We have gathered together some thoughts on several hot topics around the pharma CDMO industry looking from a position that allows us to have a helicopter view.

The intention is to address topics and areas that we see gaps and malfunctions in the market and create hassle, cost and pain to the organizations.

We hope to provide food for thought that would trigger internal discussions on what and how could be improved

Opening the door to new customers in the CDMO industry

Sorry George, but we will not participate, we are a small CDMO and we have too many running projects at the moment”. This was a reply from the CEO of a small CDMO when I asked him if they would be interested in participating in one event, where Fuliginous Management Consulting has been invited to talk about CDMO landscape Trends and Pharma Co’s Outsourcing Patterns.

At the same time, we received positive feedback from other CDMOs that are somewhat a bit bigger or medium sized. And then I started thinking how a small CDMO located in central Europe is full of projects and they don’t have the interest in participating in an event which would also give them the opportunity to make several one-to-one meetings with prospects.

And then I started looking at the capabilities of this small CDMO and compare it with the capabilities of the midsize CDMOs. There must be something that this small CDMO does very well and maybe its competitors don’t do it. Fuliginous Management Consulting’s capability mapping for finished dosage forms for small molecules is so complete that it was easy for me to compare the manufacturing capabilities of different CDMOs.

So, I refreshed my memory about European CDMOs and their capabilities. Nobody forgets the big names of the industry that usually offer a big range of products such as solids, steriles, liquids, creams etc. But there are also small CDMOs out there that seem to be successful and kept busy. What can differentiate a small CDMO from the 330 others that operate in Europe and also offer CDMO services? Located in central Europe, costs cannot be much lower compared to competition. Customer focus might be higher than some bigger CMOs, but again it cannot explain how busy this CDMO is. Pricing (which is different than cost) might play a role in success but then again, pricing has to do with so many parameters (or at least should do so) that alone cannot guarantee success. Other factors like quality, delivery performance etc. are of course important but again, something else should make the difference. Good quality and delivery performance do not open the door to new prospects. They are important to keep customers in, but something else needs to bring them in first. And the same more or less goes for competitive pricing. It is important to open the door to a new customer, but first the new customer should knock at the door.

So, what makes a customer knock at the door and ask a CDMO if they have the capability to quote for a specific product? Being in this industry for almost 20 years, out of which the last 5 of them spent in understanding the CDMO market, my opinion is that small CDMOs can survive in this competitive landscape if they do something different and something better than the masses.

So, “Specialization” is the word I was looking for.

Many (almost 70%) of small molecules European CDMOs for finished dosage forms can produce OSD (Oral Solid Dosage) forms. And around 50% can produce Sterile products. But how many of those producing OSD can produce high potent OSD and how many of them can offer hot melt extrusion or spray drying? And from those producing steriles, how many have the capability of producing high potent steriles and sterile bags or PFS?

The answer to the above is that less than 20% of European CDMOs produce PFS, less than 7% offer high potent steriles and only around 5% can fill sterile bags. And the same goes for spray drying and hot melt extrusion. Around 5% of European CDMOs have these capabilities. If someone is looking for capacity in PFS, they will have a bigger choice since around 20% of European CDMOs can now offer them.

But what was this % some years ago? Not only for PFS but also for all the above-mentioned technologies? I cannot say for sure but definitely 10 years ago, you could not find so many CDMOs offering high potent OSD and prefilled syringes. The reason for this increase and the evolving number of CDMOs offering new technologies is of course the demand for such technologies.

Taking a look at the new drug approvals from the FDA during the last 5 years it is clear that there is a trend. New products entering the market are high potent, steriles, OSD difficult to be manufactured due to poor API solubility, lyophilized etc. Moreover, within sterile category, prefilled syringes % grows year after year. More specifically, new drug approvals in PFS accounted for 30% of sterile product FDA approvals in 2023 while in 2022 and 2021 the figure was 20% and before 2020 even lower. And the opposite goes for other technologies that used to prevail some years ago, but not anymore.

This means that CDMOs that understand the market trends and follow the demand, before competition, have a competitive advantage. CDMOs that specialize in certain technologies and are very good at it due to expertise, also have an advantage compared to competition.

Spending time and resources to build the right CDMO strategy for the future, certainly is something that will pay off eventually. Where to invest, what to expect from this investment in terms of revenue and profitability and what customers to contact, is something that is a requirement in today’s environment. Deciding to specialize in ampoules as opposed to PFS or lyophilized vials for example has some implications. Different technologies have different demand, require different pricing and bring different profitability. The profitability % that a CDMO should expect from producing conventional tablets should be less than this of lyophilized vials for example. And the opposite goes for the annual volume. Probably annual demand for conventional tablets is more than this of lyophilized products. So, you need to know what to expect in order to build the right business plan and strategy.

If as a CDMO you don’t do anything and just wait for a new trend to become mainstream, then you can reassure your boss that you do well in managing your risk but at the same time, you should manage expectations when it comes to growth and profitability discussion.

Being smart enough to invest at the right time in the right technology separates the best from the rest.

Year end Thoughts About Strategy in the Pharmaceutical CDMO industry

The end of the year is the time to put your thoughts together, look back at what happened over the last 12 months and make plans for the ones that will follow.

So, I was thinking of the discussions we had with our partners all these previous months, their worries, their plans, and the challenges they faced in the pharma CDMO industry. Some of them were simple, some of them more complicated but all of them generated interesting discussions.

There were questions about the industry such as what will be the needs of pharma companies in the near future, who are really our competitors, what are other CDMOs doing better than us, is our level of cost within the market range? And then there were questions about internal challenges certain people at the top management faced, like what is the right profitability measurement that we need to use in order to capture more efficiently the impact of new business and discontinuations. Or discussions about the strategy to be followed and how realistic the targets are when it comes to business plan expectations, both in terms of timelines but also of figures.

Finally, there are those discussions we had with pharma companies, that face problems with their current CDMO, they want to understand if what they pay to CDMOs is fair or they have other concerns like for example wanting to add in their pipeline a new product and they can’t decide if they have to develop it from scratch or to in-licence it.

Playing all these discussions in my head, different thoughts come to my mind. I think for example how difficult is to convince internally that from now on, on top of gross profit we need to start also looking at contribution margin for new quotations and this is because our manufacturing site is not underutilised any more and fixed costs are already covered by existing products. So, we don’t need to cover every time all our fixed costs and add on top a margin, especially when the customer is not ready to pay this amount. It might sound easy, but I dare you to try make this discussion with the CFO of a CDMO, who has set the profitability target for new business at 30% and overall EBITDA level of 15%.

Similarly, presenting to the board the impact of discontinuation of a loss making product, it is much trickier than it sounds. If the product is discontinued, but the direct labour cost related to it remains, what is really the impact? And if fixed costs of the site do not go down, what will happen to the profitability of other products that will remain in site? Will they have to absorb more fixed cost from now on? And then what will be the impact on their profitability? To me these are very interesting discussions but rarely people have the time to dive deep into the figures and make this analysis. Let alone that starting such a discussion may trigger other discussions about cost cutting. And nobody wants to start talking about this. So, unfortunately the convenient way of approaching the matter is to continue doing things the way they used to be done up until now.

Another difficult subject is to convince a board which intends to sell the company in the next years, that the 5 years business plan that is about to be created cannot be super challenging and unrealistic. Although it is nice to show to potential investors that in 5 years time, a CDMO can double its EBITDA, it is something that not all CDMOs can succeed in. Especially if the pipeline of new business is poor and new business will come from quotations that will be submitted in the future. But then, which Commercial Director or even which CEO will argue with the board that what you ask is unrealistic? The reply will be, if you believe that you cannot do it, we will hire someone who can. And so, second thoughts come to people’s minds and they avoid opening this subject.

Then, discussions about what price to give for new quotations and the strategy behind the pricing policy are the ones that intrigue me the most. Because there will always be this person with influence somewhere in the organisation who wants to standardize things. So, when the target for new quotations is for example set at 100 and profitability at 30, who will convince him that for the specific product that is about to be quoted with very high material cost, profitability cannot be 30 but it might be 15? Because if we stick to 30 it will be like adding 30% mark up on materials and this is something that is not acceptable by the market? So, is it better for the site which asks for new business to lose this opportunity and wait for the next, or is it better to provide a price with 15% margin and maybe win the business? And who will be responsible for this decision? Will it be the Site Head, the Business Development Director or the CFO? All of them have different priorities. Site head wants to add new business in the site as long as it is profitable, the Business Development Director wants to bring the customer in so to open the door for other new business also maybe for other manufacturing sites of the CDMO, and the CFO wants at least 30% profitability. If there is no common understanding and dialogue between them, then the one which is impacted negatively it’s the CDMO itself.

On top of all these, discussions about the growth strategy of a CDMO are also always interesting. How can we attract more new business, should we invest in Contract Manufacturing activity or into our own business (for integrated CMOs), in which technology should we invest. What the competitive environment that we operate looks like, what we can do better than our competitors, which are our direct competitors? I remember that when Fuliginous Management Consulting created the European CDMO Mapping including companies offering CDMO services, the number of companies in this database impressed me a lot. More than 330 companies offer CMO services for finished dosage forms of small molecules in Europe. Not, 100, not 200 but more than 330. This means that CDMOs that want to outperform should start adding more value to their customers in order to have some luck to increase their pipeline. And then discussions with our partners on what we can do better, where we should invest, what are the needs of the pharma industry start to take place. One way is to invest in new technologies that other CDMOs do not offer. Another way is to start offering services that we currently do not offer, like strong development capabilities. Because many CMOs have a “D” in their name, making them a CDMO, but how many of them can really develop a product from scratch? The truth is that not so many can do so efficiently.

But apart from the discussions we had with CDMOs over the last year, we also had discussions with pharma companies cooperating with CDMOs. Their main concern was to understand if what they pay for their existing products to different CDMOs is fair or if they can find synergies by negotiating prices or moving products to other CDMOs. Moreover, there are many pharma companies which suspect that the number of CMOs that they cooperate with, is big for the number of products they have in their portfolio. What is really the market average of the number of products vs the number of suppliers that a pharma company cooperates with? In a study that Fuliginous Management Consulting performed, the ratio of products / manufacturer has an average of almost 2.5. This means that a company with 100 products in its portfolio, cooperates on average with 40 suppliers. This was also a figure that impressed me, when I first found out.

And then we had of course discussions with several pharma companies, that wanted to outsource their production and they were puzzled to find the appropriate CDMO able to deal with the peculiarities of the specific product and having a good strategic match with them. The most interesting case last year, was a discussion we had with someone of the top management of a big VET pharma company who had asked more than 50 CDMOs if they can produce its VET, high potent, lyophilized product to be marketed in USA and all he got was negative replies. It was rewarding (also mentally) for us to find a solution for him, from a CMO that he had never heard before based in USA.

Approaching the year end, looking back but also looking forward, all these thoughts make me feel lucky that I have the opportunity to take part in such interesting discussions and being part of the solution. Politics inside organizations will never stop to exist, there will be different departments with different agendas and priorities, there will second thoughts in certain people’s minds but at the end of the day, all of those people work for the benefit of the organization. So, discussions around topics like the above should be made and progress will come only if people get out of their comfort zones. Strategic decisions should be based on information and having the knowledge of what the market is doing is something that always helps.

Pricing high value API products in the pharma CDMO industry. Trickier than it sounds

What is the right price to quote in order to win the business but at the same time secure profitability and avoid future surprises for our CDMO business? This is a question that probably everyone that has to provide a price for a new RFQ (Request for Quotation) has to answer.

This is not an easy question to be answered and this is because there are many ways to approach the matter, as well as different considerations that need to be thought of. But when it comes to high value API products (or expensive materials in general) pricing decision becomes more and more tricky.

According to Fuliginous Management Consulting there are 3 elements to consider before you decide what is the right price for a specific product. To increase the probability of getting the business with the highest possible profitability, all three elements should be combined.

  • Cost Plus (where a profit % is added to the cost)
  • Market Minus (what is the customer willing to pay for the specific product)
  • Competition (what other CDMOs offer for the same product or type of products)

The first one is the easiest to apply because the only thing that someone has to do is to add on the total cost of the product a predefined by the top management profit %. If for example the guidelines are to have profit of 30% for every new product, the pricing for the new product will be based on this.

But if the other two parameters are neglected then we might leave value on the table or our price might be too high and thus the probability of success will be low. So, define what the customer is willing to pay should somehow be estimated and there are different ways to do so. One way is to find the price of the product in the market of interest and calculate a profit for your customer which you think it will be satisfactory for them. Another way is to see what prices you have quoted in the past for similar products (API, technology, customer type etc) and have made it to production.

Coming to what competition is offering for similar products is very difficult to know and this is because you never know what strategy each CDMO applies. Consider that there are 2 CDMOs that compete for the same product in an RFQ process from a customer that is very promising and asks for a full cost price. The product is a 50 mg tablet and has a high API cost (lets assume 5000 euros per kg). This means that the cost of the API per tablet is 0.25 (250 per 1000’s tabs), while the remaining cost of the product is an average one (lets consider 20 euros per 1000’s tabs), similar to both CDMOs. Lets also consider that both CDMOs want to have 30% profit, but the difference between the two is that first CDMO applies a profit % on the total cost, while the second CDMO does not ask for profit from the API (he just adds some working capital cost and some production losses assumed combined at 10% of the API cost) and adds 30% profit on the remaining of the costs.

It is clear that the prices of the two CDMOs will be totally different. The price of the first CDMO will be 386 euros per 1000’s tabs while the price of the second CDMO will be around 306 per 1000’s tabs. If we assume that the annual volume is 10 million tablets the annual difference in the spend is 800K euros. If the annual volume is bigger, then the annual difference between the two CDMOs will be even greater.

Of course profitability of each CDMO will be very different. In the first case will be 30% (1.1 million euros per year for the 10 million tabs) and in the second case 12% (360K euros for the same annual volume).

If everything else is the same between the two CDMOs, the customer will most probably select the second one, since  the price of the first CDMO is 26% more expensive. The customer might also form the impression that the first CDMO is an expensive one in general, and this impression could lead in excluding this CDMO from future quotations.

But now consider the following situation. Two years later, when the transfer is completed and the product is into production in the second CDMO, something goes wrong, and a batch fails and needs to be destroyed or recalled due to fault of the CDMO. I wouldn’t want to be in the shoes of the CFO asking for the impact on profitability. Assuming 4 batches per year to produce the full volume, the annual revenue of the CDMO will be around 3 million euros and annual profitability as seen above 360K euros. The cost of the API per year is 2.5 million euros and since 1 of the 4 annual batches needs to be destroyed, the CDMO will have to pay from its pocket 625K euros. (annual cost of the API dived by 4). This is the profitability of almost 2 years, meaning that the CDMO will have to produce the next two years with zero profit in order to pay for the damage.

If the same happened in the first CDMO, with annual profit from this business of 1.1 million euros, the damage would be of course smaller. (Profitability would be decreased of course but the product would still be profitable in annual terms).

This brings to the table a dilemma. Which is the best pricing decision to make when quoting for high value API products? The one of the first or the second CDMO? Of course, there will be those arguing that adding 30% profit to the total business makes sense but on the other hand if there is competition who does not apply profit on materials, probably, business like this will never be won in the first place.

Is there a magic solution? Can someone guarantee that a batch will never fail? Mitigating such risk is necessary and certain actions can be taken, like increasing the quality level, strictly monitoring of processes, insurance for the API, etc, but if you were on the shoes of these two CDMOs, what would you do? Aiming for the new business from the promising customer or aiming for the peace of mind but decreasing the probability of getting the business?

It might depend on how much each CDMO wants to win the business and tolerance towards risk each CDMO has. It might also depend on the confidence each CDMO has in itself or even the financial security of each CDMO. And it definitely depends on the CDMO’s strategy for growth going forward. Furthermore, if a CDMO is already familiar with the product and its difficulty to produce, this might also help them taking the right decision. Finally, of course, it is also a matter of profitability measurement. On one hand there are CDMOs who set targets on profitability for new business considering their full cost including API and on the other hand there are CDMOs that measure their profitability as contribution on conversion (meaning profit expressed as part of the direct labour cost, where materials don’t affect profitability) and there are others in the between that add profit on materials but not as much as they do on their conversion cost.

But there are CDMOs which might not even think of such dilemma when quoting. These might be the ones with products with low-cost materials in their existing portfolio which may have not encountered such dilemmas in the past. There are also pharma companies cooperating with CDMOs that might not understand why offers received from two CDMOs for the same product can be so different.

This article hopes to give some food for thought to different stakeholders. Operating in the CDMO industry is not always easy and if pharma companies cooperating with CDMOs put themselves in the shoes of the first, cooperation will be easier. The same is true the other way around, putting yourself in the shoes of pharma companies builds stronger partnerships.

Being transparent also helps. If I was in the position of the first CDMO in the above example, I wouldn’t just provide a high price letting the customer make its own assumptions behind the reason. I would explain the rationale behind the decision, and although this might not be enough to win the business, it might not close the door to the customer for future RFQs. Likewise, if I was the customer in the above example, I would provide feedback to the first CDMO for its price (by the way this in not always done by pharma companies towards CDMOs) opening the discussion, and this might change the impression about the general competitiveness of the specific CDMO.

One thing is certain. Quoting for a new RFQ with high API value in the CDMO industry is trickier than it sounds.

Request For Quotation Management: The oxygen generator for CDMOs

Contract Manufacturing (CM) continues growing globally at a CAGR between 6% and 8% as different studies and reports indicate. This is partly due to the increase in the global pharma business (mainly NPIs) and partly due to the outsourcing increase by the pharma companies.

On the other hand, the CDMOs’ established business is continuously confronted by challenges coming from products maturity (volume churn, market withdrawals), market specificities (price pressures, cost increase) and customer strategy (insourcing, supplier consolidation), leading to year-after-year top-line and profitability shrinking.

It is more than obvious that CDMOs, independently of the strategy they follow (“Growth” or “Stabilization”), are doomed to look for new business. New projects’ introduction is the oxygen they need, at least for keeping the CDMO in the business, let alone to support growth.

The fact that any new business opportunity passes first from the Request For Quotation (RFQ) process of the CDMO, makes the RFQ management the oxygen generation engine, the quality of which will determine the short and long term company health.

The result of the RFQ process builds perception and provides valuable information:
•     Externally: Provides a strong indication to new but also to existing customers about the overall efficiency of the CDMO organization and the importance that the customer will receive from the CDMO.
•     Internally: Secures future sustainability, provides valuable information for Pricing policy efficiency, expected future pipeline and facilitates realistic but challenging internal targets setting.

An efficient RFQ process has to:

be standardized, fast and under control

• serve the CDMO strategy and facilitate profitable growth

• minimize offer preparation workload, facilitate project complexity management and monitor the process steps

• propose prices that increase probability of success and are within the desired/realistic profitability range

• provide competitive advantage and pass the right message to the customer

• facilitate statistical evaluation for strategic decision making

CDMOs (pure or integrated) have to make sure that the RFQ process gets the appropriate attention as it is one of the first cornerstones of their business and strategy sustainability.

The transformation journey of a manufacturing site from big pharma to a stand alone CDMO

There is a time in most peoples’ lives when they have to move from biking with support wheels to biking with 2 wheels. Apart from support, support wheels offer also stability, security and peace of mind. There is not much to worry about, you just have to move your legs and make sure you keep an eye on the road or the park. On top of this, usually a parent is with you to guide you and support you even more, whenever needed. When the time comes to get rid of the two additional wheels, a kind of transformation journey is required. You still continue to do the same thing (biking) but the challenges are many more. You need to adapt to the new reality, start focusing on different things, most important of which is to keep going since now you need to maintain a minimum velocity to stay upright. There is no support anymore when you turn, no guidelines from the parent when to break and this little rock or the sudden blow of wind can make you lose your balance. Let alone the fact that you gradually move away from the safe park and you start biking on the road.

To my eyes, the situation is similar when a pharma company decides to divest a manufacturing site and one fine day, instead of being part of a bigger family, the manufacturing site is left alone. Even if another CDMO acquires the site from the pharma company, it is often the case that it will remain independent with its own financial statements and resources. And although in such situations, during the first years of this transition, the site is protected (revenue protection, product volume protection etc.) this protection period is short. It can be three or four years, but this is not enough in the CDMO environment and the main reason is that in order to fill a site in three to four years you need to start preparing quotations now.

But it’s not only this. There are so many things that need to change in such situations. As it is the case when start biking alone on two wheels, a stand alone CDMO has no support or guidelines anymore from the parent company and no more secured business, and complexity increases dramatically. Instead of having to serve one customer, there is a need to start satisfying many more, instead of worrying about sticking to the production plan, attention to cost and profitability is required and among other things suddenly there is competition!

This means that there are many things that need to change in order to meet the new requirements and number one is the mentality. The mentality of the people working in the manufacturing site. And experience has shown that this is the biggest challenge of all.

Because it is difficult to change the mindset of people and explain that from now on they should be responsible for the profit and not just the cost, that OTIF should be at the same levels as this of the rest of the industry, that prices should be at the same levels as the rest of the industry and at the end of the day customers are those who pay their salaries and not the parent company anymore. From the moment that ownership changes hands, the people in the site need to start a journey; what I call a transformation journey.

But let’s deep into some details to understand the stages of this transformation journey. As mentioned above, one big change is that stand alone CDMOs need to bring in new business. And usually there is a reason that the pharma company decides to get rid of such manufacturing sites. It can just be due to a change in strategy, but it might well also be due to high cost, low utilization level, high investment requirements etc. So, if there is a manufacturing site with low utilization rate and with volume security (or revenue protection) for a predefined period of time, bringing in new business should be the number one priority. But its not only this. If costs are high and the new ownership wants to make profit, bringing in new business is not enough. You need to bring new business at the right price. The price that will allow good amount of new business to come in and at the same time to bring the desirable margin. And in order to do this, you need to know the market that you operate. You need to know what different customers are willing to pay for specific products and you also need to know what competition is offering.

On top of this, quality expectations should match those of your most demanding customer and delivery performance the same. As if this was not enough, as the years go by, the new owners will ask for growth. They will need to understand what is the cash flow, what is the expected profitability for the next 3-5 years, monitor the inventory levels, the working capital etc. They will even reach to a point where they will ask for cost savings! This does not necessarily mean layoffs, but it can mean that procurement department should make market research to find cost savings to raw and packaging materials, by negotiating with current suppliers or changing suppliers. The way of calculating the cost for new RFQs can be improved and the same goes for the pricing strategy and investment management.

Flexibility and customer service is another crucial area of attention. Form the very simple to the most complicated tasks. If competition provides a new quotation in two to three weeks, you cannot provide yours in a month. If a customer wants to split each batch to 5 different SKUs, you cannot afford to decline its request. When there is a failure in a batch and the customer is out of stock, you need to try your best to produce the batch again as soon as possible.

And then, there is contract management. As a stand alone CDMO, you need to make sure that your contracts protect and not harm you. You also need to be aware for contract clauses that enable you and for those that constrain you. And of course the entire organization should review a contract before it is signed and not just the legal team.

For all of the above to take place, new procedures and new tools will most probably be required. New KPIs, new monitoring systems and finally organizational changes cannot be avoided. There are dozens of new needs that have to be addressed and they need to be addressed fast, before existing volumes start moving out of the manufacturing site. And most importantly, all these changes need to be carried out without the support of a parent company. Just like starting biking with two wheels, except the transformation journey of a CDMO often proves to be a much more demanding challenge.

Private equity investment deals in the pharmaceutical CDMO industry. Separating the best from the rest. A fictitious story that teaches a lot.

Spring and summer is a great time to spend in Southern Europe, especially when all expenses are paid and you have given pocket money to spend. It was some years ago, when one family owned pharmaceutical CDMO, decided to change its ownership status from family to capital equity owned. And as it often happens, the private equity firm called the experts to have their say about the strategy to be followed and what should be expected.

The outcome of the first reviews and calculations was that this CDMO did not have a cost issue, it had a pricing issue. So, there was no need to visit the manufacturing sites, they would just take a look in the corporate functions and build the strategy. And specific attention should be paid to Business Development and Procurement departments. And this is what two well-known management consultants did. They spent their summer in Southern Europe and focused their attention to the corporate functions.

Long office hours, endless meetings, dozens of excel files, and the result was just great! A more than one hundred and thirty pages’ study and a more than one hundred pages new 5 years’ business plan were ready!

The Normalized cash EBITDA of the CDMO could fly from €10mio EBITDA, to €50-€60 million in just 5 years. The experts “sized a potential EBITDA upside of a great significance in 5 years from now”.

How? Very simple by approaching big pharma not yet in the CDMO’s portfolio, by finding additional opportunities among mid-sized pharma, by expanding in other geographies and technologies by saving in raw and packaging material cost due to higher annual volumes coming from new business, and the list goes on including other cost out initiatives of central management such as centralization of OPEX.

And of course, some prerequisites would support further the success story that was about to evolve in front of their eyes. A new pricing process, a new market intelligence team, new systems and tools, etc.

So, the solution was clear. Don’t change anything in the efficiency and the cost structure of the manufacturing sites, follow the above, and fasten your seat belt, you are ready for take-off!

So passengers sit, their seat backs and tray tables were placed in their full upright position and their seat belts were fastened. The flight attendances gave their guidelines for the take off and they… left the plane! The consultants were the first to leave.

The consultants left in the beginning of autumn and the same people in the middle management working only some months before for the family, were asked to begin transforming the company. The new owners, a big private equity venture, were happy and the journey began.

So, after the departure of consultants, people in the company started translating the business plan into actions. They started with the easy ones. And what is easier than kicking out some unprofitable business?

They started with a product which was well known of having negative EBITDA. And when someone from the top management raised the question how much is the positive impact that we have by discontinuing the specific unprofitable product, the answer was direct. “We earn the amount of EBITDA that we were losing before discontinuing itSo if we were losing €1 mio euros each year, the positive impact to the EBITDA is this amount”. Well… not exactly…

First of all, before answering this question, you need to understand in depth what does it mean “unprofitable product of €1 mio per year”

The second information you need to know to answer this question is what will happen to the costs associated with this product as soon as it is discontinued. Especially the fixed costs. Will they stay or they will be out too?

And this is where politics entered into the game. Business Development was arguing to operations that “I made what I had to make, I kicked out the product, now it’s your turn. Start cutting your costs linked with this product”. Operations did not want to cut their costs and finance was asking alignment between the functions for a common figure when it came to how much is the impact of the discontinuation.

Meanwhile the guidelines were clear. it’s OK to lose business, as long as they are not profitable.

To make the long story short, after two years, EBITDA was not increased and this was due to the fact that some business was discontinued, costs did not decrease and there was no time for new business to enter into the business. In the pharmaceutical CDMO industry, it takes time to quote, agree and transfer-in new business. And because of the new pricing policy dictating to quote with higher prices in order to improve profitability, it was getting more and more difficult to bring in new business.

And of course if two years from day 1 you are still on the same EBITDA level, with very limited new business agreements, there is no way to reach the 5 years target on time. As soon as it became clear to the top management and to the private equity investors that the target could not be met, pressure started to raise, the blame game began and of course the story could not have a happy ending. People in the top management, started one by one leaving the company and eventually the time came for the investors to start considering their exit with the minimum possible loss.

This was clearly an unsuccessful exit that was partly created by the unrealistic scenarios assumed in the first place. If the consultants that create the strategy do not have the expertise on the specific industry, and if the investors lack this expertise as well, it is easy to believe in something that an expert in the pharmaceutical CDMO industry could tell that is based on generalities and finally it is unrealistic.

It is no secret that private equity investors ideally look for high returns as soon as possible, but this has to be combined with the specific industry peculiarities. Of course there are opportunities for successful deals in the industry within 5 years window but specific market experience is required.

In order to create a successful exit strategy you need to have a realistic business case that convincingly answers the questions WHAT, HOW and BY WHEN and take actions that do not undermine the future of the company. In our case above, these questions were answered in an incomplete way.

  • WHAT: the general directions provided by the Consultants were not broken down to details.
  • HOW: not really touched upon.
  • BY WHEN: CDMO market peculiarities had not been taken into consideration.

It is not realistic for example to assume that unprofitable business (that cover part of the fixed costs and overheads) will be discontinued and the financial picture will get better. If you remove the revenue and you keep the cost, the picture will be worse.

If you increase your overheads because you need to make a more professional business development and finance team, you need to consider that you cannot wait for improvements in EBITDA in the first years. On the contrary, profitability may go down before it goes up again due to some preparatory work that might be needed. And before you decide to increase your pricing levels for new business, you probably need first to take into consideration the market that you operate. If a CDMO manufactures conventional tablets (along with hundreds of other CDMOs in this world) increased prices will lead to lower success rate in the new quotations, meaning less new business for the same level of submitted offers. If the strategy involves increased prices to existing customers (without considering contract clauses in place) it should also assume that some of those customers will decide to leave. And if this happens, a cost adjustment should take place, not only in direct but also in fixed costs. (in order for EBITDA to remain untouched)

Creating a business plan that sounds attractive to investors is easy. The difficulty lies on creating a business plan (including an exit strategy) that is aggressive but also realistic both in terms of financial expectations and timing.

Before suggesting to invest in a new technology, you need first to understand the competition and the overall market of this technology. It easy to suggest investing in soft gelatin capsules or blow fill seal but the proposal should include what is the competition of the specific market, what are the difficulties in the manufacturing process, how many potential customers are out there and what are they ready to pay for these technologies.

Do they currently outsource their products to other CMOs, do they produce them inhouse or they have in-licensed the products and they keep the production to other pharma companies which out-licensed the dossiers to them?

Before suggesting increasing the price level or the profitability expectations, a strategy should consider what type of products the CDMO offers and what is the market average in terms of price level and profitability for these products and not just for the technology type i.e. tabs or amps. In general, before estimating the growth potential of a CDMO, deep knowledge of the industry is required.

And the same goes for cost reduction opportunities. Even if many times neglected, cost is one of the primary factors for near future business sustainability, especially in technologies with increased competition. It is common that CDMOs see their profitability decreasing year after year. The main reason for this is poor cost management and limited or no actions taken addressing cost increases. Identifying the cost level through benchmarking, determine the reasons for cost increases and suggest procedures and actions for efficient cost increase management is necessary. This will illustrate where room of improvement lies, what and how much benefit could be targeted and what expectations investors should have before proceeding with the deal.

And of course business development mentality is also core to achieve growth. Industry experts can tell if a specific business development team works according to best practices and what (and if) room for improvement is there. Current processes and way of working, understand how customer focused the Bus Dev team and the supporting organization is, RFQ management and lead identification processes are items that is difficult to be evaluated by investors without the support of industry experts.

Separating the best from the rest when it comes to business strategies creation that will be followed by private equity investors is straightforward as long as people involved in their creation know what to look for. Part of the job of those who consult private equities is to manage their expectations and explain to them the real picture in order to avoid future disappointment. You cannot expect from investors to know everything about the business, but you should expect it from the market experts.

Pricing in the Pharmaceutical CDMO environment

Outsourcing the manufacturing of a product comes at a price. Sometimes metaphorically but always literally. What is the right price to pay to outsource your product? Who decides the price? Is it the CDMO who sells or the pharma company who buys? At the end of the day which factors affect pricing in the pharmaceutical CDMO environment?First things first. Price is different than cost and although sometimes they are related, it happens very often that they are not. This article tries to explain why this may happen and give some food for thought for different parameters affecting the price that a CDMO charges (or the pharma company pays to outsource the product).There are two perspectives of this topic. First is the angle of the CDMO and then there is this of the pharma company who outsources. Let’s start with the first one. When a CDMO offers a price for a product, probably the first parameter that considers is its cost. What is the cost of materials, the direct cost, the fixed cost etc. It is not uncommon that this is the only parameter that CDMOs take into consideration and this is what I call Cost Plus pricing strategy, where a cost is calculated and then a specific margin is put on top in order to calculate what price to offer. This is the easy but at the same time more simplistic approach, which sometimes leaves some money (value) on the table or in other cases may lead to rejection of the offer due to uncompetitive price. This is because the Cost Plus pricing strategy does not take into account market related factors.

Market related factors include what competition offers for the same product but also what the customer (the pharmaceutical company which outsources) is willing to pay for the specific product. It is the combination of three elements that should, in my opinion, be considered when a CDMO offers a price. CDMO’s internal parameters, Competition and Customer’s willingness to pay.

CDMO’s internal parameters should not include only cost related factors. There is so much more than the cost that should be considered. It was some years ago when I was about to propose a price to a customer which asked for a price without API. It was a low annual volume product (couple of batches per year), difficult to produce and API would be provided by the customer free of charge. During a meeting where we would discuss what price to offer, the CCO asked the question. What is the Value of the API? Since the API price would be provided free of charge, nobody had bothered to evaluate what was its cost. But it turned out to be that this was a crucial point because the API value finally was double than the value of the remaining batch cost. What would happen if a batch failed due to CDMO’s fault? It was calculated that if the CDMO had to pay for the value of one rejected batch, this would mean that not only the profit of one year would be evaporated but also CDMO would run at a loss. It doesn’t matter what finally was decided in the specific example. It feels to me that this is a nice example explaining that cost should not be the only parameter that should be considered when a price is about to be offered to the customer.

But of course, there are more. Free available capacity, difficulty of manufacturing the product, complexity, expectations of more business from the specific customer are some of the internal parameters that should be considered. It maybe the case that the CDMO charges a premium for a product that is difficult to manufacture, especially if competitors cannot cope with it. Similarly, if free capacity is limited, maybe it makes sense to charge a premium for giving away this limited free capacity. On the contrary, if the specific project is a door opener for a new promising customer, then it might be wise to consider sacrificing part of the margin, in order to bring the customer in. This of course is related to the strategy of each CDMO. Some have a growth strategy, for some others next year’s EBITDA is more important.

It is not the scope of this article to go into details. It is to give some food for thought and therefore further elaboration of internal CDMO’s parameters will be avoided. And this gets us to Market related factors.

Since what price competition is offering for similar products is difficult to know, unless maybe you ask for external advice, lets jump to what the customer is willing to pay for the specific product. CDMOs should, in my opinion, put themselves in the shoes of their customers for a while.

Is the customer willing to pay more because the CDMO has limited free capacity? Does the customer care if the CDMO has a growth or an EBITDA related strategy? Probably not, but maybe a difficult manufacturing process plays a role in the price that pharmaceutical companies are willing to pay. Of course there are more important parameters that the latter consider when deciding on what is a fair price to pay. The most important of which is what margin this price (which is a cost for the customer) leaves them on the table. And this is where it starts to get difficult for the CDMO. Defining what is the margin of the customer, letting alone what margin is enough for their customers might be seen as a long shot. Nevertheless, there are some ways to approach it. And the closer they get, the better the chances are for defining the right price for the product.

Is it the same if a product is a commodity like generic paracetamol tablets as if the product is an innovative lyophilized vial, patent protected? Manufacturing technology, therapeutic area, competition in the market of the pharma company (how many other pharma companies market this product) and country of sale are some of the parameters that affect what is the willingness to pay.

A good approach for the CDMO to define the margin that its price will leave to its customer, is to see what is the price of the specific product in the pharmacies in different markets, remove taxes, pharmacy margins and distributor margins and get a flavor of the margin that its customer will have. Of course this is not enough. Different pharmaceutical companies have different expectations on their margins but in general there are specific patterns. For a commodity like a generic paracetamol tablet probably something around 60% is fair enough. On the other hand, for an innovative lyophilized patented vial, they would expect something around 90%. These figures exclude rebates and marketing costs that pharma companies need to pay. If the CDMO does not consider factors like this, providing a price only based on internal parameters significantly reduces the chances to provide the appropriate price. Although it is difficult for many CDMOs to run this exercise, it probably worth the time and the effort.

Yet, margin is not the only factor affecting what is the willingness of a pharma company to pay. Culture, location, quality, cooperation, responsiveness and flexibility of the CDMO also affect customers’ willingness to pay. If the pharmaceutical company is satisfied with the service level they get from a CDMO, if they feel that they are important and their supply is secured, they are probably ready to sacrifice part of their margin as opposed choosing a CDMO with a lower price but also a lower service level and higher supply risk.

And of course, the better the pharmaceutical companies outsourcing their products are informed about what is the average price in the CDMO market for the specific product, the more ready they are to answer what is the fair price to pay.

Most pharma companies know that persisting in receiving a very low price from a European CDMO only because they want to keep their margins at a certain level, will not work in the long run. If the average conversion price in the European CDMO market is 2 cents for a simple tablet, asking to receive it at 0.5 only because they want to keep their margin above 60%, is not realistic.

Even if there is a CDMO that will accept to provide such price, in the long run this cannot be viable. His costs will continue increasing year after year and one day he will ask to change the price to a level which will be closer to the market average. Or, worse, he will inform the pharma company that he cannot afford continue producing it anymore.

So, answering the question what is the right price to pay (or to charge) it needs market knowledge. Knowledge of the CDMO market but also knowledge of the pharmaceutical market. CDMOs should put themselves in their customers shoes but the opposite is also true in order to have a healthy long-standing cooperation.

Knowledge of the market is important. Get to know your market but also get to know your customer’s market. Combining both will make you better prepared to answer the question of what is the right price in the CDMO environment.

Designing a new business plan in the Pharma CDMO industry. Are you ready to wait?

There are times in the life of an organization when the reset button needs to be pressed. It might be the period following a crisis or the change of ownership, in the aftermath of an acquisition or maybe when a new operation within the organization is about to start, or just because the growth and/or profitability rate is not on the desirable level. And this is when a new business plan is usually required. The new owners, the new Members of the Board, the new investors or the new CEO want to know what to expect for the next years. And as someone I worked with in the past used to say, it is important to know Who will do What, by When.And this is where the tricky part begins. The strategy and the business plan for the next years need to be structured by people who are familiar with the business. Experience has shown that it is not wise to trust experts from another industry or consultants that are generalists, to build your future. It is easy to say that in the next three to four years figures will explode but especially in the pharmaceutical CDMO industry it is not that simple.This article attempts to explain why and manage expectations of new Investors, Members of the Board or companies willing to start a new integrated CDMO organization within an existing organization. CDMO business is for those who can wait, and the reason is simple. All the effort that a CDMO puts now, all the new proposals it offers to customers, all new business agreed now, will bear fruits gradually in the future. This is because of the long timelines required for transferring in a product to a new manufacturing site and all the uncertainties coming with it. Moreover, before even reaching the transfer in stage, it takes time to prepare a quotation and to get a positive feedback from customers.

So, next time you hear someone building an aggressive business plan in terms of timelines and growth in the pharma CDMO industry, ask for details and look for realistic explanation. Important rewards should be expected at least 5 years later. Let’s see why with an example.

First let’s set some basic assumptions. Usually periods following a crisis, change of ownership, or attempts to set an organization from scratch require a reset. This means that limited or no new business has been agreed at time zero. Therefore, all effort starts now. And effort begins by providing new quotations to customers, wait for their response, and ultimately agreeing some new business. Then, begin the technology transfer, succeed in validation batches, perform stability studies, register to health authorities the new manufacturing site, hoping that everything will go according to plan. Only then the CDMO is ready to start producing the commercial batches.

The below example uses the following basic assumptions:

Target for revenue coming from new business is set to 100. Let’s see by when this target can be reached taking the below assumptions:

  • Each year the CDMO has the resources to submit quotations of 100 worth of revenue
  • Success rate of submitted quotations to customers is set to 20%. This is the average of the CDMO business as experience has shown
  • So, according to this success rate, each year the CDMO can agree 20 worth of revenue from new business
  • Completion time of transfer: 18 months
  • Revenue of new business agreed coming from routine productions will come gradually. In an optimistic scenario: 25% on the first year, 75% on the second year and only in the third year the full agreed revenue will be materialized. This is because in the first year, some limited revenue might be expected from validation activities, in the second year routine productions will not start in the beginning of the year, or not all SKUs will be produced (for a more complex project), and on the third year, assuming that all countries have been registered to health authorities and transfer is successful, full quoted revenue can be expected.
  • For simplicity reasons, no discontinuation of existing products will occur as well as current portfolio will have no fluctuation in the foreseeable future.

The below table shows how agreed revenue from new business will be materialized through the years.

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Due to the reasons described above, revenue will come gradually and as it shown by the table, total target of 100 cannot be expected to be achieved before year 6. Moreover, the total benefit from 5 years effort will come in year 7.

This is an optimistic scenario assuming that everything will go according to plan during the transfer process, and volumes agreed during the quotation phase (and subsequently revenue) will be unchanged. Experience has shown that many of the products that outsourced to CDMOs in the pharma industry are mature products with a tendency to lose market share as years go by. Therefore, it is not strange for CDMOs to see agreements made 5 or 6 years ago to be different than actual picture in terms of annual volumes and thus revenue. Furthermore, exactly because of the nature of the business it is also not strange for CDMOs to experience volume erosion of existing portfolio as years go by.

Nevertheless, the example used here assumes all other parameters to remain the same as in year 1.

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Of course, someone could argue that there are ways to bring the final target closer to year 1. The main two ways to do this is to increase either the number of RFQs (by increasing your resources to prepare and submit offers and your ability to identify more opportunities) or increase the success rate of submitted quotations to customers. The first one would increase your level of submitted quotations and the second one, the level of agreed business.

The first solution requires hiring additional people both within business development dpt. and maybe also in operations. Moreover, a more efficient RFQ management for faster responses can help. It might also require changes in the way of RFQ approach and move from reactive approach to proactive approach in RFQ management. This means that instead of waiting from customers to ask you for a quotation, find ways to provoke quotations requests than waiting to be asked for.

The second solution requires better costing and pricing policies. What the product that is about to be quoted should cost and what the customer is willing to pay for the specific product. Better understanding of what the competition is offering for the specific product types can also increase the success rate. In other words, move from cost plus to market minus approach.

The above example deals with the part of the business plan related to revenue evolution of the business. It has to be translated to EBITDA evolution for the coming years by estimating the Gross Profit of the new business and include any additional expected indirect cost on top (indirect personnel, promotion, exhibition participation etc). Investments down the road need also to be defined according to the adopted Investment Policy.

Summarizing, CDMO’s Top Management needs to comprehend the time parameter of the business, manage investors expectations and rely on a challenging but realistic business plan, based on production technologies and company strategy, developed by hands-on field experts within and outside the organization.

Furthermore, in order to secure successful business plan implementation:

  • Targets have to be set and achievements, towards the targets, to be monitored on monthly basis.
  • Clear Roadmap to be developed and Key Performance Indicators to be established for progress monitoring.
  • Progress toward business plan to be reviewed constantly and adjustments/changes on needed actions to be implemented if necessary, in order to remain aligned with the business plan.

Fuliginous Management Ltd specializes in the pharmaceutical CDMO business and its consultants carry many years of experience in this field. We know what it takes to increase both the level of submitted quotations and the level of agreed business by developing tools, models and processes tailor-made for our customers’ needs. In other words, We know What to do by When in order to make a CDMO succeeding in securing profitable organic growth.

If you are ready to design your next business plan, get in contact and we will build together an ambitious, realistic and achievable business plan that will not need adjustments every year since it will be based on solid assumptions, clear steps, measurable actions and KPIs.

Defining the right Profitability Measurement in the Pharma CDMO industry. Easier said than done

Profitability is a topic which takes the lion’s share of discussions within business environments. “Profitability last year was not as expected, profitability of this new project is not high enough, that product has a negative profitability ” etc.

Every CEO, every business development vice president, every business unit head, let alone the CFOs, discuss it with their boss all the time. And even if the overall company’s profitability is the top of the iceberg and it is measured by EBITDA % over revenue, the question remains of how the profitability should be calculated for potential new projects in case they are incorporated into the company’s business i.e., how the new project will affect the company’s bottom line.

Adopting the most representative measurement in the effort to predict the profitability impact of a new project, is vital for facilitating managerial decisions that are aligned to the specific CDMO business strategy.

I’ve taken part in numerous discussions in the past with different CDMOs of the pharma industry, trying to determine which is the most realistic way to measure profitability of a new product that is about to be quoted. To answer to this question, the CDMOs need to determine what costs should be taken into consideration. And in many cases, this is much more complicated than it sounds. At one extreme there are examples of CDMOs that add to the cost all direct, fixed costs and overheads of the company (somehow allocated) and at the other extreme there are CDMOs who include only direct costs required for the production of the specific product.

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Apart from the direct costs associated with the production of the product (direct labour and materials) should we add to the cost part of the equation, fixed costs and overheads? And if yes, which of the fixed costs and overheads? In the above, simplistic example of an imaginary product, is the profitability 50% or 0%? Or maybe 25%? Is there a golden rule of calculating profitability that fits all CDMOs? If the above figures were the figures of a new product awarded to a CDMO, would this be a profitable business or not? Would the CFO and the Commercial director be happy with this? (if ever Finance and Business Development manage to agree on something)

Instead of trying to answer to these questions, let me put some more questions on the table…

  • Does the manufacturing site of the CDMO runs at full capacity or is it more or less empty?
  • Does it already cover its existing fixed costs?
  • Does the new product require additional investments in order to be produced or is it a plug and play one?
  • Can the new product be produced with the existing indirect resources of the site?
  • Is the overall company strategy a short term one (2-3 years) or a long term one (3-7 years)?
  • Is the CDMO a listed company or a family owned business?

Some of the above questions may sound irrelevant to the initial dilemma (i.e. which is the most appropriate way to express profitability), but in reality they are not. In fact, it matters for example if the CDMO belongs to a fund whose goal is to sell the company in the next 3 years in a price that is multiple times of its EBITDA. This is different from a CDMO belonging to a family whose main goal is to increase volumes and revenue. This is because in the first case an increase of 1million in EBITDA will result in 10 million maybe, in the pocket of the fund (due to the fact that they can sell the company 10 times more than its EBITDA) while in the case of a family-owned business, an increase of 1 million in EBITDA will stay as is if there is no vision to sell the company. Therefore, if this was the only factor affecting the decision of which is the best way to measure profitability (which is not), the CFO of the first CDMO would insist that every new product entering the site, should cover all allocated overhead costs (and generate EBITDA increase with every new product), while the CFO of the second CDMO might be happy if only fixed allocated costs were covered.

But, since the structure of the CDMO is definitely not the only factor affecting the most appropriate way to express profitability, let’s see how other factors contribute to the decision.

Let’s assume that a pharma company has requested from two different CDMOs to confirm if they can produce product X at a given target price of 100.

Below there are some assumptions for each of the CDMOs. They are extreme cases, for the sake of argument.

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In the case of CDMO 1, the new product will not add additional fixed costs, will not require additional investments and its capacity utilization is quite high, meaning that its current fixed costs are already covered. Moreover, the process for CDMO 1 will be 100% manually, meaning that no machinery will be used for the production of the product. Finally, there are small general overheads and the equipment in house is old and therefore already amortized and paid off.

For CDMO 2, everything is opposite.

If both CDMOs have the same direct material and labour cost for this product (let’s say 50), both of them will have a contribution of 50%. (Contribution = Unit Price – Direct Cost). However, CDMO 1 does not need to cover any existing fixed costs (due to the 80% capacity utilization) while CDMO 2 cannot afford to add products in the site if they do not contribute heavily to the fixed cost absorption.

Similarly, CDMO 1 does not have to worry about financing increased fixed costs as well as investments required for this product, while CDMO 2 does. Finally, the fact that the general overheads are low for the CDMO 1, probably means that the salaries of the corporate team have already been covered by the existing products. For the CDMO 2, which is much bigger with higher general overheads and recent investments into equipment made, new products entering the site(s) should not just cover their cost but also heavily contribute to the absorption of general overheads.

Considering the above, CDMO 2 in his profitability calculation should take into account the high fixed costs he has to cover. Hence, a gross profit calculation, that helps him to do so is very much needed. (Gross Profit = Unit Price – Direct Cost – Fixed Cost)

The above extreme example presents two different profitability measurements, Contribution and Gross Profit. If CDMO 1 decides to use purely the Gross Profit measurement, inevitably in his attempt to do so, will allocate part of the fixed costs to every new product that will enter into the site. If for example the CFO sets a target of 20% Gross Profit for every new product, this means that price should be 25% more than the sum of direct and fixed costs of the product. (because if direct and fixed costs equal to 80, a price of 100 would lead to 20% gross profit, but 100 is 25% higher than 80).

However, if fixed costs have already been covered or are zero for new products (in the extreme above example) this will lead to a false cost calculation and wrong profitability figure. There is no point in measuring Gross Profit in this case. Contribution is a much preferable measurement as it focusses on the direct cost and gives a profitability picture much closer to reality.

To put it in another way, if fixed costs do not really change with the addition of new products, Contribution is a more appropriate reference. If on the other hand, CDMO 2 starts measuring Contribution and forgets about fixed costs and Gross Profit, it will find himself very soon with a full manufacturing site that probably does not cover its fixed costs.

The same is true not only for new products but also for discontinuations of existing products! If a big volume product is discontinued, its negative effect on the site is much higher than its current Gross Profit, in case fixed costs do not decrease accordingly. Imagine for example that an existing product with annual Gross Profit of €20K and annual Contribution of €50K is discontinued. If fixed costs do not go down (and usually this is the case), the negative impact on profitability is not just the €20K per annum. The Contribution should be measured as a loss in this case (depending also if direct labour costs will be removed or not).

Even more attention should be given to negative Gross Profit products that are discontinued. Let’s assume that a minus €20K Gross Profit product has a positive €30K annual Contribution. If this product is discontinued, the effect that will have in the overall picture of the site (if fixed costs do not go down) will be negative at least by €30K and not positive by €20K.

Probably keeping an eye to both measurements makes sense and there is no golden rule that fits all cases. Neglecting one of them completely is also false.

So, next time that you are about to calculate the impact on profitability of a new product or a product that is about to be discontinued, be careful on what measure you will use. Similarly, when setting targets for profitability of new products, think twice which is the most appropriate measurement for your company. It might sound easier said than done, but it does worth the effort to put some thought on it.

External Manufacturing Network of Pharma companies without own-manufacturing facilities

“…do we work for our company’s benefit as well or just for the benefit of all other parts of the supply chain industry…?”

Commercial Pharma Companies

Out of a sample of 320 pharma companies operating in Europe and listed in our database, more than 120 do not have own-manufacturing activity, focusing mainly in commercializing products. The vast majority of these Commercial Pharma Companies (CPCs) market traditional technology products that face increased competition in the market.

Not having manufacturing capabilities CPCs rely exclusively on their External Manufacturing Network for having their products ready for sale.

How External Manufacturing Network looks today in CPCs?

The products that CPCs market, come from in-licensing, product acquisitions or own product development. In-licensing seems to be preferred to the other two models since it allows fast market entry, limited initial investment and manageable risk for the first years of product commercialization. On the other hand it lags behind the other two in product Gross Profit (GP) margin, flexibility in future product changes and manufacturer selection as well as in the company’s valuation for the future.

For all three models, at the time of the deal/decision the Gross Profit of the product is supporting the business case and this is usually the case for a number of years. As time passes, product commercialization cost as well as product supply cost increase (supplier price increase requests, additional requirements from authorities, …). On the contrary prices stay flat or decrease resulting, after a period of time, to product Gross Profit shrinkage well below the product category market average. This is the time when stockholders question themselves:

“…do we work for our company’s benefit as well or just for the benefit of all other parts of the supply chain industry…?”

The drop in GP, at a point in time, raises question marks if it really makes financial sense to keep commercializing the product and also creates unpleasant thoughts about the survival of the company in the future. These concerns oblige CPCs to escape forward by introducing new products with better GP (than the existing ones) in order to keep an acceptable EBITDA for the company. This is a non-ending cycle since the new products GP will again shrink after a period of time.

Unavoidably, the increase in the number of products of a CPCs leads in adding new suppliers in the list that subsequently increases complexity and administration cost. Also risk management becomes more and more an important parameter for the business going forward.

After examining a number of products (917 products for which information could be found online) of a relatively small sample of CPCs (20), the three major findings are:

Diffusing a given business to a big number of suppliers deteriorates CPC’s weight per supplier. This may lead to limited attention from supplier’s side towards the CPC.

Having a big number of suppliers for products of the same product technology could make the loss of opportunity more intensive since potential synergies are also not obtained.

Using suppliers for which contract manufacturing is not a core business may lead to limited flexibility, less competitiveness for the product and higher risk for being in a position to find a new home urgently at a point in time.

The External Manufacturing Network situation, as described above, seems to be mainly a result of the combination of three factors:

  • All attention of the company is given to increase the top line without really managing the cost
  • In-licensing model
  • No organized effort in optimizing existing suppliers network

Does this mean that CPCs should stop focusing in top line growth and in in-licensing? Definitely not! This should continue according to the company’s strategy. At the same time though network optimization should take place and an Outsourcing strategy has to be established to support a sustainable growth.

 Does External Manufacturing Network optimization worth the effort and investment?

So, if there is important value to be gained in suppliers’ network evaluation and subsequent optimization, why such a project is not one of the top priorities in the CPCs?

The main reasons are:

The potential benefit is not clear due to lack of benchmarking information. A business case cannot easily be created based on cost / benefit analysis. This creates hesitation in occupying resources and initiates a project with unknown outcome.

There are uncertainties related to potential product transfer difficulties that could not be foreseen from the beginning. This is true with old product files with vague process descriptions and for which a transfer process could trigger additional requirements by the authorities.

Fear to spoil the relationship with current suppliers is involved. Good relationship with suppliers is of high importance and there is a fear that “difficult” discussions would harm the relationship especially if some other products remain with the suppliers.

Contracts include obligations or clauses that limit CPC freedom to select supplier of choice. This is usually the case with in-licensed products.

Supply portfolio risk evaluation is not performed and thus related risk is not realized.

Suppliers’ network evaluation and optimization program, addressing the uncertainties mentioned above, could deliver a number of important benefits:

– External manufacturing annual spend reduction between, indicatively, 10% and 15%

– External manufacturing network risk management and risk mitigation

-Lower internal cost for efficiently managing suppliers

-Increase company’s weight on fewer preferred suppliers

The answer to the question in the title of the paragraph is YES if it is based on solid business cases that take into consideration real market assumptions.

 What should be done and how?

The most decisive step is the thorough evaluation of products and suppliers.

-Product Price benchmarking would define products with higher price than market average.

-Analysis of product category GP and comparison to market average would indicate areas of attention.

-Product restrictions due to contract clauses should be taken into consideration.

-Supplier evaluation based on criteria according to company’s strategy would show preferred or high risk suppliers.

Combining the outcome of the above analysis, a number of product bundles would be identified as business cases either due to high price / low GP or because of high risk suppliers.

Cost / benefit evaluation of the business cases, based on clear assumptions according to market standards, will rank them according to expected overall benefit and define the action plan and priorities going forward.

In the implementation phase, assumptions should be tested and, if necessary, modifications of the business case should be done before proceeding with the change implementation.

As companies grow it is inevitable that new products and suppliers will be added to the list. Having a clear outsourcing strategy and running a product and network review, within specified intervals, is the recipe for achieving and keeping an optimized External Manufacturing Network.

 

Master Data Management in the Pharma CDMO business. Neglected but necessary

What do you mean you don’t know how many packs of Product Family X we sold last year from our 3 manufacturing sites?” asked the supply chain director, of a midsize CDMO, her team?“Well, it is not so easy to reply to this, we will need some time. You know, every manufacturing site does not use exactly the same name for this product let alone that different markets (SKUs) have slightly different names for it. So, we will need someone who knows what products are included in this family and also some time and manual work to group them together and to gather this information”.At the same time, in another meeting room in the headquarters of the CDMO, the CFO asks his team to inform him about the revenue and profitability of the top 10 sales products and their evolution since last year. Therefore, one member of the finance team has to communicate with the 3 manufacturing sites, ask for this information, maybe clean up what he/she will receive and finally put it in the format that the CFO expects to see.

Reading the above, one can argue that there is nothing difficult with the above tasks. And in reality, indeed, there should not be. However, imagine this. One of the products in the above questions is Ibuprofen for customer X in three different manufacturing forms: Tablets, syrup and suppositories. Each of them is produced in a different manufacturing site of different countries. Experience has shown that a Spanish site can name such SKU like “Ibuprofeno”, a German Site may use the English term and call it “Ibuprofen” while a French site may spell it Ibuprofene. At the same time one SKU in 1 country may be spelled differently than in another country.

And it is not only Ibuprofen. Take its rival, Paracetamol for example. When I first heard about Acetaminophen I didn’t know that it was the same with Paracetamol. So, when I was asked to split the volumes of a specific customer in different products, I separated Paracetamol from Acetaminophen SKUs. And the same happened to me, when I was asked to look if we produce Vitamin C products in the company. I looked for Vitamin C, but I didn’t look for Ascorbic Acid. Nobody told me that they are the same.

If there is a system in place to group all Ibuprofens (including those with an “e” or an “o” at the end) together, and to tell people that Paracetamol is the same as Acetaminophen, and Vitamin C the same with Ascorbic Acid, life will be easier for those who want to look at the big picture. And it might be sound easy for those who work in the manufacturing sites and deal with them every day, but corporate people in finance or business development are not familiar with such things. So, when their boss asks them to gather together such information, they need more time than they should, to answer such simple questions.

The same problem, if not more intensive, is confronted when it comes to raw materials. How easy and accurate it is to report what our total spend on a specific material is, how many suppliers do we have and what the potential benefit would be in different scenarios evaluation?

And then it is not only the terminology. There are also human mistakes that happen every day. Someone can spell Allopurinol, Alopurinol (by missing 1 of the 2 “l”s). Or someone in one department spell instead of GSK, GlaxoSmithKline for example. Or one department spells Teva and another Teva Pharmaceuticals. Let alone that Actavis belongs to Teva now so if someone wants to find the sales towards Teva, he should probably also include Actavis SKUs in his calculations.

Here comes Master Data Management (MDM) whose definition in Wikipedia is “a technology-enabled discipline in which business and Information Technology (“IT”) work together to ensure the uniformity, accuracy, stewardship, semantic consistency and accountability of the enterprise’s official shared master data assets”.

In other words, we need Master Data Management in order to make sure that there is a common rule between all 3 different manufacturing sites that says that whatever way the Ibuprofen SKUs are spelled in the artwork of the box, in our ERP system we will have a field that it should mention that all of them belong to “Ibuprofen” family. And the same for Paracetamol and Acetaminophen. When someone from the top management asks what is the total revenue, profitability or volume in bulk units of Paracetamol, the system should gather together this information with 1 click. And then with MDM nobody will be allowed to spell GSK, GlaxoSmithKline in our ERP system anymore. There will be a drop down menu somewhere which will only give you the option to select GSK.

I know that most of the above examples do not apply to small companies with 1 manufacturing site and 10 or 15 products, but for pharma companies with a bit more of complexity it definitely worth the time and the effort to try MDM. Even if it does not seem necessary now, if there is a vision to grow the company, MDM will become a necessity very soon. So, it is better for people in the mid sized companies to be familiarized with this.

Especially family-owned businesses that want to grow and maybe acquired by a private equity in the future, this is something that will definitely be required. People in private equities are usually not familiarized with the specific business and that is why they ask a lot of questions. And the more questions are raised, the more important Master Data Management gets.

It is not the simplest task in the world and definitely people inside the manufacturing sites who only look the picture of their site will not agree that this is necessary, because everyone knows the Ibuprofen SKUs and everyone knows that Acetaminophen is Paracetamol. So, they don’t need a system to tell them how to group the products. And it takes time to classify SKUs and to fill so many fields in the ERP system. So, why to do it?

And here lies the problem. Those who need Master Data Management are different people than those who need to feed the system in order for MDM to work. If the person who creates the SKU into the ERP does not fill at the time of the creation all the necessary fields, the corporate person who needs to answer to the questions of the CEO or the CFO, will never be able to see the advantages of MDM and he will be forced to group things manually and make assumptions where he is not sure.

I still remember, many years ago, the saying of our IT Director: “garbage in – garbage out”. He meant that the quality of information that you will retrieve from your ERP system will be the same with the quality of information you input to the system.

Important managerial decisions but also strategic decisions are most of the times based on trends and historical data and this kind of information needs to come fast and to be accurate.

This is why a corporate policy needs to be defined, where a RACI table will clearly mention who is responsible for what and ERP systems should have rules to secure that an SKU will not be created if certain fields are not filled. But something like this needs to come from the top. Directors of different departments (IT, Supply Chain, Operations, finance, business development, purchasing etc.) should agree that this is an important task and collaborate in order to establish a Master Data Policy. It will never look like a priority because everyone has its own everyday fires to put out, but if this works, the amount of time and mistakes that will be saved will be enormous.

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