Robert L. Chioini
Analyst · Craig-Hallum
Thanks, Paul. Good afternoon, thank you for joining us. Today, I will briefly cover our third quarter results then provide an update on our clinical and strategic progress. Joining me on the call today will be our Chief Financial Officer, Tom Klema, along with Drs. Pratt and Gupta, in light of our recent successful FDA Advisory Committee Meeting. Starting with the third quarter numbers. We had a strong quarter, sales were up 5% over last year. And sequentially, sales were up 5.5% over the second quarter. The gross profit increased 39% over last year's third quarter and was up 30% over the first 9 months of 2014. We continue to see positive trends. As we discussed in previous calls, conversion to CitraPure as the standard of care concentrate product, coupled with liquid to dry product conversion, continues to drive improved operating results. This, along with our efforts to reduce costs will have a positive impact on our margins and our gross profits. Gross profit in 2014 is up $1.4 million and our gross profit margins are up 3 percentage points. Loss for the quarter was $4 million, $9.2 million less than last year's third quarter. R&D was $1.3 million, $9.3 million less than Q3 last year. As mentioned previous, we continue to expect R&D expense to be in the $1.5 million range. Year-to-date loss was $14.9 million, significantly less than the $40.5 million last year. R&D is $27.5 million less year-to-date. Overall, we are pleased with our progress and results for the quarter. Also, as you may know, we received $43 million in cash in early October. This was in addition to the $12 million in cash and investments we had at the end of September. So our cash and liquidity status is very solid. Regarding our partnership with Baxter. On October 2, we entered into an exclusive commercialization agreement with Baxter. I laid out the structure of this transaction previously, but I want to reiterate a few key points. The deal does not include Triferic or Calcitriol. It is exclusive to our concentrate asset. We continue to own and operate the business. Our customer service group takes and processes orders and our transportation group routes and delivers product. Additionally, we will also continue to co-promote in support of Baxter. All costs to manage customer orders and deliveries are passed on to Baxter at a slight markup. This effectively eliminates our costs and risk on fuel and transportation. Gross margins begin in line with current margins and increase each year thereafter. Cost increases are passed on to Baxter as well. We intend to expand our manufacturing and sales footprint in the West. We will receive $10 million to build a manufacturing facility which will service customers in the West and which we will continue to own and operate. Interest expense will be reduced with the repayment of debt by the end of 2014, which is a meaningful amount of interest cost that will now flow in the RMTI's net profit. In summary, this deal brought us significant cash and enables us to increase margins and expand more rapidly in both the U.S. and internationally, utilizing Baxter's global market presence and infrastructure. It increases revenue growth and immediate gross and operating margin expansion. Combined with the multiple cash investments by Baxter, this is a very strong and high-value partnership. And Rockwell continues to operate and increase its brand presence in the concentrate market. Now let's talk about Triferic. Most of you, by now, are aware of the positive outcome from the FDA Advisory Committee meeting that was held last Thursday. We obviously are extremely pleased with the panel's 8 to 3 vote in favor of Triferic to treat iron loss and maintain hemoglobin in hemodialysis patients. The efficacy and safety studies formed a convincing body of evidence showing that Triferic works as proposed. And the totality of the data support the clinical benefit, safety profile and unmet medical need. We are very excited to bring this important drug to the market and we look forward to working with the agency in accomplishing this goal. Our PDUFA date is January 24, 2015. Based on their comments during the meeting, it appeared the majority of the panel members agreed that Triferic effectively delivered iron and maintain hemoglobin. We are also extremely pleased that the nephrologists on the panel, in particular, support our belief that the current medical practice of using IV iron to address maintenance therapy is not satisfactory. We heard discussion about the limitations and risks of IV iron use, including infections and the need to replace iron in this patient population in a physiological and safe manner. So as we start thinking about commercializing Triferic and the positioning of the product in the marketplace, we are convinced that there is a genuine unmet need that Triferic addresses. With respect to ESA-sparing in the PRIME study, we note that the panel was not asked to vote on the inclusion of this claim in our indication. And while the data from the PRIME study are positive and provides solid evidence on the ESA-sparing effect of Triferic, the panel noted that it was a single trial. We view the CRUISE studies as further supportive evidence that Triferic is able to reduce the need for ESA as the placebo arm showed hemoglobin concentration declining when the ESA dose was held constant. This means that to keep hemoglobin stable in the placebo arms, the ESA dose needed to be increased. The 0.36 gram per deciliter difference between Triferic and placebo in the CRUISE studies is about equivalent to the same ESA decrease we saw in the PRIME study because the decrement in hemoglobin in both studies was similar. So we view all 3 studies, the PRIME and 2 CRUISE as compelling data showing Triferic is able to reduce ESA. However, we are currently certainly supportive of the panel's view that further study would be valuable in further exploring this benefit. I would like to take this opportunity to thank my entire clinical team, including Drs. Pratt, Gupta, Lynn [ph] and Fishbane who did an exceptional job in preparing and presenting our clinical data and addressing the questions from the FDA in the panel. On the heels of this positive majority vote from the Advisory Committee in favor of Triferic to treat iron loss and maintain hemoglobin in hemodialysis patients, we have a body of work that is now in the public domain and that clearly demonstrates what Triferic is, how it works and why it is so special, and that Triferic has the potential to become the standard of care for iron delivery for dialysis patients in the U.S. once approved by the FDA. This would be the first FDA-approved maintenance iron therapy. As we think about post-FDA approval and positioning Triferic in the market, the AdCom meeting provided us an excellent platform to educate dialysis providers and patients about Triferic, its use and its potential benefits as an iron maintenance therapy. The briefing book, the slide presentation and the discussion that followed were and will continue to be an ideal vehicle for educating potential customers about how Triferic can address their needs and provide important clinical benefits. As you know, dialysis providers are very interested in improving patient outcomes and reducing their cost per treatment. And the Triferic clinical data has clearly shown that it accomplished both. Our many years of success in launching new products into the renal market, coupled with the first-ever maintenance iron therapy able to address the ongoing iron loss in dialysis patients and the potential clinical and pharmacoeconomic benefits included give us great confidence that we will have rapid uptake in sales upon commercial launch of Triferic. Regarding our Calcitriol launch, we have a solid prelaunch demand. We have one manufacturer producing product, while 2 others are in the process of starting production. Our current launch plan is to start supplying customers in Q1. We anticipate solid commercial success with Calcitriol. Regarding our ongoing business development efforts, we continue to evaluate numerous opportunities both out-licensing and in-licensing. In our discussions, our goal is to obtain the highest-value partner and economics. I will now turn the call over to Tom for his comments on the financial results.