareholders through Merck’s four-part strategy of executing on our core business, expanding geographically in high-growth markets, extending our complementary businesses and excelling at managing our costs while investing for growth.  With our robust pipeline, we remain on target to submit multiple new products for marketing approval between now and the end of 2013, including suvorexant for insomnia, odanacatib for osteoporosis and TREDAPTIVE for multiple lipid parameters. . . .
In any event, do stay tuned for year end 2012 results now -- come late January 2013.

Friday, October 19, 2012

Merck Signs Supreme Court Brief: For Inclusion And Diversity

Bloomberg Business Week is reporting this morning that Merck signed the amici brief filed by Chicago's Jenner & Block, in the pending Supreme Court review of whether gender-, color-and background conscious admission, hiring and promotion policies are still constitutionally-permissible, thus:

. . . .Some of the biggest corporations in America say that having a diverse payroll helps boost sales, and they want the Supreme Court to keep that in mind as it considers this term’s affirmative-action case. The justices heard oral arguments on Oct. 10 that addressed whether the University of Texas may favor racial minorities in admissions. Aetna (AET), Dow Chemical (DOW), General Electric (GE), Halliburton (HAL), Merck (MRK), Microsoft (MSFT), Northrop Grumman (NOC), Procter & Gamble (PG), Wal-Mart Stores (WMT), Xerox (XRX), and 47 other companies filed a friend-of-the-court brief arguing that the case has bottom-line business implications as well. . . .
Merck says having people of South Asian and Arab descent on the payroll has helped drive sales. The company had anticipated that Muslim women would be hesitant to use its Gardasil, a vaccine that protects against the virus that causes cervical cancer. So, Merck told the court in the brief, it “sought the assistance of its Muslim employees in obtaining halal certification”—the Islamic equivalent of the kosher stamp of approval—for the vaccine. “Having a diverse workforce helped us get this product to market faster and ensure that it would be well-received by customers around the world,” says Bruce Kuhlik, Merck’s executive vice president and general counsel. . . .

I could write volumes here, on the value of inclusion and diversity in the emerging multinational workforce, but I'll refrain. I'll just say "Kudos here go to CEO/Chair Ken Frazier, and the Merck HR team!"

Monday, October 15, 2012

Oral HCMV Candidate In-Licensed From Europe's AiCuris

The market for an effective cytomegalovirus vaccine would appear to be very substantial -- as human organ transplantation rates grow substantially, world-wide (in the developed world, at least). It's a nice bet for MSD Corporate Development and MRL to make. For its part, AiCuris has a strong and growing reputation here (it is a 2006 spinoff from the EU's Bayer conglomerate). Do read the full presser here -- but a snippet:
. . . .Merck. . . and AiCuris today announced that they have entered into an exclusive worldwide licensing agreement for AiCuris' novel portfolio of investigational medicines targeting Human Cytomegalovirus (HCMV), including letermovir (AIC246), an oral, late-stage antiviral candidate being investigated for the treatment and prevention of HCMV infection in transplant recipients. . . .
Merck will gain worldwide rights to develop and commercialize candidates in AiCuris' HCMV portfolio. AiCuris will receive a €110 million upfront payment and is eligible for milestone payments of up to €332.5 million based on successful achievement of development, regulatory and commercialization goals for HCMV candidates, including letermovir, an additional back-up candidate as well as other Phase I candidates designed to act via an alternate mechanism. In addition, AiCuris will be entitled to receive royalty payments reflecting the advanced stage of the clinical program on any potential products that result from the agreement. Merck will be responsible for all development activities and costs. . . .

We will keep you posted.

Sunday, October 14, 2012

Been Off The Grid Far Too Much Lately. . . .

And so (again), I am woefully late in pointing out, as my commenters so helpfully have, before me -- that Merck is going to move HQ back to the former Animal Health old Kenilworth site of legacy Schering-Plough -- though Kenilworth was still for sale as late as year-end 2011.

Here is the best piece on it -- naturally, from Ed, at -- do go read it all.

From my commenters, much more, then too:

. . . .Condor. . . here's a follow up to Anon #1's post that is quite curious. Somerset County shouldn't care all that much about Merck's move since it sits smack between the Whitehouse/Readington and Summit locations. One would think this was the best place to be for the move. . . .

We will keep you updated -- and try to get around here to tidy the place up a little more often. I've been off on some wonderful real world adventures, of late.

Tuesday, October 9, 2012

Merck To Fund Vaxxas: "Nanopatch" Vaccine Delivery Technology

Using a skin patch as a needle-free vaccine delivery system has great potential -- in the developed world, certainly (less so outside of it). This is certainly a smart match -- Merck's highly-esteemed vaccine-making prowess -- with what may well be the next wave in delivery: "nanospears" coated with the vaccine, on an adhesive skin patch. Slap it on, and go.

No pain, and a greatly reduced risk -- to all health care workers -- from needle sticks and the potential for biohazards more than occasionally transferred thereby.

In addition, Vaxxas this morning named its first CEO -- David Hoey, an alum of another Healthcare Ventures investment called Pathogenetix. Healthcare Ventures is an investor in Vaxxas.

From the presser on MarketWire, then:
. . . .The collaboration will evaluate Vaxxas' proprietary NanopatchTM platform that induces robust immune system activation by targeting vaccine to the abundant immunological cells immediately below the surface of the skin. In addition, Vaxxas has granted Merck an exclusive license for the Nanopatch platform for commercial production of an undisclosed vaccine candidate.

Under the agreement, Merck will pay an upfront fee and will provide funding to Vaxxas to conduct research evaluating the potential of using Vaxxas' Nanopatch platform for a Merck vaccine candidate. Vaxxas will be eligible to receive additional payments associated with Merck exercising its option to the Nanopatch platform for the development and commercialization of vaccine candidates for up to two additional fields. Vaxxas will also be eligible to receive payments upon achievement of development milestones and regulatory approvals by any Merck vaccine candidate that uses the Nanopatch platform as well as royalties on sales of such Merck vaccine products. . . .

This will be one to watch. So we will.

Friday, October 5, 2012

Merck's MSD Ireland To Cut 90 More Jobs At Legacy Schering-Plough Cork Facility

This comes on the heels of a 160 person reduciton at the legacy Schering-Plough Cork facilities, in September of 2010. Do go watch it all at RTE

. . . .Over the next six months, 90 voluntary redundancies will be sought from 455 staff. The company employs a total of 2,300 people in Carlow, Dublin, Tipperary, Wicklow and Cork. The job cuts follow a decision by the company to reduce production levels of the Hepatitis C drug Interferon. MSD site manager Matt Corcoran said that "reducing the workforce is necessary and sadly unavoidable for the site to stay competitive". . . .
Here's to hoistin' one -- for my cousins -- stay strong! It will get better. And already a tech company -- Hittite Microwave -- has announced 30 new jobs, in Cork this afternoon, local time. Sure, and begorrah.

Former Schering-Plough CEO "Fast Fred" Hassan To Chair Avon Board

More later -- but Ms. Jung is stepping away. The only quibble I have with the coverage of it thus far is the occasional reference to Mr. Hassan as a "turnaround specialist." He is not. He is a bust-up and sell-off specialist. He is as much a turnaround specialist as Mr. Romney is a living wage jobs creator. He just isn't.

In any event, here is a link to a story in the WSJ which cites a company presser touting his turnaround experience.

Tuesday, October 2, 2012

Merck Follows Four Other Majors -- In Striking Ion Channel Deal With Ablynx

This specific ion channel deal with Merck & Co. could be (with milestone related optional payments) worth up to about $580 million -- or 448 million euros to Ablynx. Merck now joins a crowded field betting on this particular iteration of nanobody tech, as a vehicle for for future drug delivery approaches. Even the oft-confused European Merck (called Serono) has a prior deal with Ablynx. Here's a bit; do go read it all

. . . .The Ghent-based biotechnology company, which listed on Euronext Brussels in November 2007, said that upon signing of the agreement it would receive a 6.5 million euro initial payment and a 2 million euro fee for research funding. Merck, known as MSD outside the United States and Canada, will gain exclusive rights to nanobodies directed towards a voltage-gated ion channel with the option to develop a nanobody to a second target. . . .
Whether this approach fails or flies, Whitehouse Station cannot afford to be on the sidelines here -- with all the other major players placing bets at this Roulette Wheel. We will keep you posted.