Subsequent Events	6 Months Ended
Jun. 30, 2019
SUBSEQUENT EVENTS
Subsequent Events	17. Subsequent Events Stock Purchase Agreement On July 9, 2019, the Company issued and sold a total of 425,880 shares of common stock to the underwriters of the Company’s June 17, 2019 underwritten stock offering. The shares sold to the underwriters were issued upon the partial exercise of the underwriters’ overallotment option. The Company received total offering proceeds from the exercise of the over-allotment option (net of underwriting commissions and offering fees) of approximately $1.2 million. I.V. Triferic NDA Acceptance for Filing On August 2, 2019, the Company received notice from the FDA that the Company’s NDA for I.V. Triferic, which was submitted in May, has been accepted for filing, with a Prescription Drug User Fee Act (“PDUFA”) date of March 28, 2020. Amendment to Product Purchase Agreement On August 1, 2019, the Company executed a Products Purchase Agreement (the “Purchase Agreement”) with DaVita Inc. (“DaVita”), with such agreement effective as of July 1, 2019. The Purchase Agreement supersedes and replaces that certain First Amended and Restated Products Purchase Agreement, effective as of May 8, 2013 (as subsequently amended) by and between the Company and DaVita, which agreement expired effective as of July 31, 2019 (the “Prior Agreement”). Pursuant to the Purchase Agreement, the Company will supply certain DaVita dialysis centers with dialysis acid concentrate (i.e., CitraPure® (Liquid and Dry Acid), Dri-Sate® Dry Acid or RenalPure® Liquid Acid) and bicarbonate (i.e., RenalPure® Bicarbonate Powder or Sterilyte® Liquid Bicarbonate) through December 31, 2023 (the “Initial Term”), subject to certain terms and conditions. The Purchase Agreement provides for an increase in the product sale prices relative to the prices charged for these products under the Prior Agreement. If, upon expiration of the Initial Term, the parties have not completed an extension or a new purchase agreement, the Purchase Agreement will continue in effect until terminated by either party with 90 days written notice or until the completion of an extension or new purchase agreement. Centers for Medicare & Medicaid Services (“CMS”) preliminary proposed rule On July 29, 2019, CMS issued a preliminary proposed rule that proposes to update payment policies and rates under the End-Stage Renal Disease (“ESRD”) Prospective Payment System for renal dialysis services furnished to beneficiaries on or after January 1, 2020 (the “Proposed Rules”). The Proposed Rules contain certain proposed revisions to the eligibility requirements for the CMS Transitional Drug Add-on Payment Adjustment (“TDAPA”) program, which has the potential to provide two years of add-on reimbursement for certain qualifying new drugs. Under the proposed revisions to the TDAPA rules, if finalized, ESRD drugs approved by the FDA under the following types of NDAs would be ineligible for TDAPA, effective as of January 1, 2020: (a) NDA Types 3, 5, 7 and 8, (b) NDA Type 3 in combination with NDA Type 2 or NDA Type 4, (c) NDA Type 5 in combination with NDA Type 2, or (d) NDA Type 9, when the “parent NDA” is NDA Type 3, 5, 7 or 8. As previously disclosed, the Company has filed an NDA for the intravenous formulation of Triferic. The FDA has not informed the Company what the classification will be for the I.V. Triferic NDA, although the two prior Triferic NDAs that have been approved were Types 3 and 5. If the I.V. Triferic NDA is classified as either of those Types, or any of the other excluded NDA Types listed in the Proposed Rules, the Company believes that it could be adversely impacted by the Proposed Rules, because it would not be eligible for reimbursement under the Proposed Rules relating to CMS’ TDAPA program. The Company previously disclosed projections for the overall peak Triferic market opportunity in the United States have been based on an assumed market price for I.V. Triferic that is within the CMS reimbursement bundle payment system and not a sustained, higher price based on TDAPA eligibility. CMS is accepting comments on the Proposed Rules through September 27, 2019. Rockwell plans to vigorously oppose this change in the TDAPA eligibility requirements. The Company is currently assessing the impact the Proposed Rules would have on current inventory valuations and stock compensation arrangements if such proposed rule would be finalized and the type of classification for the I.V. Triferic NDA was included.

17. Subsequent Events

Stock Purchase Agreement

On July 9, 2019, the Company issued and sold a total of 425,880 shares of common stock to the underwriters of the Company’s June 17, 2019 underwritten stock offering. The shares sold to the underwriters were issued upon the partial exercise of the underwriters’ overallotment option. The Company received total offering proceeds from the exercise of the over-allotment option (net of underwriting commissions and offering fees) of approximately $1.2 million.

I.V. Triferic NDA Acceptance for Filing

On August 2, 2019, the Company received notice from the FDA that the Company’s NDA for I.V. Triferic, which was submitted in May, has been accepted for filing, with a Prescription Drug User Fee Act (“PDUFA”) date of March 28, 2020.

Amendment to Product Purchase Agreement

On August 1, 2019, the Company executed a Products Purchase Agreement (the “Purchase Agreement”) with DaVita Inc. (“DaVita”), with such agreement effective as of July 1, 2019. The Purchase Agreement supersedes and replaces that certain First Amended and Restated Products Purchase Agreement, effective as of May 8, 2013 (as subsequently amended) by and between the Company and DaVita, which agreement expired effective as of July 31, 2019 (the “Prior Agreement”).

Pursuant to the Purchase Agreement, the Company will supply certain DaVita dialysis centers with dialysis acid concentrate (i.e., CitraPure® (Liquid and Dry Acid), Dri-Sate® Dry Acid or RenalPure® Liquid Acid) and bicarbonate (i.e., RenalPure® Bicarbonate Powder or Sterilyte® Liquid Bicarbonate) through December 31, 2023 (the “Initial Term”), subject to certain terms and conditions. The Purchase Agreement provides for an increase in the product sale prices relative to the prices charged for these products under the Prior Agreement. If, upon expiration of the Initial Term, the parties have not completed an extension or a new purchase agreement, the Purchase Agreement will continue in effect until terminated by either party with 90 days written notice or until the completion of an extension or new purchase agreement.

Centers for Medicare & Medicaid Services (“CMS”) preliminary proposed rule

On July 29, 2019, CMS issued a preliminary proposed rule that proposes to update payment policies and rates under the End-Stage Renal Disease (“ESRD”) Prospective Payment System for renal dialysis services furnished to beneficiaries on or after January 1, 2020 (the “Proposed Rules”). The Proposed Rules contain certain proposed revisions to the eligibility requirements for the CMS Transitional Drug Add-on Payment Adjustment (“TDAPA”) program, which has the potential to provide two years of add-on reimbursement for certain qualifying new drugs. Under the proposed revisions to the TDAPA rules, if finalized, ESRD drugs approved by the FDA under the following types of NDAs would be ineligible for TDAPA, effective as of January 1, 2020: (a) NDA Types 3, 5, 7 and 8, (b) NDA Type 3 in combination with NDA Type 2 or NDA Type 4, (c) NDA Type 5 in combination with NDA Type 2, or (d) NDA Type 9, when the “parent NDA” is NDA

Type 3, 5, 7 or 8.

As previously disclosed, the Company has filed an NDA for the intravenous formulation of Triferic. The FDA has not informed the Company what the classification will be for the I.V. Triferic NDA, although the two prior Triferic NDAs that have been approved were Types 3 and 5. If the I.V. Triferic NDA is classified as either of those Types, or any of the other excluded NDA Types listed in the Proposed Rules, the Company believes that it could be adversely impacted by the Proposed Rules, because it would not be eligible for reimbursement under the Proposed Rules relating to CMS’ TDAPA program. The Company previously disclosed projections for the overall peak Triferic market opportunity in the United States have been based on an assumed market price for I.V. Triferic that is within the CMS reimbursement bundle payment system and not a sustained, higher price based on TDAPA eligibility.

CMS is accepting comments on the Proposed Rules through September 27, 2019. Rockwell plans to vigorously oppose this change in the TDAPA eligibility requirements.

The Company is currently assessing the impact the Proposed Rules would have on current inventory valuations and stock compensation arrangements if such proposed rule would be finalized and the type of classification for the I.V. Triferic NDA was included.