Operator
Good day, ladies and gentlemen, and welcome to the Q1 2013 IGI Laboratories Earnings Conference Call. My name is Derek and I’ll be your conference operator for today.
(Operator instructions.) As a reminder, this conference is being recorded for replay purposes.
I would now like to read the Safe Harbor: except for historical facts, the statements on this call made by IGI Laboratories, Inc., are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. For example, statements about the company’s anticipated growth and future operations, the current or expected market size for its products, the success of current or future product offerings, the research and development efforts, and the company’s ability to file for and obtain US Food and Drug Administration approvals for future products are forward-looking statements.
Forward-looking statements are merely the company’s current predictions of future events. The statements are inherently uncertain and actual results could differ materially from statements made herein.
There is no assurance that the company will achieve the sales levels that will make its operations profitable or that the FDA filings and approvals will be completed and obtained as anticipated. For a description of additional risks and uncertainties, please refer to the company’s filings with the Securities and Exchange Commission including the Annual Report on Form 10(k) and its latest quarterly report on Form 10(q).
The company assumes no obligation to update its forward-looking statements to reflect new information and developments. I would now like to turn the conference over to Mr.
Jason Grenfell-Gardner, President and Chief Executive Officer. Please proceed.
Jason Grenfell-Gardner
Thank you, Derek, and good afternoon ladies and gentlemen. Welcome to the IGI Laboratories business update covering Q1 2013.
I am Jason Grenfell-Gardner, the President and CEO of IGI and I am joined by Jenniffer Collins, our Chief Financial Officer. Thank you for joining us today.
I’ll discuss highlights of our business performance and strategy for the future and Jenniffer will then review our financial results for Q1. As you can see from our press release issued earlier today, IGI has accomplished quite a lot since the company reported results in Q1 2012.
IGI has now begun successfully commercializing our IGI label product and we’ve continued to grow our core business. With just over 40 people on our IGI team, we’ve been able to grow total revenue for our company to $3.7 million in Q1 2013.
That’s more than double our total revenue at this time last year. As we’ve discussed on the last few calls, the key to our strategy centers on the growth of our business and the achievement of profitability.
In order to grow this business we knew we had a lot of work to do, and we narrowed our focus to three distinct areas: first, we needed to bring our IGI generic topical pharmaceutical products to market; second, we needed to grow our pipeline of these generic topical products; and third, we needed to grow our contract manufacturing and formulation services businesses. So let me update you on our three strategic objectives.
First, let me start by talking about our IGI generic products. A total of $1.4 million of our Q1 revenue was generated from the sales of our own generic pharmaceutical products.
IGI is now one of the only publicly held pure-play generic pharmaceutical companies dedicated to the manufacturing and development of topical pharmaceutical products – I think maybe we’re one of two. Considering just over two years ago we were solely a contract manufacturing and formulation services company, I’d say that’s quite an achievement.
We have contracts in place with all of the major wholesalers, many of the major retailers, and we continue to expand our customer base. We’re now marketing and distributing three IGI label generic pharmaceutical products, all of which are being sold in thousands of pharmacies across America.
While our Manager of National Accounts is diligently expanding our customer base, we understand we need to continue to expand our portfolio of available IGI products at the same time. And that brings me to the second part of our strategy – growing the portfolio.
IGI needs to continue to build its portfolio to consistently maintain a full pipeline of new products. We’re attacking this part of our strategy on two fronts: first, we’re aggressively seeking business development opportunities to add products to the portfolio.
At the same time, our Development Team remains focused on the fulfillment of our commitment to submit at least six abbreviated new drug applications, or ANDAs, this year alone. Since our Head of R&D joined us in December of last year we’ve made a great deal of progress on the development front.
Already this year we’ve filed two ANDAs with the FDA and we finalized our product selection for development in 2013 and 2014. We now have ten applications pending with the FDA, and based on recent IMF data we believe the addressable market for these products totals around $210 million.
In addition to these applications, we currently have a number of our products under active development today that will facilitate the further submissions. Our R&D Team understands that this pipeline is a major key to IGI’s success and we’ll continue to support these organic development efforts in the days and months ahead.
The current average review time for some of these applications by the FDA is now around 32 months so we believe it’s critical for us to identify opportunities outside of IGI as well. As we talked about when we spoke last month, we have finalized the transaction to purchase Econazole Nitrate Cream 1% on February 1, 2013.
We’re in the process of completing the necessary steps to ensure the transfer of the manufacture of this product to IGI will be seamless and we will obtain the necessary approvals to begin making this product at our facility this summer. This product has an addressable market, again based on IMF data, of around $14 million.
At the same time we remain actively engaged in the search to find products, applications, or intellectual property that we can acquire and consolidate into IGI. Transactions like these can be integrated into our sales channels and our manufacturing facilities relatively quickly and enable us to accelerate the growth of our IGI product portfolio beyond our own organic R&D pipeline.
The introduction of new products to our manufacturing facility like this is not new to our team and that’s also the key to the third part of our strategy – continuing to grow our contract services business. Our contract service business has not only the capabilities to execute turnkey manufacturing to a wide range of topical products but we can also offer our customers a suite of development services from site transfer of an existing product to the formulation of a new product, up to and including the filing of an ANDA or a 510K medical device admission to the FDA on their behalf.
You all may remember our team submitted two ANDAs on behalf of one of our pharmaceutical partners at the end of 2012. Our facility is FDA approved for the manufacturing of pharmaceuticals and medical devices and we have the capacity and capability to expand this business.
As we’ve talked about before, continuing to add more pharmaceutical customers to this business will allow us to continue to invest in the development efforts required for the long-term growth. You’ll see from the results, which Jenniffer will discuss in a minute, that we grew our contract service business 24% over the same quarter last year and improved our margins from 25% to 30% year-over-year.
This was attributable not only to the launch of our IGI label products but also the result of our successful efforts to shift our product mix to include more pharmaceutical customers. We also did add one non-pharmaceutical customer in Q1.
As we discussed on the last call, we executed a new contract manufacturing relationship with minimum commitments that will make use of our existing formulation and of our proprietary Novasome technology. This contract includes a $3 million commitment over the coming three years and is generally at greater margins than our typical contract services customer as these products are based on our own intellectual property.
We’ll begin manufacturing certain of these products under this agreement during Q2 this year. As a final thought on all of this it’s worth remembering that our growth strategy has three distinct initiatives but the foundation to all of them remains the same, and that’s our dedication to quality.
We’ll continue to invest in this area of our business to ensure the foundation of our growth remains as strong as ever. We’re now one quarter of our way through 2013, and as we’ve said 2013 is a year of transformation for IGI.
We remain committed to our target to double our 2012 total revenue and achieve profitability in 2013. We have made considerable progress so far this year.
Let me now turn the presentation over to Jenniffer Collins, our CFO, for a more detailed discussion of the Q1 financials.
Jenniffer Collins
Thanks, Jason. Good afternoon, everyone, and again thanks for joining us today.
Total revenue for Q1 2013 was $3.7 million, an increase of 101% over the same quarter last year. In addition, our total revenue this quarter increased sequentially 60% over Q4 2012.
Our total revenue increase of $1.9 million as compared to 2012 was attributed to $1.4 million of revenue generated from the launch of our first three IGI labeled products and $500,000 of additional revenue generated from our contract services business. Our IGI product portfolio now includes three authorized generic products which we have sold to wholesalers and retailers under the contracts put in place over the last few months.
Now that we’re selling IGI labeled products I’d like to take a few minutes to talk about the accounting treatment for that. As customary in the pharmaceutical industry, our gross product sales are subject to a variety of deductions which led to the $1.4 million of our reported net IGI product sales.
When we record gross revenues from the sale of our products, we make estimates of various allowances which reduce product sales. These include estimates for chargebacks, rebates, cash discounts and returns, and other allowances.
Currently these provisions are based on industry standards as well as our existing contracts with our customers. As we obtain actual data over time we will continue to evaluate and modify these estimates based on historical payment experience, historical relationship to revenues, estimated current inventory levels, and our contract sales terms with direct and indirect customers.
The provision for chargebacks is our most significant gross-to-net sales allowance. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to us by our wholesaler customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product.
Our large wholesaler customers represent the majority of our chargeback allowance. We will continue to monitor current pricing trends and other inventory levels to ensure the liability for future chargebacks is fairly stated.
As I mentioned, we grew our contract services business by $0.5 million as compared to Q1 last year. As you may remember, in 2012 we recorded almost $2 million in revenue related to our contract formulation services business.
During Q1 2012 we executed an agreement with a pharmaceutical customer which included the site transfer of one of their pharmaceutical products which previously had been manufactured in another facility. We began to manufacture this product in Q4 2012 and this customer then represented a significant portion of our product sales in Q1 2013.
The turnkey manufacturing of pharmaceutical products is an efficient use of our existing capacity and allows better visibility for our capacity planning as the ordering patterns of our pharmaceutical partners are much more predictable. And these products typically allow for better margins than the products manufactured for our cosmetic partners.
Our gross profit increased to 30.1% in Q1 2013, up from 25.4% in the same period last year. The launch of our IGI labeled products in addition to the shift in our product mix to include more products manufactured for our pharmaceutical partners helped improve our margins in 2013.
In Q1 2012, out of all of our contract service revenues 48% came from pharmaceutical products, 4% from OTC products, and 48% from cosmetic products. This year we saw a significant change in the product mix.
In Q1, 64% of our contract services revenue came from pharmaceutical products, 1% from OTC products, and 34% from cosmetic products. The margins for products within each product type can vary significantly.
For instance, as Jason mentioned in Q1 we executed a three-year turnkey agreement to manufacture some cosmetic products for Juventio. These products utilize our proprietary Novasome technology and as such will generate higher margins than our typical cosmetic products.
This agreement has a total minimum commitment of $3 million in purchases over the term of the agreement and we’re scheduled to begin to manufacture those products this quarter. With the significant growth in revenue, SG&A as a percentage of sales for the three months ended March 31, 2013, as compared to last year was only 18% this year and 36% in the same three months last year.
We do plan to continue to manage our administrative costs while still expanding our customer base, and we’ll expand our topical prescription drug portfolio. And more importantly, as we reach profitability we will make some additional investments in sales and marketing in order to successfully place these products in the market.
As Jason pointed out, the value creation for this business is in our R&D pipeline. To that end we spent $700,000 in Q1 as compared to $500,000 in the same quarter last year.
Our R&D investment included fees related to our one ANDA filing in Q1 in accordance with the fee structure (inaudible) from the US FDA that was implemented Q4 last year, and of course the addition of Dr. Ken Miller as our Senior Vice President of Research and Development in December of last year.
We expect to continue to increase our R&D costs as we focus on expanding the development of our portfolio of generic topical products and adding to the ten submissions we already have on file with the US FDA. Net loss for Q1 was $0.01 per share as compared to $0.02 per share in the same quarter last year.
Our net loss of approximately $257,000 included $658,000 of R&D expenses. Year-to-date we’ve used $1.6 million of cash in our operations.
While this does include the $700,000 used for R&D expenses you will see that the launch of our IGI label products resulted in a significant investment in our accounts receivable for the first three months of 2013. Our accounts receivable increased $1.5 million as compared to December of 2012.
While we do expect this investment to continue over time, as our customer relationships mature we expect this investment will result in reaching profitability in 2013 as projected. We will continue to invest in R&D and will manage our operating resources and increase our sales efforts in order to ensure that we meet this goal.
Execution of our strategy will allow us to generate cash in this business and will allow us the opportunity to explore additional opportunities to accelerate growth. Our cash use and investment activities of $1.5 million included the $1.4 million which we paid Prasco, a private pharmaceutical company located in Ohio, in February of 2013.
We are obligated to pay them an additional $400,000 upon completion of the transfer of manufacturing in the middle of this year. We did draw $1 million from our existing credit line and we’ve executed a term sheet with our existing lender to expand the lending capabilities under this agreement.
Things have been progressing well on our investor communications front. We spoke at the 25th Annual ROTH Investor Conference sponsored by ROTH Capital in California next month.
We’re scheduled to present at the 12th Annual Healthcare Conference at Needham & Company in New York City on this coming Tuesday. This presentation will be available via webcast on our website as well.
We are also in the process of completing a project to update our IGI website to incorporate the new vision of our business and make it easier for investors to find information regarding our business. We’re actively talking to investors and potential investors and hope to add additional conference appearances to our list.
Jason and I believe in IGI and we’re committed to meeting with investors and potential investors to improve our investor relations in 2013. And I’m always available to answer your questions so don’t hesitate to reach out.
Jason and I are very grateful for your participation today and look forward to updating you soon. I’ll now turn the call back to Jason for his closing remarks.
Jason Grenfell-Gardner
Thanks, Jenniffer. Before we turn it over to questions I want to provide just a couple further thoughts.
Having launched our first IGI products and proven that we can achieve market positions, IGI has now completed that pivot to the pharmaceutical market that we set out and that we’ve been talking about. The next phase of our growth requires us to continue to accelerate our ANDA pipeline and to look for opportunities to add to our portfolio.
Your team at IGI has been doing great work all of these past few months as evidenced by these results, and we’ll continue to drive IGI forward in the months ahead. I want to thank you again for your support during these past few months.
Jenniffer and I have enjoyed having the opportunity to meet and speak with a number of you and we look forward to continuing to tell the IGI story. With that, Derek, I’d be happy to open this up for questions.
Operator
(Operator instructions.) And our first question is coming from the line of Frank Gerardi, Univest Management.
Frank Gerardi
Hi, congratulations to all of IGI for an outstanding Q1. I’m very pleased and I just have a couple of questions.
One, with the site transfer of the Econazole Nitrate, do you expect margins to increase over the people you bought it from? That’s question number one.
Jason Grenfell-Gardner
Well, I don’t think that we have necessarily the full picture of what the margin potential was at the previous marketers and we don’t have transparency to all of that. What I would say is that it’s a great opportunity for IGI.
Anything that we can bring into the facility that helps contribute to overhead and to fixed costs is a benefit to us, and it will help to continue to make us more efficient.
Frank Gerardi
Thank you. Second question is with the pending FDA approval of your first generic product, what do you expect the lead time to be from approval to launch once we see approval?
Jason Grenfell-Gardner
I’d try to be as efficient as possible around that and it really depends on the degree of comfort we get around the approval timeline. If it’s something that we feel comfortable manufacturing certain stock at risk we will do that to be able to launch as quickly as possible.
There’s no sense for us to have an approval and not be able to use it so we want to keep that delay as brief as we can.
Frank Gerardi
Thank you and good luck next week with the Needham conference. Thank you again.
Jason Grenfell-Gardner
Thanks, Frank.
Operator
(Operator instructions.) The next question is from the line of Alan Troy, private investor.
Alan Troy
Hi Jason. I don’t really have a question; I just want to congratulate the entire IGI staff for doing a fantastic job during Q1.
It’s quite a turnaround. Revenues are really growing and it looks very promising.
And I was also very pleased to see insider buying during Q1 which shows confidence in the company. Again, congratulations and keep up the good work.
Jason Grenfell-Gardner
Thanks, Alan.
Operator
Your next question is coming from the line of Marco Rodriguez, Stonegate Securities.
Dan Trang
Hello, this is actually Dan Trang sitting in for Marco Rodriguez. A question about the new contract with the customer that’s $3 million over three years – am I correct?
Jason Grenfell-Gardner
Yes, that’s correct.
Dan Trang
I’m wondering how that’s going to be recognized in your financial statements. Do you plan to amortize that over time or can you give a little color behind that?
Jason Grenfell-Gardner
It’s going to be driven on a purchase order basis. $3 million is the minimum order quantity commitment.
It’s certainly not a ceiling and it’s actually broken down across three products, so there’s a sort of mix-and-match approach to that. So as these purchase orders come in and get fulfilled we will recognize that revenue and then at the end of any one-year contract period we’ll look to ensure that the minimum quantities have been fulfilled.
If they have, great; if not, IGI has the ability to bill that customer for the difference. And that will be on an annual adjustment.
Dan Trang
Okay. Following up, in regards to the product mix going from 48% for your large pharmaceutical orders to 64%, and that is obviously reflected in the margins – I’m kind of wondering what was the cause of that, to get that big shift.
Jason Grenfell-Gardner
I think some of this comes down to the timing. As you’ll remember, in 2012 IGI recognized what I would say is significantly more revenue on the product development side as it facilitated the site transfers for some of our more pharmaceutical Rx customers.
As you transition then into the actual manufacturing piece of this it’s going to affect your manufacturing mix and that’s just the natural ramp up and the natural lifecycle of those types of transactions, so I think that’s where it is now. There will continue to be, as ever in a contract manufacturing business there will continue to be some bumpiness to this but our goal is to try to continue to grow the more pharmaceutical Rx side of our business.
Dan Trang
Thank you very much, Jason and Jenniffer.
Jason Grenfell-Gardner
Thanks, Dan.
Operator
At this time I’m showing no further questions in queue. I would like to turn the call back over to Mr.
Jason Grenfell-Gardner for any final statements.
Jason Grenfell-Gardner
Thanks, Derek. Thanks again everyone for participating on this IGI earnings call.
We look forward to seeing some of you at the Needham conference in New York next week and we do encourage you, if you’re unable to attend, to listen to the presentation or to see the webcast which will be on the website. Also as a reminder our Annual Meeting will be May 22, 2013, and all shareholders are welcome to join us at that shareholder meeting in New York.
Thanks again and have a great day.
Operator
Ladies and gentlemen, that concludes today’s conference. We thank you for your participation and you may now disconnect.
Have a great day.