Shareholder Representative Services, LLC v. Alexion Pharmaceuticals Inc.Shareholder Representative Services, LLC v. Alexion Pharmaceuticals Inc.
Michael A. Barlow, QUINN EMANUEL URQUHART & SULLIVAN, LLP, Wilmington, Delaware; Andrew M. Berdon, Angus Chen, Alexandria Deep Conroy, Courtney C. Whang, QUINN EMANUEL URQUHART & SULLIVAN, LLP, New York, New York; Joseph M. Paunovich, David M. Elihu, James Bieber, Andrew Brayton, QUINN EMANUEL URQUHART & SULLIVAN, LLP, Los Angeles, California, Attorneys for Plaintiff and Counterclaim Defendant Shareholder Representative Services LLC.
David E. Wilks, Scott B. Czerwonka, WILKS LAW, LLC, Wilmington, Delaware; Deborah E. Fishman, Carson D. Anderson, ARNOLD & PORTER KAYE SCHOLER LLP, Palo Alto, California; Daniel L. Reisner, Jeffrey A. Fuisz, Angela R. Vicari, Matthew M. Wilk, ARNOLD & PORTER KAYE SCHOLER LLP, New York, New York; Howard Sklamberg, Jeremy Cobb, ARNOLD & PORTER KAYE SCHOLER LLP, Washington, DC, Attorneys for Defendant and Counterclaim Plaintiff Alexion Pharmaceuticals, Inc.
Defendant Alexion Pharmaceuticals, Inc. purchased nonparty Syntimmune, Inc. to develop a drug to treat rare diseases. The merger agreement promised discrete lump sum payments to Syntimmune’s former stockholders upon the achievement of development milestones, and obligated Alexion to use commercially reasonable efforts to achieve those milestones. The agreement designated plaintiff Shareholder Representative Services, LLC (“SRS“) as the former Syntimmune stockholders’ representative.
Alexion terminated the drug development program. SRS sued for breach of the efforts obligation. After trial, I concluded Alexion had breached its efforts obligation by terminating the drug development program.
With the benefit of supplemental briefing, this opinion addresses the expectation damages Alexion owes for that breach. Because the earnout provision provides for lump sum payments for contingent events, this decision employs an expected value approach. It calculates damages by weighting each milestone’s earnout payment by its probability of success, discounted to present value at the time of breach. It calculates that SRS is entitled to $180,944,915.32 in damages for Alexion’s breach of its efforts obligation, plus pre- and post-judgment interest.
I. BACKGROUND
This decision relies on the factual findings set forth in the post-trial opinion on liability (the “September Opinion“) and the trial record.1 The facts set forth herein were proven by a preponderance of the evidence at trial.
A. The Syntimmune Merger And Earnout Agreement
In September of 2018, Alexion acquired Syntimmune to develop and commercialize a monoclonal antibody that became known as ALXN1830.2 The purchase price included $400 million up front and $800 million in earnout payments tied to eight development milestones.3 Milestone 1 provided for a $130 million payment upon the completion of a successful Phase 1 Clinical Trial, as defined by the Merger Agreement.4 The September Opinion concluded Milestone 1 had been achieved, held Alexion breached its contractual obligation to pay SRS $130 million upon achievement of that milestone, and awarded damages in that amount.5
| Earnout Provision Summary for Milestones 2 Through 8 | ||
|---|---|---|
| Milestone | Milestone Amount | Triggering Event |
| 2 | $ 120,000,000.00 | First dosing of the first patient in a Pivotal Clinical Trial for any first Indication. |
| 3 | $ 120,000,000.00 | First dosing of the first patient in a Pivotal Clinical Trial for a second Indication. |
| 4 | $ 150,000,000.00 | Receipt of Regulatory Approval from the FDA for any first Indication. |
| 5 | $ 150,000,000.00 | Receipt of Regulatory Approval from the FDA for a second Indication. |
| 6 | $ 25,000,000.00 | Receipt of Regulatory Approval from the EMA for any first Indication. |
| 7 | $ 25,000,000.00 | Receipt of Regulatory Approval from the EMA for a second Indication. |
| 8 | $ 80,000,000.00 | The determination at the end of Alexion’s fiscal year that the Net Sales for such fiscal year across all Indications equals or exceeds One Billion Dollars ($1,000,000,000). |
The Merger Agreement provides that Milestones 6 and 7 “shall be achieved upon receipt of the applicable reimbursement and/or pricing approval from the applicable Governmental Entity in three (3) out of the following five (5) countries: United Kingdom, France, Italy, Germany or Spain.”7 Each milestone payment is due forty-five days after the milestone’s achievement.8
To propel ALXN1830 toward those milestones, the Merger Agreement required Alexion to use Commercially Reasonable Efforts (“CREs” and the “CRE Obligation“), as defined by the agreement for seven years.9
This opinion defines a “Milestone Event” as the achievement of each milestone, noted in the form Mi, where i represents a given Milestone Event number. This opinion notates the probability of a Milestone Event (each a “Milestone Probability“) as P(Mi). This opinion also deals with conditional probabilities, that is, the probability that an event will occur given that some other event occurred. It notates the probability that a later Milestone Event will occur given that an earlier Milestone Event occurred as P(Mi|Mj). For example, the conditional probability of M3 given M2 is notated P(M3|M2).
B. Syntimmune’s Largest Former Stockholder Values Its Right To Milestone Payments.
Shortly after Alexion acquired Syntimmune, Syntimmune’s largest former stockholder Apple Tree Partners (“ATP“) valued its right to future distributions from Milestones 2 through 8 based on the milestone amounts and probabilities of achievement.10
| ATP Milestone Probability Estimates | |
|---|---|
| Milestone Event | Probability |
| M2 | 0.80 |
| M3 | 0.75 |
| M4 | 0.53 |
| M5 | 0.45 |
| M6 | 0.53 |
| M7 | 0.45 |
| M8 | 0.1012 |
C. The ALXN1830 Program
Alexion initially focused the ALXN1830 program on the PV, gMG, and WAIHA indications.13 But ALXN1830 faced significant development obstacles after the merger, including a contaminated drug supply and adverse patient reactions that forced it to pause several clinical trials.14 The emergence of COVID-19 halted all of Alexion’s trials, while its competitors were able to push ahead.15 In April 2020, Alexion
But the program regained some momentum. In March 2021, Alexion began dosing in a Phase 1 trial in healthy volunteers called HV-108.18 Alexion also planned Phase 2 studies in gMG and WAIHA, even though it was clear ALXN1830 would be later to market than originally anticipated relative to its competitors.19
In July 2021, Alexion was acquired by AstraZeneca plc.20 AstraZeneca had promised its shareholders $500 million in recurring synergies from the acquisition, so Alexion launched a full portfolio review of its drug programs.21 Soon after the merger, Alexion deprioritized the ALXN1830 gMG and WAIHA programs in favor of TED and cAMR.22 None of Alexion’s competitors were pursuing TED or cAMR treatments, so Alexion believed it could be the first to market in these indications.23
Alexion used an internal metric for probability of technical and regulatory success (“PTRS“) “as a guide” to assess its programs.24 PTRS has two components: probability of technical success, and probability of regulatory success given technical success.25 Overall PTRS is found by multiplying the two components and maps onto the probability of FDA approval from the outset.26 Shortly before receiving HV-108 data, Alexion estimated its cAMR program had a 50% chance of a successful Phase 2 study.27 Alexion set the cAMR program’s
In August 2021, HV-108 was paused due to a COVID-19 outbreak.31 Alexion received preliminary data from the paused study in September. The data showed a high immunogenicity rate,32 but that was not news to Alexion.33 A preliminary assessment from the day the data was received showed there was no impact on an important efficacy indicator, and the “safety profile remain[ed] unchanged.”34 But by the next day, “the current view [at Alexion was] that development of 1830 [was] going to be stopped.”35
Alexion received additional HV-108 data in November. An outside consultant Alexion hired to analyze the data concluded that the “detected ADA response d[id] not appear to compromise overall benefit vs. risk,” and there was “an adequate weight of evidence to resume study HV-108.”36 But Alexion had made up its mind about ALXN1830. In response to the HV-108 data, Alexion reduced TED’s probability of a successful Phase 2 study from 43% to 20%,37 and reduced TED’s overall PTRS from 30% to 10%.38 Alexion also reduced cAMR’s overall PTRS to 10%.39
Alexion decided to terminate the program on December 14, 2021.40 The September Opinion held that breached Alexion’s CRE Obligation.41 The September Opinion determined “[t]he preponderance of the evidence supports the conclusion that the decision was influenced, motivated by, or driven by AstraZeneca’s pursuit of merger synergies.”42
D. Dr. Michael Kinch’s Testimony
At trial, SRS’s antibody development expert Dr. Michael Kinch opined about the probability of achieving Milestones 2 through 5 had Alexion used CREs. Kinch offered calculations based on his open-source database “of experimental medicines and their likelihood of being approved” called the Clinical Drug Experience Knowledgebase (“CDEK“).43 Kinch built CDEK to provide a database for academics who could not afford the high subscription costs of the private databases pharmaceutical companies use to evaluate
Based on his comparisons to similar molecules in CDEK, Kinch estimated the probability of M2 was between 0.582 and 1.47 He opined that the probability of M4 given that M2 occurred was 0.684.48
Kinch opined the probability of M3 given that M2 occurred was equal to the initial probability of M2.49 Similarly, he opined the probability of M5 given that M4 occurred was equal to the probability of M4.50
Kinch’s relevant opinions are summarized below:
| Kinch’s Opinions Based on CDEK | |
|---|---|
| Opinion | Notation |
| The probability of M2 is between 0.582 and 1. | 0.582 ≤ P(M2) ≤ 1. |
| The probability of M4 given that M2 occurred is 0.684. | P(M4|M2) = 0.684. |
| The probability of M3 given that M2 occurred is equal to the probability of M2. | P(M3|M2) = P(M2). |
| The probability of M5 given that M4 occurred is equal to the probability of M4. | P(M5|M4) = P(M4). |
E. John Russell’s Testimony
John Russell was SRS’s expert on the evaluation of the pharmaceutical competitive landscape, market opportunities, and commercial potential and pricing and reimbursement.55 Russell testified that if ALXN1830 received EMA approval, it was likely to receive the country-specific approvals to satisfy Milestones 6 and 7.56
Russell also testified, based on Alexion’s 2021 global revenue projections, that ALXN1830 had the potential to achieve Milestone 8 if it obtained approval.57 The Alexion model he relied on forecasted a peak of $1.35 billion in combined annual revenues for TED and cAMR, and revenues over $1 billion for the same two indications in four more years.58
II. ANALYSIS
SRS pursues two alternative paths to damages regarding Milestones 2 through 8. SRS seeks damages for Alexion’s breach of its CRE Obligation.59 It also seeks damages under another breach of contract theory: SRS contends Alexion breached its obligation under Section 3.8(f) of the Merger Agreement not to take any action the primary purpose of which is to avoid the achievement of any milestone (the “Non-Avoidance Obligation“).60 I begin with SRS’s first theory.
A. Alexion Owes Expectation Damages For Breach Of Its CRE Obligation.
SRS proved Alexion breached its CRE Obligation, as the September Opinion explained. “Under Delaware law, the standard remedy for breach of contract is based on the reasonable expectations of the parties that existed before or at the time of the breach.”61 “This principle of expectation damages is measured by the amount of money that would put the promisee in the same position as if the promisor had performed the contract.”62 To
1. Injury
“If a breach is of a promise conditioned on a fortuitous event and it is uncertain whether the event would have occurred had there been no breach, the injured party may recover damages based on the value of the conditional right at the time of breach.”65 As recently observed in Fortis Advisors LLC v. Johnson & Johnson, earnout provisions coupled to an efforts clause are contingent in nature: they require the buyer to pay additional consideration if the buyer or target achieves specified goals, buttressed by a standard to which the buyer must perform.66 This design allocates risk between the buyer and seller. The buyer reduces its risk of overpaying for a business with uncertain prospects, and the seller takes on the risk that the earnout
In Fortis, the buyer’s breach of its efforts obligation to pursue earnout milestones made it impossible to achieve certain milestones.68 Fortis identified a cognizable, and compensable, injury in the decreased expected value of the right to earnout payments, reasoning damages based on that injury would “put the promisee in the same position as if the promisor had performed the contract.”69 Fortis calculated expected value at the time of breach by weighting each milestone by the proven likelihood it would be achieved.70
That logic holds here. SRS’s injury is best understood as the lost expected value of each milestone as compared before and after Alexion’s breach of its CRE Obligation.71 As in Fortis, an expected value approach reflects the theory behind expectation damages, which aim to put “the nonbreaching party in as good a position as he would have been in had the contract been performed, and no better.”72 Compensating for lost expected value, rather than with full value whenever earnout payments are likely and zero value whenever earnout payments are unlikely, strives to hit the mark on the parties’ reasonable expectations, rather than award windfalls for some promisees and goose eggs for others.73
Here, each milestone had an expected value of zero after Alexion’s breach. The
The trial record offers four views of the Milestone Probabilities. First, ATP’s analysis provides estimates around the time of the Syntimmune merger.75 Next, Alexion’s PTRS estimates establish Alexion’s view of the probabilities both before and after receiving the HV-108 data.76 Finally, Kinch’s opinions based on his CDEK data, paired with Russell’s opinions, provide estimates at the time of breach.77
ATP, PTRS, and CDEK all show each milestone had a nonzero probability of being achieved. The probabilities based on PTRS and CDEK require some adjustments.78 Those adjustments are based on probabilistic reasoning and must be explained through mathematical notation. A brief primer follows.
a. Mathematical Primer
The definitions and principles utilized in this opinion apply to arbitrary events, A and B. The probability of any event E is denoted P(E). This opinion follows the █
standard convention of explaining mathematics using the first-person plural.79
i. Conceptual Framework
An introductory text on probability provides a framework.80
The mathematical framework for probability is built around sets. Imagine that an experiment is performed, resulting in one out of a set of possible outcomes. Before the experiment is performed, it is unknown which outcome will be the result; after, the result “crystallizes” into the actual outcome. . . .
The sample space S of an experiment is the set of all possible outcomes of the experiment. An event A is a subset of the sample space S, and we say that A occurred if the actual outcome is in A. . . .
[T]he complement Ac is the event that occurs if and only if A does not occur
.81
The probability of an event either occurring or not occurring is equal to one. So the probability that A does not occur is equal to one minus the probability that it does occur:
P(Ac) = 1 - P(A).82
If another event B is also a subset of the sample space S, then “the intersection A ∩ B is the event that occurs if and only if both A and B occur.”83
“[T]he union A ∪ B is the event that occurs if and only if at least one of A [or] B occurs.”84
P(A ∪ B) = P(A) + P(B) - P(A ∩ B).86
Lastly, in some cases, B is a subset of A. We denote this B ⊆ A.
The area of B relative to the area of S represents P(B). The area of A ∩ B represents P(A ∩ B). But because B and A ∩ B are the same region, their areas are the same. So, if B ⊆ A, then P(A ∩ B) = P(B).87
ii. Conditional Probability
The milestones also introduce the concept of conditional probability. The conditional probability of B given A is denoted by P(B|A). If A and B are events with P(A) > 0, then the conditional probability of B given A is defined as
P(B|A) = P(A∩B)/P(A).88
The definition is
Zooming in on the outcomes covered by A:
B occurs only in the doubly shaded region A ∩ B. The area of that doubly shaded region as a proportion of the area of A represents the probability that B occurs given that A occurs. That is captured in the definition of conditional probability:
P(B|A) = P(A∩B)/P(A), where P(A) > 0.89
This expression may be rewritten by multiplying both sides by P(A). Doing so yields the following rule: for any events A and B with P(A) > 0, P(A ∩ B) = P(A) ⋅ P(B|A).90
iii. Definition Of Independent Events
This opinion also utilizes the definition of independent events. A and B are independent if learning that A “occurred gives us no information that would change the likelihood of B occurring (and vice versa).”91 Events A and B are said to be independent where P(A ∩ B) = P(A) ⋅ P(B).92
iv. The Law Of Total Probability
The final concept needed here is the “law of total probability.” The law of total probability “relates conditional probability to unconditional probability,”93 allowing us
Let A1, . . . , An be a partition of the sample space S, as shown.
Then overlay event B.
The shaded region B is equal to (A1 ∩ B) + (A2 ∩ B) + ⋅⋅⋅ + (An ∩ B). This illustrates that P(B) = P(A1 ∩ B) + P(A2 ∩ B) + ⋅⋅⋅ + P(An ∩ B). We know that P(Ai ∩ B) = P(Ai) ⋅ P(B|Ai), where Ai denotes a given component of the partition A1, . . . , An.95 Thus, we may rewrite P(B) as
P(B) = P(A1) ⋅ P(B|A1) + P(A2) ⋅ P(B|A2) + ⋅⋅⋅ + P(An) ⋅ P(B|An).
The following chart summarizes the relevant expressions above.
| Relevant Expressions | |
|---|---|
| Total of one | P(Ac) = 1 - P(A). |
| Either A or B | P(A ∪ B) = P(A) + P(B) - P(A ∩ B). |
| B as subset of A | If B ⊆ A, then P(A ∩ B) = P(B). |
| Definition of conditional probability | If A and B are events with P(A) > 0, P(B|A) = P(A∩B)/P(A). |
| Both A and B (regardless of independence) | For any events A and B with P(A) > 0, P(A ∩ B) = P(A) ⋅ P(B|A). |
| Definition of independent | A and B are independent if and only if P(A ∩ B) = P(A) ⋅ P(B). |
| Law of total probability | Let A1, . . . , An be a partition of the sample space S. Then, for any event B, P(B) = P(A1) ⋅ P(B|A1) + P(A2) ⋅ P(B|A2) + ⋅⋅⋅ + P(An) ⋅ P(B|An). |
b. Milestone Probabilities Using Pre-HV-108 PTRS Data
Alexion‘s PTRS estimates do not themselves offer Milestone Probabilities. To determine whether Alexion‘s pre-HV-108 estimates of ALXN1830‘s success
demonstrate an expected value for each milestone, that raw data must be translated first into the milestone concepts, then into Milestone Probabilities.
I take these calculations in stages: first M2 through M5, then M6 and M7, and finally M8.
i. P(M2) Through P(M5)
The PTRS data supplies the probability of a successful Phase 2 trial. Milestones 2 and 3 call for dosing in a PCT. A Phase 3 trial qualifies as a PCT.96 The parties characterize a successful Phase 2 trial as one that leads to dosing in a Phase 3 trial.97 So for a given indication, the probability of a successful Phase 2 trial is equivalent to the probability that a patient will be dosed in a PCT, mapping onto M2 and M3. The overall PTRS supplies the probability of FDA approval.98 This maps onto M4 and M5.99
Based on these observations, Alexion‘s PTRS before receipt of the HV-108 data yields the following probabilities for TED and cAMR100:
| | ||
|---|---|---|
| TED | cAMR | |
| Probability of a successful Phase 2 Trial (Probability of a first dosing in a PCT) | 0.43 | 0.50 |
| Overall PTRS (Probability of FDA approval) | 0.30 | 0.34 |
These data account for the dependencies among different stages of clinical development and regulatory approval.101
Calculating P(M2) through P(M5) requires breaking the Milestone Events down into probability inquiries. Let PCTTED and FDATED be the events that TED reaches a PCT and receives FDA approval, respectively. Let PCTcAMR and FDAcAMR be the events that cAMR reaches a PCT and receives FDA approval, respectively.
| Probability Inquiries for M2 through M5 | ||
|---|---|---|
| Event | Inquiry | Notation |
| M2 | What is the probability that either TED or cAMR achieves a first dosing in a PCT? | P(PCTTED ∪ PCTcAMR) |
| M3 | What is the probability that both TED and cAMR achieve a first dosing in a PCT? | P(PCTTED ∩ PCTcAMR) |
| M4 | What is the probability that either TED or cAMR obtains FDA approval? | P(FDATED ∪ FDAcAMR) |
| M5 | What is the probability that both TED and cAMR obtain FDA approval? | P(FDATED ∩ FDAcAMR) |
I treat the TED and cAMR programs as entirely independent, meaning the success of one indication does not affect the probability of success in the other
indication. Kinch‘s testimony supports this approach. He indicated that while proof of concept in one indication could increase another indication‘s probability of success, a “more conservative approach” of treating the indications as independent was warranted.102 I agree the conservative approach is appropriate. I proceed under the assumption that PCTTED and PCTcAMR are independent events and that FDATED and FDAcAMR are independent events.
The table below summarizes the calculations for P(M2) through P(M5).
| Pre-HV-108 PTRS Milestone Probability Calculations for M2 Through M5 | ||
|---|---|---|
| Probability | Inquiry | Calculation |
| P(M2) | P(PCTTED ∪ PCTcAMR) | 0.43 + 0.5 - (0.43 × 0.5) = 0.715. |
| P(M3) | P(PCTTED ∩ PCTcAMR) | 0.43 × 0.5 = 0.215. |
| P(M4) | P(FDATED ∪ FDAcAMR) | 0.3 + 0.34 - (0.3 × 0.34) = 0.538. |
| P(M5) | P(FDATED ∩ FDAcAMR) | 0.3 × 0.34 = 0.102. |
ii. P(M6) and P(M7)
Milestones 6 and 7 depend on both EMA approval and country-specific approvals.103 The probabilities of FDA and EMA approval are assumed to be equal because of the near-universal overlap in approval between the two regulatory entities.104 Under that assumption, if one of the entities grants approval, the probability that the other entity will grant approval is 1. Therefore, an indication‘s
overall PTRS can be thought of not only as its probability of obtaining FDA approval, but also as its probability of obtaining EMA approval.
As for the country-specific approvals, Russell testified these approvals were likely once an indication received EMA approval.105 SRS equated “likely” with a 50.1% chance; I do the same.106 Thus, for a given indication, the probability of achieving both EMA approval and the requisite country-specific approvals may be calculated by multiplying overall PTRS by 0.501. Applied to Alexion‘s pre-HV-108 overall PTRS figures for TED (probability of 0.3) and cAMR (probability of 0.34), this yields the following107:
| Pre-HV-108 Deduced Probabilities (for Milestones 6 and 7) | ||
|---|---|---|
| TED | cAMR | |
| Probability of EMA and country-specific approvals | 0.1503 | 0.17034 |
As before, applying these indication-specific probabilities to the milestones requires breaking the Milestone Events down into probability inquiries. Let EATED be the event that TED receives the requisite European approvals. Let EAcAMR be the event that cAMR receives the requisite European approvals.
| Probability Inquiries for M6 and M7 | ||
|---|---|---|
| Event | Inquiry | Notation |
| M6 | What is the probability that either TED or cAMR obtains the requisite European approvals? | P(EATED ∪ EAcAMR) |
| M7 | What is the probability that both TED and cAMR obtain the requisite European approvals? | P(EATED ∩ EAcAMR) |
The table below summarizes the calculations for P(M6) and P(M7).
| Pre-HV-108 PTRS Milestone Probability Calculations for M6 And M7 | ||
|---|---|---|
| Probability | Inquiry | Calculation |
| P(M6) | P(EATED ∪ EAcAMR) | 0.1503 + 0.17034 - 0.1503 × 0.17034 = 0.295. |
| P(M7) | P(EATED ∩ EAcAMR) | 0.1503 × 0.17034 = 0.0256. |
iii. P(M8)
Milestone 8, based on $1 billion in net sales in a year across all indications, requires
billion in net sales on its own.109 Alexion could have achieved Milestone 8 only if it obtained regulatory approval for both TED and cAMR.
Russell testified that ALXN1830 had the potential to achieve the milestone based on Alexion‘s internal revenue projections for TED and cAMR.110 Alexion‘s 2021 model indicates it expected the indications’ combined revenues to surpass $1 billion in five years, including a $1.35 billion peak.111 Put differently, Alexion‘s peak projection exceeds the $1 billion threshold by 35%. By that margin, the preponderance of the evidence shows it is likely ALXN1830 would have crossed that threshold as long as both TED and cAMR received FDA and EMA approval (even if the indications did not receive all three of the country-specific approvals needed to satisfy Milestones 6 and 7).
Because EMA approval is assumed to be guaranteed upon FDA approval, the probability that both indications would have obtained FDA and EMA approval is equal to the probability that both indications would have obtained FDA approval—i.e., the probability of M5. From there, M8 is likely. So, M8‘s probability is calculated by multiplying M5‘s probability of 0.102 by 0.501.
The pre-HV-108 PTRS probability for M8 is 0.0511.112
c. The Post-HV-108 PTRS Data
The record offers another set of PTRS numbers: those Alexion adjusted after receiving the HV-108 data, just before terminating the ALXN1830 program. Alexion reduced TED‘s chances of a successful Phase 2 trial from 43% to 20%, and it reduced TED‘s overall PTRS from 30% to 10%.113 Alexion also reduced cAMR‘s overall PTRS from 34% to 10%.114 Before the reduction, cAMR‘s probability of a successful Phase 2 trial was 50%.115 But the record does not indicate how much that probability was reduced in response to the HV-108 data.
The post-HV-108 PTRS data paints the following incomplete picture:
| Post-HV-108 Raw Data | ||
|---|---|---|
| TED | cAMR | |
| Probability of a successful Phase 2 Trial | 0.2 | ? |
| Overall PTRS | 0.1 | 0.1 |
| Post-HV-108 Deduced Probabilities | ||
|---|---|---|
| TED | cAMR | |
| Probability of a first dosing in a PCT | 0.2 | ? |
| Probability of FDA approval | 0.1 | 0.1 |
| Probability of EMA and country-specific approvals | 0.0501116 | 0.0501117 |
Without the missing cAMR information, P(M2) and P(M3) cannot be precisely calculated. But because cAMR has a nonzero probability of FDA approval, it must also have a nonzero probability of clinical success, including achieving dosing in a PCT. P(M2) and P(M3) would still be greater than zero even under the decreased post-HV-108 PTRS estimates.
P(M4) through P(M7) can be found using the same calculations performed on the pre-HV-108 data.
| Post-HV-108 PTRS Milestone Probability Calculations for M4 Through M7 | ||
|---|---|---|
| Probability | Inquiry | Calculation |
| P(M4) | P(FDATED ∪ FDAcAMR) | 0.1 + 0.1 - (0.1 × 0.1) = 0.19. |
| P(M5) | P(FDATED ∩ FDAcAMR) | 0.1 × 0.1 = 0.01. |
| P(M6) | P(EATED ∪ EAcAMR) | 0.0501 + 0.0501 - 0.0501 × 0.0501 = 0.098. |
| P(M7) | P(EATED ∩ EAcAMR) | 0.0501 × 0.501 = 0.00251. |
Finally, as in the pre-HV-108 PTRS, P(M8) is calculated by multiplying P(M5) by 0.501. So the post-HV-108 PTRS probability for M8 is about 0.00501.118
d. Milestone Probabilities Using CDEK Data
Kinch‘s opinions based on his CDEK database provide an alternative starting point for estimating the Milestone Probabilities. Kinch‘s Milestone Probability calculations do not properly account for the fact that some milestones are contingent upon others.119 They must be adjusted to
| Kinch‘s Opinions Based on CDEK | |
|---|---|
| Opinion | Notation |
| The probability of M2 is between 0.582 and 1. | 0.582 ≤ P(M2) ≤ 1. |
| The probability of M4 given that M2 occurred is 0.684. | P(M4|M2) = 0.684. |
| The probability of M3 given that M2 occurred is equal to the probability of M2. | P(M3|M2) = P(M2). |
| The probability of M5 given that M4 occurred is equal to the probability of M4. | P(M5|M4) = P(M4). |
i. P(M2)
Kinch estimated a probability range for M2 based on his analysis of CDEK. This figure needs no adjustment. The CDEK probability range for M2 is
0.582 ≤ P(M2) ≤ 1.
ii. P(M3)
ALXN1830 cannot reach a PCT for a second indication unless it has done so for some first indication. So M3 ⊆ M2. It follows that P(M2 ∩ M3) = P(M3).120
From our mathematical primer, we know P(M2 ∩ M3) = P(M2) ⋅ P(M3|M2).121 Therefore,
P(M3) = P(M2) ⋅ P(M3|M2).
Recall Kinch opined that P(M3|M2) = P(M2). That substitution yields
P(M3) = P(M2)2.
Plugging in the lower and upper bounds for P(M2) yields
0.339 ≤ P(M3) ≤ 1.122
iii. P(M4)
First, because it is impossible for any indication to receive FDA approval unless some indication advances to a PCT, M4 ⊆ M2. So P(M2 ∩ M4) = P(M4).123 And we know P(M2 ∩ M4) = P(M2) ⋅ P(M4|M2).124 Therefore,
P(M4) = P(M2) ⋅ P(M4|M2).
Applying Kinch‘s opinion that P(M4|M2) = 0.684 yields
P(M4) = P(M2) ⋅ 0.684.
Plugging in the lower and upper bounds for P(M2) yields
0.398 ≤ P(M4) ≤ 0.684.125
iv. P(M5)
Similarly, because ALXN1830 cannot receive FDA approval for a second indication unless it has done so in some first indication, M5 ⊆ M4. So P(M4 ∩ M5) = P(M5).126 Like before, we know P(M4 ∩ M5) = P(M4) ⋅ P(M5|M4).127 Therefore,
Applying Kinch‘s opinion that P(M5|M4) = P(M4) yields
P(M5) = P(M4)2.
Plugging in the above lower and upper bounds of P(M4) to calculate the lower and upper bounds of P(M5) yields
0.158 ≤ P(M5) ≤ 0.468.128
v. P(M6)
Kinch‘s analysis of milestone probabilities was agnostic as to the number of indications Alexion was pursuing. The CDEK data did not provide information on the number of indications being pursued for a given molecule.129 For purposes of calculating P(M6) based on CDEK, I assume Alexion was pursuing exactly two indications. It is not possible to calculate P(M6) with the available information.130 And Alexion was in fact pursuing two indications at the time of breach. And finally, assuming Alexion was pursuing more than two indications would increase each remaining Milestone Probability, so my calculations serve as a conservative floor for P(M6).
Given the assumption that Alexion was pursuing two indications, P(M6) depends on whether ALXN1830 received FDA approval in zero, one, or two indications. Let us define three events:
FDA0: zero indications receive FDA approval;
FDA1: one indication receives FDA approval;
FDA2: two indications receive FDA approval.
Because these events partition the sample space S, the law of total probability provides that
P(M6) = P(FDA0) ⋅ P(M6|FDA0) + P(FDA1) ⋅ P(M6|FDA1) + P(FDA2) ⋅ P(M6|FDA2).
We may use this expression, Kinch‘s initial opinions, and previous calculations to calculate lower and upper bounds for P(M6).
As to the lower bound, the following table solves for each term on the right-hand side of the expression for P(M6) assuming P(M2) = 0.582. The terms are listed in an order that facilitates calculation.
| | |
|---|---|
| Probability | Explanation |
| P(FDA0) = 0.602. |
P(FDA0) = 1 - P(M4), because M4 occurs when at least one indication receives FDA approval. P(FDA0) = 1 - P(M4) = 1 - 0.398 = 0.602. |
| P(FDA2) = 0.158. |
P(FDA2) = P(M5) because M5 occurs when two indications receive FDA approval. P(FDA2) = P(M5) = 0.158. |
| P(FDA1) = 0.240. |
FDA1 occurs if neither FDA0 nor FDA2 occur. So P(FDA1) = 1 - [P(FDA0) + P(FDA2)]. P(FDA1) = 1 - 0.602 - 0.158 = 0.240. |
| P(M6|FDA0) = 0. | M6 is not possible if zero indications receive FDA approval. |
| P(M6|FDA1) = 0.501. | Because it is assumed that FDA approval guarantees EMA approval, Russell‘s testimony indicates that any indication that receives FDA approval has a 50.1% chance of receiving the requisite European approvals.131 So, if exactly one indication receives FDA approval, M6 occurs with probability 0.501. So, P(M6|FDA1) = 0.501. |
| P(M6|FDA2) = 0.751. | If an indication receives FDA approval, its probability of not receiving the requisite country-specific approvals to satisfy M6 is (1 - 0.501). So, if two indications receive FDA approval, the probability that neither receives the requisite country-specific approvals is (1 - 0.501)2. Thus, the probability that at least one of the indications receives the requisite country-specific approvals is (1 - (1 - 0.501)2).
P(M6|FDA2) = 1 - (1 - 0.501)2 = 0.751. |
Substituting these values into the expression,
P(M6) = (0.602) * (0) + (0.240) * (0.501) + (0.158) * (0.751) = 0.239.
This calculation may also be visualized with a flow chart.
| Upper Bound of Each Term in the Expression for P(M6) | |
|---|---|
| Probability | Explanation |
| P(FDA0) = 0.316. | P(FDA0) = 1 - P(M4) = 1 - 0.684 = 0.316. |
| P(FDA2) = 0.468. | P(FDA2) = P(M5) = 0.468. |
| P(FDA1) = 0.216. | P(FDA1) = 1 - 0.316 - 0.468 = 0.216. |
| P(M6|FDA0) = 0. | The explanation is the same as above. |
| P(M6|FDA1) = 0.501. | The explanation is the same as above. |
| P(M6|FDA2) = 0.751. | The explanation is the same as above. |
Substituting these values into the expression for P(M6),
P(M6) = (0.316) * (0) + (0.216) * (0.501) + (0.468) * (0.751) = 0.460.
Therefore,
0.239 ≤ P(M6) ≤ 0.460.
vi. P(M7)
The record shows that the requisite European approvals follow only after FDA approval. So M7 ⊆ M5. Thus, P(M5 ∩ M7) = P(M7). Additionally, we know P(M5 ∩ M7) = P(M5) * P(M7|M5). Therefore,
P(M7) = P(M5) * P(M7|M5).
Based on Russell‘s testimony, (M7|M5) = (0.501)2.132
P(M7) = P(M5) * (0.501)2.
Plugging in the lower and upper bounds for P(M5) yields:
0.0398 ≤ P(M7) ≤ 0.117.133
vii. P(M8)
Milestone 8‘s CDEK probability can be calculated in the same manner used for the PTRS calculations.134
P(M8) = P(M5) * (0.501).
Using the lower and upper bounds calculated for P(M5),
0.0794 ≤ P(M8) ≤ 0.234.135
In sum, the CDEK probabilities are as follows:
| CDEK Probabilities | |
|---|---|
| Milestone Event | Probability |
| M2 | 0.582-1 |
| M3 | 0.339-1 |
| M4 | 0.398-0.684 |
| M5 | 0.158-0.468 |
| M6 | 0.239-0.460 |
| M7 | 0.0398-0.117 |
| M8 | 0.0794-0.234 |
e. Comparison Of Milestone Probability Estimates
I have summarized the probability estimates under the three complete views from the record evidence, plus the incomplete view based on the post-HV-108 PTRS data.
| | ||||
|---|---|---|---|---|
| Event | ATP | Pre-HV-108 PTRS | Post-HV-108 PTRS | CDEK |
| M2 | 0.80 | 0.715 | > 0 | 0.582-1 |
| M3 | 0.75 | 0.215 | > 0 | 0.339-1 |
| M4 | 0.53 | 0.538 | 0.190 | 0.398-0.684 |
| M5 | 0.45 | 0.102 | 0.0100 | 0.158-0.468 |
| M6 | 0.53 | 0.295 | 0.0977 | 0.239-0.460 |
| M7 | 0.45 | 0.0256 | 0.00251 | 0.0398-0.117 |
| M8 | 0.10 | 0.0511 | 0.00501 | 0.0794-0.234 |
No dataset indicates the probability of achieving any given milestone was zero. SRS has proven by a preponderance of the evidence that the probability of achieving each milestone-and therefore the expected value of each milestone-was greater than zero at the time of breach. SRS has proven an injury from Alexion‘s breach, in general and as tethered to each milestone.
2. Causation
Expectation damages are certainly available when the plaintiff proves the defendant‘s breach was the but-for cause of its injury.136 Here, Alexion‘s breach was the termination of the ALXN1830 program, which eliminated all expected value in the milestones at the time of breach. That termination was the but-for cause of SRS‘s loss of expected value: there was no time or opportunity for any intervening cause to contribute to that loss.
Alexion argues SRS must prove ALXN1830 was more likely than not to achieve a given milestone to establish proximate cause.137 But Alexion misunderstands SRS‘s injuries as lost milestone payments in toto. As explained, the injury is the loss of expected value associated with milestone payments triggered by progress Alexion makes using CREs. SRS must still show causation: it must prove Alexion‘s failure to use CREs caused a loss in expected value with reasonable certainty.138 It has done so.
3. Estimate Of Damages
“The amount of damages can be an estimate,”139 provided “the court has a basis to make a responsible estimate of damages.”140 Delaware law grants the Court flexibility to use its “conscience and reason” to determine such an estimate and to determine whether setting an estimate is appropriate under the circumstances.141
Doubts [about the extent of damages] are generally resolved against the party in breach. A party who has, by his breach, forced the injured party to seek compensation in damages should not be allowed to profit from his breach where it is established that a significant loss has occurred. A court may take into account all the circumstances of the breach, including willfulness, in deciding whether to require a lesser degree of certainty, giving greater discretion to the trier of the facts. Damages need not be calculable with mathematical accuracy and are often at best approximate.142
In Fortis, “the parties’ contemporaneous risk-adjusted probabilities of success” were the best evidence of the milestones’ expected payouts “absent [the promisor‘s] breaches.”143 Fortis was able to rely on the parties’ own projections for several reasons. First, little time had passed between the date of those projections and the time of the promisor‘s breaches.144 Second, because the promisor “had deep knowledge of its own ability to reach the milestones,” and the promisee‘s “independent estimate came after (or during) multiple rounds of due diligence and was remarkably close to [the promisee‘s] predictions,” the probabilities provided “a credible, responsible basis to calculate” damages.145 And third, the plaintiff‘s more optimistic view of the probabilities was balanced out by the defendant‘s more conservative view.146
Similarly, here, the strongest evidence of the Milestone Probabilities is derived from Alexion‘s own pre-HV-108 PTRS estimates made shortly before the breach. ATP‘s November 2018 estimates are not a good indication of SRS‘s expectation damages at the time of breach because those estimates were not contemporaneous with the breach, and reflect very different circumstances. Most notably, in 2018, Alexion was pursuing treatments for PV, gMG, and WAIHA; by the fall of 2021, Alexion‘s was solely focused on TED and cAMR.147
The CDEK estimates (based on Kinch‘s and Russell‘s testimony) are anchored to the time of breach. But I am skeptical of the reliability of Kinch‘s CDEK database on which those estimates are based. First, because the database only includes publicly available data, it systematically overestimates probabilities of success; Kinch acknowledged that failures are underreported.148 Unlike the private databases CDEK intends to mimic, CDEK is not a
Further, this opinion has explained the deficiencies in Kinch‘s probability calculations. While I recalculated the CDEK probabilities based on Kinch‘s initial opinions from his database, Kinch‘s mathematical errors undermine his overall credibility.
As for the pre-HV-108 PTRS estimates, those are Alexion‘s own internal predictors of clinical and regulatory success, set by those with detailed knowledge of the ALXN1830 program just before the breach, and untainted by a desire to terminate the program. Alexion‘s management team was capable of estimating its own molecule‘s probability of success accurately enough to serve as a starting point for a responsible estimate of damages.
To be sure, the pre-HV-108 PTRS figures do not appear as reliable as those in Fortis. The September Opinion expressed skepticism of PTRS as subjective and easy to manipulate.151 It remains unclear how PTRS is calculated and what objective data it uses.152 The September Opinion afforded Alexion‘s reduced post-HV-108 PTRS little weight as an explanation for Alexion‘s decision to terminate ALXN1830, instead concluding Alexion shut down the program to deliver on AstraZeneca‘s promise of merger synergies.153 But the record offers no reason to doubt Alexion‘s pre-HV-108 PTRS numbers, despite its subjective inputs. The pre-HV-108 numbers are a conservative starting point and a responsible one.
a. Calculation Of Expected Milestone Payments
With the pre-HV-108 PTRS probabilities as the starting point for the estimate of damages, I have calculated each milestone‘s expected payment by weighting the milestone amount by its probability of achievement.154
| Expected Milestone Payments | |||
|---|---|---|---|
| Milestone | Milestone Amount | Probability | Expected Payment |
| 2 | $ 120,000,000.00 | 0.715 | $ 85,800,000.00 |
| 3 | $ 120,000,000.00 | 0.215 | $ 25,800,000.00 |
| 4 | $ 150,000,000.00 | 0.538 | $ 80,700,000.00 |
| 5 | $ 150,000,000.00 | 0.102 | $ 15,300,000.00 |
| 6 | $ 25,000,000.00 | 0.295 | $ 7,375,947.45 |
| 7 | $ 25,000,000.00 | 0.0256 | $ 640,052.55 |
| 8 | $ 80,000,000.00 | 0.0511 | $ 4,088,160.00 |
| Total | $ 219,704,160.00 | ||
b. Present Value of Expected Milestone Payments
From there, the expected milestone payments must be discounted to present value at the time of breach to put SRS in the economic position it would have been in absent a breach.155 The present value of a future lump sum (“PV“) is a function of the estimated future value of the lump sum (“FV“), a discount rate reflecting risk (“r“), and the number of periods between the date the lump sum is received and the present date (“n“).156 The formula for present value can be expressed as PV = FV / (1 + r)n.
For each milestone, FV is the milestone‘s expected payment shown in the last section. I address the variables n and r in turn.
i. Estimating n
The variable n in the present value formula varies based on each milestone‘s expected payment date at the time of breach. For Milestones 2 through 5, the best evidence of the expected payment dates is a slide deck prepared for the December 14, 2021, meeting in which Alexion decided to terminate ALXN1830.157 The deck contains draft developmental timelines for TED and cAMR, which evince the following expected milestone schedule158:
| Expected Achievement Schedule for Milestones 2 Through 5 | |
|---|---|
| Milestone | Month/Quarter of Achievement |
| 2 | June 2025 |
| 3 | August 2025 |
| 4 | Q2 2028 |
| 5 | Q2 2029 |
The draft timelines do not indicate how long after FDA approval EMA approval would be obtained. In 2018, Alexion predicted EMA approval would occur two years after FDA approval for a given indication.159 ATP‘s 2018 valuation assumes FDA approval and EMA approval would occur at approximately the same time.160 Applying Alexion‘s more conservative timing estimate for EMA approval, I conclude Milestone 6 was expected to be achieved in Q2 2030, and Milestone 7 was expected to be achieved in Q2 2031.
As for Milestone 8, ATP‘s valuation conservatively assumes that if the milestone were achieved, it would be achieved during the year with the highest projected sales.161 ATP‘s conservative approach is appropriate for a responsible estimate of damages. At the time of breach, Alexion projected 2036 as its peak sales year.162 Because Alexion‘s fiscal year coincides with the calendar year, I conclude Milestone 8‘s expected achievement date was December 31, 2036.163
| Milestone Expected Achievement Dates and Payment Due Dates | ||
|---|---|---|
| Milestone | Expected Achievement Date | Expected Payment Due Date |
| 2 | June 15, 2025 | July 30, 2025 |
| 3 | August 15, 2025 | September 29, 2025 |
| 4 | May 17, 2028 | July 1, 2028 |
| 5 | May 17, 2029 | July 1, 2029 |
| 6 | May 17, 2030 | July 1, 2030 |
| 7 | May 17, 2031 | July 1, 2031 |
| 8 | December 31, 2036 | February 14, 2037 |
ii. Estimating r
“A discount rate reflects both the time value of money and risk.”166 It represents the total expected rate of return an investor demands.167 SRS proposes using Alexion‘s 9% weighted average cost of capital (“WACC“) from 2018 as the discount rate.168 But SRS‘s valuation expert was excluded,169 SRS does not explain why it believes Alexion‘s WACC is the appropriate discount rate, and I do not think it is appropriate except as applied to Milestone 8.
A company‘s cost of capital is the expected rate of return the company needs to attract investors.170 It can be thought of as an opportunity cost.171 Riskier investments have a higher cost of capital because capital is a limited resource: when investors commit funds to riskier projects, they are foregoing safer alternatives. So investors demand a risk premium over the risk-free rate: higher expected returns to compensate for taking on additional risk.172
In lost profits cases, the cost of capital may be the proper discount rate.173 “[B]ecause the plaintiff no longer has to bear the investment‘s risk, the plaintiff is not entitled to be compensated for the risk
Here, for Milestones 2 through 7, there is no risk premium on the right to receive milestone payments. To be sure, the probability-weighted expected payments are not “already risk adjusted” just because they “factor[] in the possibility of good and bad outcomes.”177 Expected value is a risk-neutral metric.178 But the risks underlying the metrics in Milestones 2 through 7 are “diversifiable.”179 A diversifiable risk is one “that is peculiar to an individual company.”180 Such risks can be “diversified away” through a broad investment portfolio “due to the law of large numbers.”181 In the context of contingent consideration, diversifiable risks include product development milestones (like Milestones 2 and 3) and regulatory approval milestones (like Milestones 4 through 7).182 Because the risk associated with Milestones 2 through 7 can be diversified away, that risk commands no risk premium, and there is no need to discount for a risk premium in awarding damages. Alexion‘s cost of capital is not an appropriate discount rate.
For Milestones 2 through 7, the discount rate is the risk-free rate plus a credit risk premium.183 For a given milestone, that sum is Alexion‘s cost of debt “specific to the term and seniority of the earnout obligation.”184 ATP estimated this amount based on the yield for investment-grade corporate bonds with maturities equal to the expected time to reach a given milestone.185 So ATP used the bond yield as the discount rate.186
Milestone 8 is different because the risk associated with its underlying metric is “nondiversifiable.” As the name suggests, nondiversifiable (or “systemic“) risk, “cannot be fully removed through diversification” because it is “correlated with the market.”191 Metrics with nondiversifiable risk include financial metrics such as EBITDA or net sales.192 If an earnout metric carries systemic risk, the discount rate must include a risk premium “commensurate with the degree” of systemic risk.193
Milestone 8‘s net sales metric carries nondiversifiable risk.194 So the milestone‘s discount rate must therefore include a risk premium. SRS‘s suggested 9% discount rate includes a risk premium. Without expert guidance, the appropriateness of the 9% figure is uncertain. Alexion‘s WACC may have changed since 2018. And it is unclear whether Alexion‘s WACC is the best metric to measure the discount rate in this context. But “[d]oubts [about the amount of damages] are generally resolved against the party in breach.”195 As the wrongdoer, Alexion cannot be allowed to profit from its breach via an overly conservative discount rate for Milestone 8, particularly where Alexion offers no input as to the appropriate discount rate.196 Given Delaware‘s recognition of the wrongdoer rule, I believe 9% is an appropriate discount rate for Milestone 8 taking into account “all the circumstances of the breach.”197
iii. Pre-Interest Expectation Damages Calculation
I have calculated the present value of expected earnout payments based on
| Present Value of Expected Milestone Payments | |||
|---|---|---|---|
| Milestone | Milestone Payout | Expected Payment | Present Value |
| 2 | $ 120,000,000.00 | $ 85,800,000.00 | $ 75,522,351.83 |
| 3 | $ 120,000,000.00 | $ 25,800,000.00 | $ 22,576,414.19 |
| 4 | $ 150,000,000.00 | $ 80,700,000.00 | $ 64,092,303.86 |
| 5 | $ 150,000,000.00 | $ 15,300,000.00 | $ 11,731,346.77 |
| 6 | $ 25,000,000.00 | $ 7,375,947.45 | $ 5,460,071.74 |
| 7 | $ 25,000,000.00 | $ 640,052.55 | $ 457,425.38 |
| 8 | $ 80,000,000.00 | $ 4,088,160.00 | $ 1,105,001.54 |
| Total | $ 180,944,915.32 | ||
SRS‘s pre-interest expectation damages for Alexion‘s breach of its CRE Obligation are $180,944,915.32.
B. SRS‘s Damages Claim For Breach Of Merger Agreement Section 3.8(f)‘s Requirement Not To Take Action To Avoid Milestones
Count IV of SRS‘s amended complaint alleges Alexion breached its Non-Avoidance Obligation by taking actions with the primary purpose of avoiding milestones.198 The September Opinion did not address whether Alexion‘s termination of ALXN1830 breached the Non-Avoidance Obligation. The September Opinion asked the parties to advise if SRS‘s Count IV carried with it any additional potential for damages or practical ramifications.199 Despite SRS‘s best efforts in supplemental briefing,200 Count IV does not carry any additional potential for damages.201 SRS is receiving its expectation damages based on Alexion‘s breach of the CRE Obligation. I do not address Count IV.
1. Application Of The Prevention Doctrine Would Not Result In Additional Damages.
SRS contends a breach of Alexion‘s Non-Avoidance Obligation would trigger Delaware‘s prevention doctrine. SRS asserts that under that doctrine, unless Alexion can prove its breach did not materially contribute to the nonoccurrence of a given milestone, SRS is entitled to full payment on each milestone. For purposes of this argument, I accept, with some hesitation, SRS‘s assertion that the Non-Avoidance Obligation is a contractual codification of Delaware‘s prevention doctrine.
The prevention doctrine “provides that a party may not escape contractual liability by reliance upon the failure of a
But the “plaintiff is not entitled to take advantage of this situation” to obtain a windfall.205 “[T]he damages recoverable represent the harm resulting from th[e] lack of cooperation.”206 For instance, “[i]f the defendant‘s conduct in preventing the plaintiff‘s performance has enabled the plaintiff to avoid expenses, the expenses saved must be deducted from the damages otherwise recoverable, for otherwise, the plaintiff would be overcompensated as a result of the defendant‘s breach.”207 This “principle of mitigation” reflects Delaware‘s broader policy against awarding windfalls.208 Consistent with that policy, the prevention doctrine does not provide a plaintiff a back door to damages in excess of proven expectation damages.209
With interest, SRS pegs full milestone payment damages at $754,877,262.02.210 But as explained, SRS‘s expectation damages amount to the present value of the expected value of those milestones. With interest, this opinion calculates those damages at around $220 million. SRS‘s application of the prevention doctrine would result in a half-a-billion-dollar windfall. Delaware law does not permit that. Given this opinion‘s award of expectation damages, the parties’ expectations have been enforced, and Alexion has not been permitted to take advantage of its breach. The prevention doctrine cannot offer SRS more than its expectation damages.
SRS offers no other practical ramifications from Alexion‘s alleged breach of its Non-Avoidance Obligation.211 Count IV is moot.
C. Pre- And Post-Judgment Interest
Alexion does not contest SRS‘s entitlement to pre- and post-judgment interest
D. Attorneys’ Fees And Expenses
SRS‘s post-trial brief argues it is entitled to reasonable attorneys’ fees and expenses under Section 8.2 of the Merger Agreement.213 Section 8.2 provides for indemnification against “Losses . . . arising out of or resulting from . . . any breach of any covenant” in the Merger Agreement.214 “Losses” are defined to include “reasonable attorneys’ fees and expenses.”215
The Merger Agreement requires written notice for any indemnification claim, which must “state in reasonable detail the nature, basis and the amount of the Direct Claim, to the extent known, along with copies of the relevant documents evidencing such Direct Claim and the basis for indemnification sought.”216 SRS makes no argument that it has satisfied the notice requirements.217 SRS is not entitled to attorneys’ fees and expenses under the Merger Agreement‘s indemnification provisions at this point in time.
III. CONCLUSION
SRS is awarded $180,944,915.32 in damages, plus pre- and post-judgment interest, for Alexion‘s breach of its obligation to use CREs. Within 30 days, the parties shall confer on an interest calculation consistent with the methodology adopted in this opinion and submit a proposed stipulated order implementing this opinion and the damages awarded in the September Opinion.
Notes
Citations in the form “SRS Op. Suppl. Br. —” refer to SRS’s post-trial opening supplemental damages brief, available at docket item (“D.I.“) 384. Citations in the form “ALXN Ans. Suppl. Br. —” refer to Alexion’s post-trial answering supplemental damages brief, available at D.I. 392. Citations in the form “SRS Reply Suppl. Br. —” refer to SRS’s post-trial supplemental damages reply brief, available at D.I. 398.
A leading treatise on damages observes, “Only so much judicial time can be used to investigate the precise losses suffered or the gains received from a contract breach.” 3 Dan B. Dobbs, Law of Remedies: Damages—Equity—Restitution § 12.1(2), at 18 (2d ed. 1993) [hereinafter “Dobbs“]. This opinion has probably exceeded whatever that amount of time should be.
ATP calculated that if Milestone 8 were achieved, it would receive $57,886,923. ATP assumed that if the milestone were achieved, it would be achieved in 2026.
ATP’s report states the “average present value across 100,000 different simulation paths” was $4,047,941.
where R is the success rate. See Joseph K. Blitzstein & Jessica Hwang, Introduction to Probability 149–50 (2015). Solving that equation yields a success rate of about 10%, which corresponds to the probability of success for Milestone 8.$4,047,941 = R · $40,431,131.57,
The preponderance of the evidence at trial showed an industry understanding of near-universal overlap in approval by the FDA and EMA, supporting the assumption that FDA and EMA approval go hand in hand. SRS’s antibody development expert assumed EMA approval was guaranteed upon FDA approval, and Alexion assumed the same in its internal projections. Kinch Tr. 353–54, 413; JX 2498 at 73; see JX 690 at 276; JX 2962 at 23. So overall PTRS may be thought of as the probability of FDA approval, the probability of EMA approval, or the probability of FDA and EMA approval.
Neither the record nor the parties suggest that “regulatory success” requires obtaining the “reimbursement and/or pricing approval[s]” for Milestones 6 and 7. Merger Agr. § 3.8(c).
Importantly, this is very different than suggesting M2 was just as likely as M3 from the outset. If M2 and M3 had the same probability, that would mean ALXN1830’s chances of reaching a PCT in at least two indications were the same as its chances of reaching a PCT in at least one indication. In other words, it would imply that a second indication was guaranteed to reach a PCT upon a first indication doing so. That would have been great news for monoclonal antibody research.
Delaware law does not prohibit this approach in this context, contrary to Alexion’s suggestions. Alexion’s pretrial brief cites Sherman v. Ellis for the proposition that “Delaware law does not recognize the ‘Loss of Chance’ theory in breach of contract cases.” D.I. 313 at 58 (citing Sherman v. Ellis, 246 A.3d 1126, 1132 (Del. 2021)). Sherman declined to apply an “increased risk of harm” theory (typically used in medical malpractice cases) in a legal negligence action because causation for that claim “requires proof that, but for the attorney’s negligence, the plaintiff would have obtained a more favorable result.” Sherman, 246 A.3d at 1132–33 (quoting Sherman v. Ellis, 2020 WL 30393, at *13 (Del. Super. Ct. Jan. 2, 2020)). In other words, for a legal negligence claim, the causation standard precludes loss of expected value associated with the pursuit of an unlikely favorable result as a compensable injury. Sherman does not suggest an analogous principle applies in the breach of contract context. See generally
The medical malpractice context uses the related, but different, “increased risk of harm” and “loss of chance” theories. United States v. Anderson, 669 A.2d 73, 75–76 (Del. 1995). Increased risk allows recovery for the increased risk of a future harm before that harm occurs. Loss of chance allows recovery only after the harm occurs.
To calculate M6‘s CDEK probability, I assumed Kinch‘s opinions contemplated two indications. It was not necessary to assume which specific indications were at play. Given that Alexion was in fact pursuing TED and cAMR, I believe it is fair to calculate M8‘s CDEK probability in a manner that mirrors that reality.
My M8 CDEK calculations thus assume M8 was likely to occur if ALXN1830 received FDA approval in the two indications assumed to be at play, but that M8 otherwise would not occur.