Sal Guccione
Analyst · Craig Hallum Capital Group. Please go ahead
Good morning, Jody. Thank you, Jody, and good morning, everyone. Thank you for joining us on Aceto's third quarter fiscal 2017 earnings conference call. Our third quarter results reflect our first full quarter with the inclusion of the products acquired from Citron and Lucid. That strategic acquisition enabled us to achieve solid double digit growth in sales and gross profits during the quarter. On our adjusted earnings per share basis, the third quarter came in just shy of our expectations. With the addition of Citron and Lucid's generic product into our company, our Human Health and Pharmaceutical Ingredients segment together accounted for over 75% of total sales for the first time since we embarked on our strategy to transition the company towards Human Health. Company net sales for the third quarter of fiscal 2017 were about $190 million, which is an increase of 20.5% from the $158 million reported in the third quarter of fiscal 2016. Our total gross profit rose 10.5% to $42.3 million from $38.3 million in the prior year's period. Gross margin for the third quarter was 22.3%, compared to 24.2% in the prior year period. Doug Roth will give you performance details on the individual segments in a moment. And I want to focus my comments on the performance of our Human Health segment where sales and gross profit excluding the contribution from Citron and Lucid were below those achieved last year. This quarter we continue to see its competitive headwinds in the generic industry coming from new generic launches, as well as from continued pressure related to customer consolidation. In particular, as previously discussed, Rising continue to see heighten competition for one of its important generic products that began to our last year's fourth quarter. In addition, some of our more matured products saw pricing pressure which we were able to partially offset through new product launches. As the fiscal year progress, we've seen more frequent price and share negotiations which create more opportunities for the business mix to shift both positively and negatively. That said with Citron's products and Aurobindo's supply capability is now added to our company, we are now better equipped to deal with those industry dynamics. From an operating perspective, we resolved the API supply issues that had previously impacted two of our Rising products. Those products are now back online commercially. We also made good progress in minimizing approval to launch time gaps for the new products. During the quarter, we launched total of six new products, four from Rising and two from Citron. We now have two significant launches of products from Rising portfolio. One is called Zileuton Extended Release Tablets, that one Rising holds ANDA on and Capecitabine Tablets. Zileuton is indicative for the treatment of Asthma and according to IMS Health has US sales of about $75 million for the 12 months ended December 2016. Capecitabine which is used for the treatment of metastatic breast cancer has sales of just under $400 million for the 2016 calendar year. Our remaining product launches were Voriconazole Tablet and Paricalcitol from the Rising pipeline and [indiscernible] from the Citron pipeline. These six launches now bring our year-to-date total to 11. Consistent with our previous guidance we still expect to launch 3 to 6 products from the Rising pipeline in the fourth quarter, bringing that total to 12 to 15. On a Citron side, we had made strategic decision during the acquisition transition that the initial labeling process with our manufacturing parter Aurobindo would involve replacing the Citron labels and NDC number with Rising label and NDC numbers. This was done for two reasons. First, any time an NDC label change occurs once the product is commercialized, that can be a catalyst for launch first circa rebate on that product to other suppliers. Second, we believe that leveraging the Rising brand in the marketplace is the best course of action for a long term value creation. And then during the quarter, as we were preparing the launch schedule, we also made a decision to integrate the new serialization labeling protocol that would become a legal requirement this November. Because of that decision, Citron products will take an out of the queue and set back the launch cycle somewhat. As a result, we now expect to launch seven Citron related products in the fourth quarter for a total of nine this fiscal year versus our prior plan of launching about 15 of those products. Launching the balance of the approved products acquired from Citron by the end of calendar 2017 remains a high priority for us. Otherwise our integration activities have been proceeding as planned. We've been preparing to consolidate warehouses. We've been integrating our reorder pieces sums and we are on track to capture our fiscal 2018 planned synergies. The overall results from Citron and Lucid's products thus far are on track to meet our fiscal 2017 expectation. We are generally pleased with how our work together is progressing. During the quarter, we reassessed our development projects in order gauge the future success on the pipeline. During this process, several projects were terminated due to market dynamic and to our technical challenges. And with that pruning, that will allow us to redeploy those R&D dollars towards better projects. As of the end of April, we now have 154 projects in our development portfolio including 36 ANDAs currently on filed with FDA and 44 approved or tenably approved products. Together having a total addressable market value of about $10 billion according to IMS data. Turning to balance of fiscal 2017. We are updating our outlook for sales and gross profit since the last time we discussed guidance on our second quarter call. In part, this change reflects our revised launch schedule for the fourth quarter, and in part is due to competitive market dynamics that I described earlier. In some cases, we are not achieving the market share quickly as we've planned. In other cases, price erosion is greater than we anticipated. On the other hand, some positive developments have also occurred. For example, current market dynamic suggest that pending new product launch force anticipated for this fourth quarter could produce substantially greater sales on profit that were previously model. So pulling all these factors together, we now expect to see the fiscal 2017 sales growth to be in the low to mid-teen percentage range and non-GAAP adjusted EPS to be flat with to 10% below fiscal 2016's level. On a GAAP basis which reflects the related cost and non cash purchase accounting charges, EPS is expected to be below last year by roughly 50% to 60%. Lastly, based on our current pipeline of project with Rising, we continue to project R&D spending of between $6 million and $8 million for the year. We position the company to return to growth in fiscal 2018. We've been solving operational challenges. We are pushing forward with new product development as we continue to invest in and augment our current pipeline. We are integrating Citron's products into Rising. And we've added key personnel for the business. Through the acquisition of Citron and Lucid products, we are in a strong position now with greater scale and streamline supply from Aurobindo to more effectively compete in the generic industry. Longer term, we are enthusiastic about our growth prospects from our standard commercial portfolio, and from our standard pipeline of development product, and we remain committed to achieve a strategic transition towards Human Health. With that I'll turn the call over to Doug for discussion of our financial results and then open the call up to questions. Doug?