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BioCentury
Roche’s opportunity
Most analyses of Roche’s offer to buy the rest of
Whether or not Genentech management thinks the initial Genentech Inc. have focused on whether the price is too
offer insulting, they’re big boys and girls and can take it. They low, or Genentech Chairman and CEO Arthur Levinson was know — as does anyone who has done a deal — that the dissed because he wasn’t informed before it was made public, discussion about valuation and the discussion about strategy or whether Roche is taking advantage of the weak dollar, or going forward are not totally codependent.
buying ahead of the upcoming data on Avastin in the Regarding the timing of the offer, yes, the weak dollar may adjuvant colorectal cancer setting, or ahead of the expiration be an incentive to act now. So may the upcoming Avastin of its option on ex-U.S. rights to Genentech products in data, if Roche assumes it will be positive. But both of those 2015. And most have assumed both that the deal is being are tactical considerations for pulling the trigger, not strate- done to gain access to the biotech’s research engine and, somewhat contradictorily, that it will wreck Genentech.
The same can be said for the expiration of the product But our best guess is that these interpretations miss the option, but even more so. In corporate terms, 2015 is an This week’s report on Roche’s proposed Genentech acquisition was reported and written by Editor-in-Chief Karen Bernstein option to ex-U.S. rights to the biotech’s and Senior Writers Aaron Bouchie and p r o d u c t s , a n d i t c o n s o l i d a t e s Stacy Lawrence, with additional reporting Genentech’s U.S. sales on its P&L.
by Senior Editor Peter A. Rittenhouse and offer is an opening bid and it is clear that Staff Writer Stephen Hansen. Data devel- opment was led by Managing Editor Susan Schaeffer, Research Director Walter Yang and Research Manager Kevin Lehnbeuter. make it easier for the two sides to share management was informed of the offer Sunday evening.
novel protein architectures), assets (e.g., chemical libraries), On the pharma’s July 22 earnings call, Chairman Franz intellectual property (e.g., antibody production), unique Humer said the board voted on the plan on Sunday, pre- capabilities (e.g., exploratory development, modeling and sented the plan to the LaRoche family that evening, and simulation) and know-how of the combined research organi- announced it publicly on Monday. According to Humer’s zation will strengthen the Group’s ability to innovate,” letter to Genentech’s three independent directors, this was Roche spokesperson Daniel Piller said via email.
because the pharma “wished to be sure that all Genentech On a conference call, William Burns, CEO of Roche’s and Roche shareholders are fully informed about the pro- pharmaceuticals division, emphasized the importance of the researchers being able to share technologies without getting Whether the ultimate price will match Genentech’s high of $99.66 on Dec. 5, 2005, a year driven by data and sales “You want to move in a more seamless way to be able to for Avastin bevacizumab, is less clear. That is certainly not access technology, make it available to the researchers, what the market is expecting: the stock closed Friday at $96, wherever they are, and allow them to get on with their job,” up $14.18 (17%) on the week. This is the first time the stock he said. “Now you may think it’s a rather soft dimension BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS
Commentary,
What Roche needs
that’s a reality. And therefore, this is not the typical deal that’s designed to big transaction, there are still plenty of ways to muck it up in the execution.
telling, is that Roche’s drugs in the U.S.
quickly put on the P&L. It’s got more to play the traditional big pharma script: years later, the only real value left would year there were more “green lights than even those wouldn’t be getting the care ing products the biotech itself partnered, Genentech’s products; the overall phar- Roche’s play on Genentech in the 1990s, financial engineering in addition to gain- for only CHF3.9 billion ($3.3 billion). you’ve got to address that issue,” Humer selling off bits of the biotech as it did in hind which is the very clever strategy of combining Genentech and Roche’s U.S.
Be that as it may, the state of Basel’s the pharma’s reliance on the biotech’s Make a splash
CHF17.9 billion ($15 billion), or 58%.
T h e t o p t h r e e s e l l e r s c a m e f r o m Genentech, as did five of the top 10.
DAVID FLORES
KAREN BERNSTEIN, Ph.D.
BioCentury®
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BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS
Commentary,
Co. Ltd. is contributing three NMEs in Phase III develop-
At the same time, the numbers illustrate how much more Only three of the top 10 were Roche drugs. aggressive Genentech has been on market development than Last week, Burns told the conference call that the issue of has Roche: Genentech drugs with line extensions account for a more challenging U.S. environment for pharmaceutical 10% of Roche’s pipeline, while Roche’s account for 6%, not sales in general is “peripheral to the main event,” which is to counting another 6% of products that the pharma has not enhance R&D. But the numbers argue that building strategic access to the U.S. market by acquisition, rather than retool- Indeed, in the past 10 years alone, Genentech has ob- ing, retraining or refurbishing the company’s Nutley opera- tained FDA approvals for at least seven label expansions. By contrast, of the 12 products Roche has launched in the Along the way, Roche also would continue to get U.S. since 1995, only three have been major successes, and Genentech’s research engine. The obvious question is how none is selling over $1 billion in the U.S.: CellCept much innovation this will inject into the pharma’s future, mycophenolate for transplant rejection, which was approved although the biotech arguably looks more efficient in bring- in 1995; Xeloda capecitabine for breast, colorectal and ing its own research and in-licensed projects to market than gastric cancers, which was approved in 2001; and Boniva ibandronate for osteoporosis, which was approved in 2005.
Roche’s pharmaceuticals division spent CHF7.6 billion Meanwhile, several drugs have proven to be disappoint- ($6.4 billion) on R&D in 2007 and has at least 33 in-house compounds in the clinic, of which 23 are disclosed to be The first was Posicor mibefradil, a T channel calcium novel. Genentech spent $2.3 billion on R&D last year and has channel antagonist for hypertension and angina. Approved about 29 compounds in the clinic, of which 21 are novel. in June 1997, it was pulled from the market a year later. A In terms of Roche’s late-stage pipeline, neither side is Phase IV trial failed to show a mortality benefit in congestive contributing much at the moment. Genentech has only two heart failure, and it was clear that it had lots of drug-drug novel compounds in Phase III, while Roche Pharma has none.
interactions — more than 25 — including with nitrates and Indeed, Roche’s 59.9% owned Chugai Pharmaceutical
Roche’s top 20
Drugs either discovered or derived from partnerships with Genentech (NYSE:DNA) accounted for nine of Roche’s top 20 drugs in 2007. Global sales
of these drugs represented 58% of the total 2007 sales of the top 20. Moreover, of the 18 drugs in the top 20 with U.S. sales, Genentech’s products accounted
for 73% of the total sales in the group. (A) Since OSI (NASDAQ:OSIP) initially did the Tarceva deal with both Genentech and Roche (SWX:ROG), U.S.
sales of the drug were allocated to Genentech and the rest of world sales went to Roche in calculating the percentage of global sales tied to each company;
Green = Genentech drug or drug from Genentech deal; Blue = Roche drug or drug from Roche deal
Product [ranked by global sales]
Global sales
Product [ranked by U.S. sales]
U.S. sales
CHF30.7B ($25.8B)
CHF14.2B ($11.9B)
BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS
Commentary,
“thus significantly enhancing its ability to leverage international clinical trials A l s o d i s a p p o i n t i n g w a s T a s m a r tolcapone for Parkinson’s disease (PD), to California from Nutley,” he noted.
does this better than Nutley. If not, then Genentech’s “remuneration culture,” in- marketed by Valeant Pharmaceuti-
cals International.
lipase inhibitor that was approved in1999 to treat obesity, was supposed to Roche sales breakdown
be a blockbuster. But it wasn’t user-friendly: its main side effects are gas- As a unit of Roche (SWX:ROG), sales from Genentech (NYSE:DNA) accounted for 28% of the big
pharma’s total drug sales in 1H08, compared to 17% looking back 5 years to 2003. The biotech’s sales accounted for 71% of Roche’s total drug sales in North America in 1H08.
now also sold in a low dose over-the-
c o u n t e r f o r m u l a t i o n b y G l a x o -
On a product basis, drugs from Genentech accounted for nearly two-thirds of global sales of the SmithKline plc. Worldwide sales in
top 20 drugs listed by Roche in 1H08, compared to 33% in 2003. (A) U.S. sales of Tarceva allocated to Genentech and the rest of world sales went to Roche, as OSI (NASDAQ:OSIP) initially did the
3UHVFULSWLRQ VDOHV E\ XQLW
strated its ability to build markets in itsfranchise areas through aggressive post- take of Activase tPA proved slow,Genentech ran the 41,021-patient GUSTO study to show it was better atreducing mortality in heart attack pa- “That’s good clinical marketing,” said an ex-Roche manager who did not wantto be identified. “That’s what Genentech 1RUWK $PHULFDQ VDOHV
has done well — a strategy to fullysupport their molecules and really de- velop the market. And that’s what Roche has never done — get the data to sup-port the brands.” Genentech has done with Avastin.
clinicaltrials.gov lists 459 trials of Avastin(many of which aren’t being run by the company), but Genentech says it’s test- Sales RIW
drugs  (A)
indications; clinicaltrials.gov shows 254 commercial center of gravity to SouthSan Francisco will provide a sort of shock therapy to Roche’s internationalproduct development teams (IPDs).
BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS
Commentary,
happy dining; if a Genentecher is in charge, Schwan’s first big move as CEO may be the best one he ever makes.
Genentech management and puts an outsider in charge. In that event, Roche could be left in two years with the worst Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan
of all possible worlds, having killed both Nutley and South Genentech Inc. (NYSE:DNA), South San Francisco, Calif.
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K.
Assuming the deal goes through, the world will know Roche (SWX:ROG), Basel, Switzerland
fairly quickly just how smart Basel is: if a Roche person is in Valeant Pharmaceuticals International (NYSE:VRX), Aliso Viejo,
charge, Schwan will be killing the goose, and we wish him Genentech pipeline
More than half of Genentech’s clinical pipeline of NMEs comes from external sources, including licensing deals as well as its Tanox acquisition. Onlya few NMEs are in Phase III, while the company has a significant number of line extensions filling the late-stage portfolio. (A) Discovered by Genen-tech under a 2003 collaboration with Curis; (B) Compound linking Genentech’s Herceptin trastuzumab with ImmunoGen’s DM1 toxin In-house - NMEs
Product [partner]
Status [indication]
Ph III [1st-line HER2-pos metastatic breast cancer]; Ph II Ph II [non-Hodgkin’s lymphoma (NHL), non-small cell lung cancer (NSCLC)]; Ph Ib [colorectal cancer] Ph II [colorectal cancer, basal cell carcinoma (BCC), Ph II [HER2-pos metastatic breast cancer] In-licensed - NMEs
Product [partner]
Status [indication]
Ph III [rheumatoid arthritis (RA), lupus]; Ph II [relapsing- Ph II [hepatocellular carcinoma (HCC), renal cell carci- noma (RCC), NSCLC, breast cancer and colorectal cancer] Ph II [NHL, NSCLC]; Ph Ib [colorectal cancer] Ph II [B cell lymphoma]; Ph I [B cell lymphoma, multiplemyeloma (MM), follicular NHL] Ph I/II [chronic lymphocytic leukemia (CLL), small celllung cancer, lymphoid malignancies] 3rd-generation anti-CD20 mAb [Biogen Idec] Anti-IL13 (TNX-650) [from Tanox acquisition] BioCentury makes people think
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BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS
Genentech Pipeline,
from previous page
In-licensed - NMEs (continued)
Product [partner]
Status [indication]
Ph I [secondary prevention of cardiovascular events] In-house - line extensions
Product [partner]
Status [indication]
Ph III [1st-line metastatic RCC, relapsed glioblastomamultiforme (GBM), adjuvant colon cancer, adjuvant HER2-neg breast cancer, adjuvant HER2-pos breast cancer,adjuvant NSCLC, diffuse large B cell lymphoma, 1st-lineadvanced gastric cancer, 1st-line HER2-neg metastaticbreast cancer,1st-line HER2-pos metastatic breast cancer,1st-line metastatic ovarian cancer, gastrointestinal stromaltumors (GIST), high risk carcinoid, hormone refractoryprostate cancer, newly diagnosed GBM, metastatic headand neck cancer, relapsed platinum-sensitive ovariancancer, 2nd-line metastatic breast cancer]; Ph III [plusTarceva for 1st-line metastatic non-squamous NSCLC]; PhII [extensive SCLC, non-squamous NSCLC w/previouslytreated CNS metastases, relapsed MM] Ph III [diabetic macular edema, retinal vein occlusion] TNKase tenecteplase [Boehringer Ingelheim] Ph III [central venous access device occlusion, catheterclearance] In-licensed - line extensions
Product [partner]
Status [indication]
CD20Ph III [RA DMARD-inadequate responders, active RA, ANCA-associated vasculitis, lupus, CLL, follicular NHL] Ph III [adjuvant NSCLC, 1st-line metastatic NSCLC]; Ph III[plus Avastin for 2nd-line metastatic NSCLC]

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