CIARCIELLO v. BIOVENTUS INC.

CourtDistrict Court, M.D. North Carolina
DecidedNovember 6, 2023
Docket1:23-cv-00032
StatusUnknown

This text of CIARCIELLO v. BIOVENTUS INC. (CIARCIELLO v. BIOVENTUS INC.) is published on Counsel Stack Legal Research, covering District Court, M.D. North Carolina primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
CIARCIELLO v. BIOVENTUS INC., (M.D.N.C. 2023).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF NORTH CAROLINA

ROBERT CIARCIELLO, Individually ) and on Behalf of All Others Similarly ) Situated, ) ) Plaintiff, ) ) v. ) 1:23-CV-32 ) BIOVENTUS INC., KENNETH M. ) REALI, MARK L. SINGLETON, ) GREGORY O. ANGLUM, and ) SUSAN M. STALNECKER, ) ) Defendants. )

MEMORANDUM OPINION AND ORDER

Catherine C. Eagles, District Judge. The plaintiffs allege that the defendants violated the Securities and Exchange Act of 1934 and the Securities Act of 1933 by making false and misleading statements in various SEC filings and earnings phone calls. The defendants seek to dismiss the plaintiffs’ second amended complaint. The defendants’ motion to dismiss the 1933 Securities Act claims will be granted because the lead plaintiff has not alleged facts to plausibly show statutory standing to assert these claims. The complaint otherwise alleges many factual details sufficient to plausibly allege with particularity misleading statements made with knowledge and causing loss, so the Exchange Act claims may proceed. I. Allegations in the Second Amended Complaint The defendant, Bioventus, Inc., is a medical device and pharmaceutical company that sells drug therapies, including hyaluronic acid injections. Doc. 58 at ¶¶ 39–40. The revenue from these sales is affected by contracts Bioventus has with third party payers, like health insurance companies. Id. at ¶ 41. These contracts require Bioventus to pay rebates to the third-party payers when an insured patient gets a Bioventus injection. Id.

Bioventus provides public certifications of net revenue in SEC filings. See, e.g., id. at ¶¶ 108, 111. From early 2021 to late 2022, Bioventus stated that it deducts expected rebates, calculated based on historical data, buying trends, and other appropriate variables, from its recognized revenue. See, e.g., id. at ¶¶ 78–79, 237. In those filings and other public declarations, the defendants also said that they follow generally accepted

accounting principles and had designed a reasonable internal control system for financial reporting. See, e.g., id. at ¶ 104. After an unexpectedly large payout on a rebate claim in the summer of 2021, Bioventus conducted an internal audit of the processes and controls for estimating and managing rebates. Id. at ¶¶ 83–84. The audit was highly critical of the way Bioventus

was calculating expected rebates and identified at least 12 action items as “red,” meaning that issue was severe and required immediate attention and correction. Id. at ¶¶ 50–51, 85. Defendants Kenneth Reali, Gregory Anglum, and Susan Stalnecker received the report in late August or early September 2021. Id. at ¶ 96. After the audit, Bioventus failed to make needed changes in the rebate estimation

process, leading more than one employee who worked on the audit report to resign in early 2022. Id. at ¶ 100. The defendants continued to discuss their processes and controls positively in SEC filings and otherwise, see, e.g., id. at ¶¶ 102–05, and to report revenue based on the inadequate estimation process. Id. at ¶ 107. The defendant’s revenue is also affected by reimbursement payments made to Bioventus by the Centers for Medicare and Medicaid Services. Id. at ¶ 121. Historically, Bioventus received payment from CMS based on its wholesale acquisition cost, which

did not take into account rebates and discounts; this allowed Bioventus to receive larger reimbursements than if reimbursed based on average sales price. Id. In 2020, Congress passed legislation requiring healthcare manufacturers seeking Medicare reimbursements to report average sales price instead of wholesale acquisition cost starting on January 1, 2022. See id. at ¶ 122. This shift meant Bioventus would

receive significantly less in reimbursements from Medicare. Id. at ¶ 123. The defendants repeatedly assured investors that Bioventus had planned for this change by, among other things, securing agreements with private payers for lower rebates. Id. at ¶ 129. The defendants also said Bioventus had run careful calculations showing that the shift in price reporting would have a “net-neutral” impact. See, e.g., id.

at ¶¶ 129, 132, 134. After the price reporting shift took effect, the defendants repeatedly said that everything went exactly as expected and that the shift was consistent with the modeling. Id. at ¶ 139. But in fact, Bioventus had not carefully calculated the effect of the price shift, as it lacked basic information needed to model the impact of the pricing change.

See id. at ¶ 130. And Bioventus had not obtained agreements from private payers for lower rebates. Id. at ¶ 133. In November 2022, Bioventus filed its third quarter Form 8-K, reporting a lower than previously anticipated revenue. Id. at ¶ 147. Bioventus partially attributed this to a large rebate request from an insurer, which it characterized as “unexpected,” see id. at ¶ 148, even though the defendants were aware of the likelihood of a large rebate request like this one because of the large rebate request and the audit report in 2021. Id. at

¶¶ 149–50. Bioventus also claimed that the legislatively required price reporting shift contributed to the revenue shortfall. Id. at ¶ 148. As a result of the third quarter filing, stock prices significantly declined. See id. at ¶ 153. Other factual allegations will be discussed as needed in connection with specific arguments of the parties.

II. Defendants’ Motion to Dismiss Plaintiffs filed this action, alleging that defendants violated §§ 10(b) and 20(a) of the Securities and Exchange Act of 1934 (Exchange Act) and §§ 11 and 15 of the Securities Act of 1933 (Securities Act).1 Doc. 58. Defendants responded with their motion to dismiss for failure to state a claim. Doc. 63.

a. Does the Second Amended Complaint state claims under § 10(b) and § 11? Defendants challenge the plaintiffs’ second amended complaint on the grounds that the statements were not false or misleading, the plaintiffs did not allege facts showing that the defendants acted with the requisite scienter, and the plaintiffs did not

suffer a loss attributable to the statements. See generally, Doc. 64. These challenges

1 Specifically, plaintiffs allege that all named defendants violated the Exchange Act and all the defendants other than Mark Singleton violated the Securities Act. Doc. 58 at ¶¶ 38, 212– 27, 339–44. Mr. Singleton was not employed at Bioventus at the time of the alleged Securities Act violations. Id. at ¶ 35. raise factual disputes more appropriate for later in the proceedings, ignore the substance of the complaint, and rely on conclusory assertions that are little more than opinions of counsel.

The plaintiffs set forth extensive facts to support the following: (1) Bioventus never designed or implemented a documented or consistent process for estimating rebates and changed the estimated inputs for rebate calculation without any data or legitimate reason, see, e.g., Doc. 58 at ¶ 187(b); (2) the defendants knew that their rebate calculation methods were inadequate because of the large rebate request in 2021 and the audit report,

see, e.g., id. at ¶¶ 95–96; (3) the defendants did not take serious steps to create a process for estimating rebates that went beyond guessing, see, e.g., id. at ¶ 66; and (4) the defendants continued to assert that they had adjusted net revenue projections based on a careful evaluation of data, including “historical experiences” and “known market events and trends” when they had not. See, e.g., id. at ¶¶ 236–37. These facts, summarized

supra but alleged in detail in the operative complaint, allow the inference that the defendants’ representations about revenue and the effect of the Medicare price change were false and misleading and that the defendants acted with the requisite degree of scienter.

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CIARCIELLO v. BIOVENTUS INC., Counsel Stack Legal Research, https://law.counselstack.com/opinion/ciarciello-v-bioventus-inc-ncmd-2023.