Squeezed for cash

We have reached the edge of the great pharmaceutical patent cliff — those years when a large number of blockbuster drugs lose patent protection and are open to generic competition. Right on schedule, the major bio/pharma companies are making the big strategic and financial moves that the industry has been expecting: big mergers, massive staff reductions (especially in sales and marketing), and an intensified focus on inlicensing and acquisition of promising drug candidates from smaller companies.

Jim Miller

As well as preparing for the looming loss of blockbuster products, companies have also had to contend with the implications of the global financial crisis. The near meltdown of the financial system has heightened the respect for risk and created the sense that you can never have too much cash. Cash flow has not been a problem for Big Pharma for decades and there has been ready access to capital markets: five of the biggest bio/pharma companies have raised more than $80 billion (€54 billion) this year to fund acquisitions and other corporate activities, according to PharmSource. Even so, pharma companies are focusing on cash flow management as never before and working capital (cash used to finance current assets such as inventory and accounts receivable) has been a principal target in these efforts. This is having a major negative impact on CMOs.

Targeting inventories

The big concern for CMOs is the focus on inventory levels. Major companies are trying to turn their inventories more quickly, i.e., reduce the amount of inventory they carry relative to sales volume. Back when good cash management wasn't such a big concern, major companies would carry inventory equivalent to as much as 6-months' of product sales. Things have improved somewhat since then, but many companies still carry more than 4months' worth of sales in inventories, despite working all year to reduce that. Consumer products powerhouse Procter and Gamble, by contrast, only carries 2-months' worth of inventory in its warehouses.

There was a time when companies could unload inventories by selling products at a significant discount to drug wholesalers such as Cardinal Health and AmerisourceBergen. After some companies ran into legal troubles for this practice, however, many switched to paying wholesalers a fee for their distribution services, which forces bio/pharma companies to carry the entire inventory on their own balance sheets. With the wholesalers out of the picture, companies' principal tactics to reduce inventories are to cut back on purchases from suppliers and curtail their own manufacturing activities. This is wreaking havoc on CMOs, which are experiencing delayed and cancelled orders, and smaller orders to an unprecedented extent.

The problem has been noted by a number of CMOs during the past year, but the issue came into dramatic relief at the end of October 2009 when Lonza (Switzerland) warned of a substantial shortfall in expected revenues and earnings in a company press statement; the warning was brought about by a cascade of order cancellations and delays that started in late September and continued through October in both Lonza's biopharmaceutical and small molecule API businesses. Lonza CEO Stefan Borgas blamed the cancellations largely on working capital management efforts by customers and the reduced volumes forced Lonza to reduce its projected yearend profits (as measured by earnings before interest and taxes) by more than CHF 200 million (€132 million).

In its press statement, Lonza explained that: "This environment of high volatility is expected to continue for the next few years." As a result, the company launched an aggressive programme to counter the negative developments, including reductions in operating costs that it said would save CHF 60–80 million (€40–53 million) in 2 years and cutbacks in capital expenditures of more than CHF 100 million (€66 million) annually.

Silver lining?

CMOs are likely to face other challenges from these efforts to manage working capital, including having to wait longer to get their invoices paid. However, the potential impact of the inventory reduction drive is potentially catastrophic. As Figure 1 indicates, the major bio/pharma companies would have to reduce their inventories by another 50% to match the efficiency of Procter and Gamble.

We doubt that things will get quite that bad for CMOs; at most major bio/pharmaceutical companies, more product is produced in-house than at CMOs, so the inhouse manufacturing operations should absorb more of the impact, along with raw materials suppliers. However, as the Lonza announcement demonstrates, the transition period is likely to be painful for CMOs.

In fact, the focus on working capital may create opportunities for some of the most capable and savvy CMOs. Inventory control efforts include initiatives to produce to demand rather than producing to inventory. CMOs that can demonstrate the flexibility to respond to short-term ebbs and flows in product demand, rather than insisting on the traditional 90day lock in of orders, will prove themselves capable partners, which may lead to even more business opportunities. Should companies decide to close facilities as part of their ongoing restructuring efforts, those CMOs that can deliver product on short notice are likely to benefit.

Some of the best opportunities in business shaving occur as a result of extreme adversity. The inventory challenge is likely to be such an opportunity for CMOs.

Jim Miller is President of PharmSource and a member of Pharmaceutical Technology Europe's Editorial Advisory Board.