Gordon Sangster
Analyst · Craig-Hallum. Please proceed
Thanks, John. Let me give you some financial highlights from the fourth quarter as well as the full year. Turning to Slide 4 in our presentation, total revenues for the fourth quarter of 2016 were $10 million. This was a strong showing against the difficult comparison from the prior year that included a $3.1 million royalty settlement payment from a non-core legacy customer. So, good growth excluding this one-time payment was 17%, which is consistent with the full year. R&D revenues were $5.3 million for the quarter, down from $6.4 million in the prior year quarter which includes that $3.1 royalty settlement payment. In the 2016 fourth quarter, we recorded $1.8 million in previously deferred revenue from the early completion of our technology transfer to Merck. Product sales for Q4 2016 were $4.2 million, down by 200,000 from the prior year while the decrease was due to fluctuations in demand for our enzyme products. We continue to increase shipments of enzymes to Merck for the production of sitagliptin, the active ingredient in Januvia. Revenue from our revenue sharing arrangement for argatroban injectable drug with Exela contributed $375,000 to the fourth quarter total. We expect revenues from this agreement to continue in this range in the coming quarters. Gross margin as a percentage of total revenues for the fourth quarter of 2016 was 77%. This compares with 78% for the fourth quarter of 2015, which again reflected the recognition of the royalty settlement payment. Gross margin as a percentage of product revenues for the fourth quarter of 2016 was 46% compared to 42% from the fourth quarter of 2015, reflecting an improved sales mix. Turning to operating expenses, R&D expenses were $6 million for the fourth quarter of 2016, a 14% increase from the prior year period primarily due to costs associated with higher headcount and higher outside services related to our PKU biotherapeutic development. SG&A expenses for the fourth quarter of 2016 were $7 million, a 16% increase from the prior year period and reflected a foreign tax receivable write-off and increased costs due to higher headcount mainly due to additions to our business development achievement. The net loss for the fourth quarter of 2016 was $5.3 million or $0.13 per share. This compares with a net loss of $2.1 million or $0.05 per share for the fourth quarter of 2015. On a non-GAAP basis, adjusted net loss for the fourth of 2016 was $2.8 million or $0.07 per share, which compares with adjusted net income for the fourth quarter of 2015 of $600,000 million or $0.02 per diluted share. Turning to our full year financial results, total revenues for 2016 were $48.8 million, which is up 17% compared with 2015. As John stated, this was at the high end of our 2016 revenue guidance range. Total revenues for 2016 included $31.3 million in R&D revenue, $15.3 million in product sales and $2.2 million from the revenue sharing arrangement. Gross margin as a percentage of total revenues for 2016 was 80%, also meeting our 2016 guidance. R&D expenses for 2016 were $22.2 million which compares with $20.7 million for 2015. The increase was due to higher consulting fees which we incurred for the evaluation of potential new drug development targets, marking an important investment in our future growth as well as higher fees for outside services and increased cost associated with our higher headcount. SG&A expenses were $25.4 million for 2016, up from $22.3 million for the prior year mainly due to higher legal expenses associated with our intellectual property litigation, higher consulting fees and the exploration of business development opportunities and the cost related to the higher headcount as I previously mentioned. For 2016, we reported net loss of $8.6 million or $0.21 per share, and this compares with the net loss for 2015 was $7.6 million or $0.19 per share. On a non-GAAP basis, we’re reporting adjusted net income for 2016 of $1.7 million or $0.04 per diluted share. This compares with adjusted net income for 2015 of $3 million or $0.07 per diluted share. Cash and cash equivalences as of December 31, 2016 were $19.2 million versus $23.2 million as if December 31, 2016. We expect to continue to tightly manage our costs related to new product development and litigation. Turning to Slide 5, we're introducing financial guidance for 2017 as follows. We expect total revenue to reach between $50 million and $53 million. We also provide guidance on product sales of $21 million to $23 million, which is a 37% to 50% increase over 2016. Guidance on gross margin for product sales is between 37% and 39%, which is an increase over gross margin on product sales of 36% for 2016. Our revenue guidance assumes the recognition of an upfront payment and the achievement for our first milestone related to our third CodeEvolver licensing agreements, which we expect to announce in the second half of 2017. Given the anticipated timing of this agreement, we expect total revenues to be higher in the second half of 2017 versus the first half of the year. Finally, we are providing guidance for operating expenses which is combined total of R&D and SG&A expenses to increase by between 6% and 8% over 2016. This assumes the full year of expenses related to the development of our PKU drug candidate as we advanced this asset towards an IND. Please note that our reconciliation GAAP to non-GAAP financial metrics is included on Page 8 of this presentation. With that, I'd like to turn the call back to John.